[Federal Register Volume 78, Number 65 (Thursday, April 4, 2013)]
[Proposed Rules]
[Pages 20268-20277]
[FR Doc No: 2013-07730]

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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

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Federal Register / Vol. 78, No. 65 / Thursday, April 4, 2013 /
Proposed Rules

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 876, 882, and 892

[Docket No. FDA-2013-N-0195]

Effective Date of Requirement for Premarket Approval for Three
Class III Preamendments Devices; Reclassification of Sorbent
Hemoperfusion Devices for the Treatment of Poisoning and Drug Overdose

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed order.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a proposed
administrative order to require the filing of a premarket approval
application (PMA) or a notice of completion of a product development
protocol (PDP) for the following three class III preamendments devices:
Sorbent hemoperfusion devices for the treatment of hepatic coma and
metabolic disturbances; cranial electrotherapy stimulator for the
treatment of depression, anxiety, and insomnia; and transilluminator
for breast evaluation. FDA is also announcing the opportunity for
interested persons to request that the Agency change the classification
of any of the aforementioned devices based on new information. In
addition, FDA is proposing to reclassify sorbent hemoperfusion devices
for the treatment of poisoning and drug overdose, a preamendments class
III device, into class II (special controls) based on new information
respecting the device. This action implements certain statutory
requirements.

DATES: Submit written or electronic comments on this proposed order by
May 6, 2013. FDA intends that, if a final order based on this proposed
order is issued, anyone who wishes to continue to market the sorbent
hemoperfusion devices for the treatment of hepatic coma and metabolic
disturbances; cranial electrotherapy stimulator for the treatment of
depression, anxiety, and insomnia; or transilluminator for breast
evaluation will need to file a PMA or a notice of completion of a PDP
within 90 days of the effective date of the final order. See section
XIII of this document for the proposed effective date of any final
order that may publish based on this proposed order.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2013-
N-0195 by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following way:
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket Number FDA-2013-N-0195 for this action. All comments
received may be posted without change to http://www.regulations.gov,
including any personal information provided. For additional information
on submitting comments, see the ``Comments'' heading of the
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Michael Ryan, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1615, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background-Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended
by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L.
94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the
Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L.
105-115), the Medical Device User Fee and Modernization Act of 2002
(Pub. L. 107-250), the Medical Devices Technical Corrections Act (Pub.
L. 108-214), the Food and Drug Administration Amendments Act of 2007
(Pub. L. 110-85), and the Food and Drug Administration Safety and
Innovation Act (FDASIA) (Pub. L. 112-144), among other amendments,
established a comprehensive system for the regulation of medical
devices intended for human use. Section 513 of the FD&C Act (21 U.S.C.
360c) established three categories (classes) of devices, reflecting the
regulatory controls needed to provide reasonable assurance of their
safety and effectiveness. The three categories of devices are class I
(general controls), class II (special controls), and class III
(premarket approval).
    Under section 513(d) of the FD&C Act, devices that were in
commercial distribution before the enactment of the 1976 amendments,
May 28, 1976 (generally referred to as preamendments devices), are
classified after FDA has: (1) Received a recommendation from a device
classification panel (an FDA advisory committee); (2) published the
panel's recommendation for comment, along with a proposed regulation
classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
    Devices that were not in commercial distribution prior to May 28,
1976 (generally referred to as postamendments devices), are
automatically classified by section 513(f) of the FD&C Act into class
III without any FDA rulemaking process. Those devices remain in class
III and require premarket approval unless, and until, the device is
reclassified into class I or II or FDA issues an order finding the
device to be substantially equivalent, in accordance with section
513(i) of the FD&C Act, to a predicate device that does not require
premarket approval. The Agency determines whether new

devices are substantially equivalent to predicate devices by means of
premarket notification procedures in section 510(k) of the FD&C Act (21
U.S.C. 360(k)) and 21 CFR part 807.
    A preamendments device that has been classified into class III and
devices found substantially equivalent by means of premarket
notification (510(k)) procedures to such a preamendments device or to a
device within that type (both the preamendments and substantially
equivalent devices are referred to as preamendments class III devices)
may be marketed without submission of a PMA until FDA takes final
action under section 515(b) of the FD&C Act (21 U.S.C. 360e(b))
requiring premarket approval.
    Although, under the FD&C Act, the manufacturer of class III
preamendments device may respond to the call for PMAs by filing a PMA
or a notice of completion of a product development protocol (PDP), in
practice, the option of filing a notice of completion of a PDP has not
been used. For simplicity, although corresponding requirements for PDPs
remain available to manufacturers in response to a final order under
section 515(b) of the FD&C Act, this document will refer only to the
requirement for the filing and receiving approval of a PMA.
    On July 9, 2012, FDASIA was enacted. Section 608(b) of FDASIA (126
Stat. 1056) amended section 515(b) of the FD&C Act changing the process
for requiring premarket approval for a preamendments class III device
from rulemaking to an administrative order. Prior to the enactment of
FDASIA, FDA published four proposed rules under section 515(b) to
require PMAs for the sorbent hemoperfusion devices for the treatment of
hepatic coma and metabolic disturbances; cranial electrotherapy
stimulator for the treatment of depression, anxiety, and insomnia;
shortwave diathermy for all uses other than the generation of deep heat
within the body tissues for the treatment of selected medical
conditions; and transilluminator for breast evaluation (76 FR 48062,
August 8, 2011; 77 FR 9610, February 17, 2012; 77 FR 39953, July 6,
2012; 75 FR 52294, August 25, 2010). FDA is issuing this proposed
administrative order to comply with the new procedural requirement
created by FDASIA when requiring premarket approval for preamendments
class III devices. Shortwave diathermy for all uses other than the
generation of deep heat within the body tissues for the treatment of
selected medical conditions is not included in this proposed
administrative order due to an approaching panel meeting on the
classification of this device scheduled for April 5, 2013 (77 FR 71195,
November 29, 2012). Because of the level of interest in the
classification of shortwave diathermy for all uses other than the
generation of deep heat within the body tissues for the treatment of
selected medical conditions and because this technology was last
considered by a panel December 13, 1979, FDA is electing to hold the
panel meeting required by sections 513(e) and 515(b) of the FD&C Act
before issuing a proposed order on this device. FDA believes a new
panel meeting will be useful to consider significant new developments
in the technology class III shortwave diathermy devices use since that
time and the large volume of new information on the use of these
devices. In addition, the 1979 Panel's deliberations focused on class
II shortwave diathermy devices that achieve their affect through use of
therapeutic deep heat instead of those class III shortwave diathermy
devices that are the subject of FDA's July 6, 2012, proposed rule.
    Comments submitted in response to the proposed rules on sorbent
hemoperfusion devices for the treatment of hepatic coma and metabolic
disturbances; cranial electrotherapy stimulator for the treatment of
depression, anxiety, and insomnia; and transilluminator for breast
evaluation will be considered under this proposed administrative order
and do not need to be resubmitted. Similarly, FDA continues to review
the merits of the requests for reclassification submitted in response
to the proposed rules. Any preliminary decisions on those requests are
not reflected in this proposed administrative order to require the
filing of a PMA for sorbent hemoperfusion devices for the treatment of
hepatic coma and metabolic disturbances; cranial electrotherapy
stimulator for the treatment of depression, anxiety, and insomnia; and
transilluminator for breast evaluation. This action is intended solely
to fulfill the procedural requirements for reclassification implemented
by FDASIA.
    Section 515(b)(1) of the FD&C Act sets forth the process for
issuing a final administrative order. Specifically, prior to the
issuance of a final order requiring premarket approval for a
preamendments class III device, the following must occur: Publication
of a proposed order in the Federal Register; a meeting of a device
classification panel described in section 513(b) of the FD&C Act; and
consideration of comments from all affected stakeholders, including
patients, payors, and providers. FDA has held a meeting of a device
classification panel described in section 513(b) of the FD&C Act with
respect to cranial electrotherapy stimulator for the treatment of
depression, anxiety, and insomnia and transilluminator for breast
evaluation, and therefore, has met this requirement under section
515(b)(1) of the FD&C Act.
    Section 515(b)(2) of the FD&C Act provides that a proposed order to
require premarket approval shall contain: (1) The proposed order, (2)
proposed findings with respect to the degree of risk of illness or
injury designed to be eliminated or reduced by requiring the device to
have an approved PMA and the benefit to the public from the use of the
device, (3) an opportunity for the submission of comments on the
proposed order and the proposed findings, and (4) an opportunity to
request a change in the classification of the device based on new
information relevant to the classification of the device.
    Section 515(b)(3) of the FD&C Act provides that FDA shall, after
the close of the comment period on the proposed order, consideration of
any comments received, and a meeting of a device classification panel
described in section 513(b) of the FD&C Act, issue a final order to
require premarket approval or publish a document terminating the
proceeding together with the reasons for such termination. If FDA
terminates the proceeding, FDA is required to initiate reclassification
of the device under section 513(e) of the FD&C Act, unless the reason
for termination is that the device is a banned device under section 516
of the FD&C Act (21 U.S.C. 360(f).
    A preamendments class III device may be commercially distributed
without a PMA until 90 days after FDA issues a final order (a final
rule issued under section 515(b) of the FD&C Act prior to the enactment
of FDASIA is considered to be a final order for purposes of section
501(f) of the FD&C Act (21 U.S.C. 351(f))) requiring premarket approval
for the device, or 30 months after final classification of the device
under section 513 of the FD&C Act, whichever is later. For the
preamendments class III devices that are the subject of this proposal,
the later of these two time periods is the 90-day period. Since the
sorbent hemoperfusion devices for the treatment of hepatic coma and
metabolic disturbances; cranial electrotherapy stimulator for the
treatment of depression, anxiety, and insomnia; and transilluminator
for breast evaluation were classified in 1983, 1979, and 1995,
respectively, the 30-month period has

expired (48 FR 53028, November 23, 1983; 44 FR 51770, September 4,
1979; and 60 FR 36639, July 18, 1995, respectively). Therefore, if the
proposal to require premarket approval for sorbent hemoperfusion
devices for the treatment of hepatic coma and metabolic disturbances;
cranial electrotherapy stimulator for the treatment of depression,
anxiety, and insomnia; or transilluminator for breast evaluation is
finalized, section 501(f)(2)(B) of the FD&C Act requires that a PMA for
such device be filed within 90 days of the date of issuance of the
final order. If a PMA is not filed for such device within 90 days after
the issuance of a final order, the device would be deemed adulterated
under section 501(f) of the FD&C Act.
    Also, a preamendments device subject to the order process under
section 515(b) of the FD&C Act is not required to have an approved
investigational device exemption (IDE) (see part 812 (21 CFR part 812))
contemporaneous with its interstate distribution until the date
identified by FDA in the final order requiring the filing of a PMA for
the device. At that time, an IDE is required only if a PMA has not been
filed. If the manufacturer, importer, or other sponsor of the device
submits an IDE application and FDA approves it, the device may be
distributed for investigational use. If a PMA is not filed by the later
of the two dates, and the device is not distributed for investigational
use under an IDE, the device is deemed to be adulterated within the
meaning of section 501(f)(1)(A) of the FD&C Act, and subject to seizure
and condemnation under section 304 of the FD&C Act (21 U.S.C. 334) if
its distribution continues. Other enforcement actions include, but are
not limited to, the following: Shipment of devices in interstate
commerce will be subject to injunction under section 302 of the FD&C
Act (21 U.S.C. 332), and the individuals responsible for such shipment
will be subject to prosecution under section 303 of the FD&C Act (21
U.S.C. 333). In the past, FDA has requested that manufacturers take
action to prevent the further use of devices for which no PMA has been
filed and may determine that such a request is appropriate for the
class III devices that are the subject of this proposed order, if
finalized.
    In accordance with section 515(b)(2) of the FD&C Act, interested
persons are being offered the opportunity to request reclassification
of sorbent hemoperfusion devices for the treatment of hepatic coma and
metabolic disturbances; cranial electrotherapy stimulator for the
treatment of depression, anxiety, and insomnia; and transilluminator
for breast evaluation that are the subject of this proposal. Requests
for reclassification previously submitted in response to the proposed
rules (76 FR 48062, August 8, 2011; 75 FR 52294, August 25, 2010; 77 FR
9610, February 17, 2012) will be considered under this proposed
administrative order and do not need to be resubmitted.
    Along with proposing to require PMAs for sorbent hemoperfusion
devices for the treatment of hepatic coma and metabolic disturbances;
cranial electrotherapy stimulator for the treatment of depression,
anxiety, and insomnia; and transilluminator for breast evaluation, FDA
is also publishing this document to propose the reclassification of
sorbent hemoperfusion devices for the treatment of poisoning and drug
overdose from class III to class II. Section 513(e) of the FD&C Act
governs reclassification of classified preamendments devices. This
section provides that FDA may, by administrative order, reclassify a
device based upon ``new information.'' FDA can initiate a
reclassification under section 513(e) or an interested person may
petition FDA to reclassify a preamendments device. The term ``new
information,'' as used in section 513(e) of the FD&C Act, includes
information developed as a result of a reevaluation of the data before
the Agency when the device was originally classified, as well as
information not presented, not available, or not developed at that
time. (See, e.g., Holland-Rantos Co. v. United States Department of
Health, Education, and Welfare, 587 F.2d 1173, 1174 n.1 (D.C. Cir.
1978); Upjohn v. Finch, 422 F.2d 944 (6th Cir. 1970); Bell v. Goddard,
366 F.2d 177 (7th Cir. 1966).)
    Reevaluation of the data previously before the Agency is an
appropriate basis for subsequent action where the reevaluation is made
in light of newly available authority (see Bell, 366 F.2d at 181;
Ethicon, Inc. v. FDA, 762 F. Supp. 382, 388-91 (D.D.C. 1991)), or in
light of changes in ``medical science'' (Upjohn, 422 F.2d at 951).
Whether data before the Agency are old or new data, the ``new
information'' to support reclassification under section 513(e) must be
``valid scientific evidence,'' as defined in section 513(a)(3) of the
FD&C Act and 21 CFR 860.7(c)(2). (See, e.g., General Medical Co. v.
FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens Association v. FDA,
766 F.2d 592 (D.C. Cir. 1985), cert. denied, 474 U.S. 1062 (1986).)
    FDA relies upon ``valid scientific evidence'' in the classification
process to determine the level of regulation for devices. To be
considered in the reclassification process, the ``valid scientific
evidence'' upon which the Agency relies must be publicly available.
Publicly available information excludes trade secret and/or
confidential commercial information, e.g., the contents of a pending
PMA. (See section 520(c) of the FD&C Act (21 U.S.C. 360j(c)).) Section
520(h)(4) of the FD&C Act (21 U.S.C. 360j(h)(4)), added by FDAMA,
provides that FDA may use, for reclassification of a device, certain
information in a PMA 6 years after the application has been approved.
This includes information from clinical and preclinical tests or
studies that demonstrate the safety or effectiveness of the device but
does not include descriptions of methods of manufacture or product
composition and other trade secrets.
    On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA (126
Stat. 1056) amended section 513(e) of the FD&C Act changing the process
for reclassifying a preamendments class III device from rulemaking to
an administrative order. Prior to the enactment of FDASIA, FDA
published a proposed rule under section 513(e) proposing the
reclassification of sorbent hemoperfusion devices for the treatment of
poisoning and drug overdose. The same device is the subject of this
proposed order so that FDA can comply with the new procedural
requirement created by FDASIA when reclassifying a preamendments class
III device.
    Section 513(e)(1) of the FD&C Act sets forth the process for
issuing a final order. Specifically, prior to the issuance of a final
order reclassifying a device, the following must occur: (1) Publication
of a proposed order in the Federal Register; (2) a meeting of a device
classification panel described in section 513(b) of the FD&C Act; and
(3) consideration of comments to a public docket.
    FDAMA added section 510(m) to the FD&C Act. Section 510(m) of the
FD&C Act provides that a class II device may be exempted from the
premarket notification requirements under section 510(k) of the FD&C
Act, if the Agency determines that premarket notification is not
necessary to assure the safety and effectiveness of the device.

II. Dates New Requirements Apply

    In accordance with section 515(b) of the FD&C Act, FDA is proposing
to require that a PMA be filed with the Agency for three preamendments
class III devices, sorbent hemoperfusion devices for the treatment of
hepatic coma and metabolic disturbances; cranial electrotherapy
stimulator for the

treatment of depression, anxiety, and insomnia; and transilluminator
for breast evaluation, within 90 days after issuance of any final order
based on this proposal. An applicant whose device was legally in
commercial distribution before May 28, 1976, or whose device has been
found to be substantially equivalent to such a device, will be
permitted to continue marketing such class III device during FDA's
review of the PMA provided that the PMA is timely filed. FDA intends to
review any PMA for the device within 180 days of the date of filing.
FDA cautions that under section 515(d)(1)(B)(i) of the FD&C Act, the
Agency may not enter into an agreement to extend the review period for
a PMA beyond 180 days unless the Agency finds that ``the continued
availability of the device is necessary for the public health.''
    FDA intends that under Sec.  812.2(d), the publication in the
Federal Register of any final order based on this proposal will include
a statement that, as of the date on which a PMA is required to be
filed, the exemptions from the requirements of the IDE regulations for
preamendments class III devices in Sec.  812.2(c)(1) and (c)(2) will
cease to apply to any device that is: (1) Not legally on the market on
or before that date or (2) legally on the market on or before that date
but for which a PMA is not filed by that date, or for which PMA
approval has been denied or withdrawn.
    If a PMA for a class III device is not filed with FDA within 90
days after the date of issuance of any final order requiring premarket
approval for the device, the device would be deemed adulterated under
section 501(f) of the FD&C Act. The device may be distributed for
investigational use only if the requirements of the IDE regulations are
met. The requirements for significant risk devices include submitting
an IDE application to FDA for review and approval. An approved IDE is
required to be in effect before an investigation of the device may be
initiated or continued under Sec.  812.30. FDA, therefore, recommends
that IDE applications be submitted to FDA at least 30 days before the
end of the 90-day period after the issuance of the final order to avoid
interrupting any ongoing investigations.
    Because sorbent hemoperfusion devices for the treatment of
poisoning and drug overdose can currently be marketed after receiving
clearance of an application for premarket notification and FDA is
proposing to reclassify these devices as class II requiring clearance
of an application for premarket notification, this order, if finalized,
will not impose any new requirements on sorbent hemoperfusion devices
for the treatment of poisoning and drug overdose.

III. Proposed Findings With Respect to Risks and Benefits for Devices
Subject to the Proposal To Require PMA

    As required by section 515(b) of the FD&C Act, FDA is publishing
its proposed findings regarding: (1) The degree of risk of illness or
injury designed to be eliminated or reduced by requiring that these
devices have an approved PMA and (2) the benefits to the public from
the use of the devices.
    These findings are based on the reports and recommendations of the
advisory committee (panel) for the classification of these devices
along with information submitted in response to the 515(i) Order (74 FR
16214, April 9, 2009), and any additional information that FDA has
obtained. Additional information regarding the risks as well as
classification associated with these device types can be found in the
following proposed and final rules and notices published in the Federal
Register: Cranial electrotherapy stimulator for the treatment of
depression, anxiety, and insomnia, 43 FR 55716 (November 28, 1974), 44
FR 51770 (September 4, 1979), 54 FR 550 (January 6, 1989), 58 FR 45865
(August 31, 1993), 60 FR 43967 (August 24, 1995), 61 FR 59448 (November
22, 1996), 62 FR 4023 (January 28, 1997), 62 FR 30456 and 62 FR 30600
(June 4, 1997), and 76 FR 48062 (August 8, 2011); classification of
transilluminators (Diaphanoscopes or Lightscanners) for breast
evaluation, 60 FR 3168 (January 13, 1995), 60 FR 36639 (July 18, 1995),
and 75 FR 52294, (August 25, 2010); and sorbent hemoperfusion for the
treatment of hepatic coma and metabolic disturbances (46 FR 7630, 46 FR
7562, and 48 FR 53023).
    The proposed findings concerning the degree of risk of illness or
injury for each of these devices is set out in section IV, as well as
information concerning known benefits, if any for these devices. FDA
notes, however, that there is limited scientific evidence regarding the
effectiveness of the sorbent hemoperfusion devices for the treatment of
hepatic coma and metabolic disturbances; cranial electrotherapy
stimulator for the treatment of depression, anxiety, and insomnia; and
transilluminator for breast evaluation devices. Because the benefits of
these devices for the indications specified are unknown, it is
impossible to estimate the direct effect of the devices on patient
outcomes. However, claims for the devices state the devices have the
potential to benefit the public in the following ways:
     Cranial electrotherapy stimulator for the treatment of
depression, anxiety, and insomnia. CES devices are marketed as a
treatment for insomnia, anxiety, or depression (either symptoms thereof
or the underlying disorder).
     Sorbent hemoperfusion devices for the treatment of hepatic
coma and metabolic disturbances. Disorders that affect the liver can
result in metabolic disturbances and a decrease in brain function due
to the accumulation of toxins in the blood. This reduced brain function
may eventually result in hepatic coma and death. Sorbent hemoperfusion
systems are marketed as a treatment device to compensate for liver
failure by removing toxins from the blood.
     Transilluminator for breast evaluation. Transilluminator
for breast evaluation is marketed as an aid in breast self examination
as an addition to normal breast health routine by visualizing
translucent tissue for the diagnosis of cancer, other conditions,
diseases, or abnormalities.

IV. Devices Subject to the Proposal To Require PMA

A. Sorbent Hemoperfusion System for the Treatment of Hepatic Coma and
Metabolic Disturbances (21 CFR 876.5870(c))

1. Identification
    A sorbent hemoperfusion system is a device that consists of an
extracorporeal blood system and a container filled with adsorbent
material that removes a wide range of substances, both toxic and
normal, from blood flowing through it. The adsorbent materials are
usually activated-carbon or resins, which may be coated or immobilized
to prevent fine particles entering the patient's blood. The generic
type of device may include lines and filters specifically designed to
connect the device to the extracorporeal blood system. Sorbent
hemoperfusion systems may also include the machine or instrument used
to drive and manage blood and fluid flow within the extracorporeal
circuit, as well as any accompanying controllers, monitors, or sensors.
2. Summary of Data
    For the treatment of hepatic coma and metabolic disturbances, FDA
concludes that the safety and effectiveness of these devices have not
been established by adequate scientific evidence, and the Agency
continues to agree with the Gastroenterology-Urology Device Panel's
recommendation. The review of the published scientific literature

revealed mostly observational studies performed with sorbent
hemoperfusion devices. Only a few randomized, controlled trials were
found, but sample sizes were small and not adequately powered, and
etiologies and control group criteria were varied. Furthermore, based
on FDA's experience reviewing these devices for use in the treatment of
hepatic coma and metabolic disturbances, bench testing is not adequate
in establishing the devices' safety and effectiveness, particularly
since characterizing a sorbent hemoperfusion system's performance and
adsorption capabilities has not correlated to patient outcomes, such as
resolution of the patients' hepatic coma, or improvements in mortality.
The scientific literature also revealed that there is no consensus on
the clinical endpoints necessary to adequately evaluate sorbent
hemoperfusion devices for the treatment of hepatic coma and metabolic
disturbances or on the patient populations who will benefit the most
from the use of these devices.
3. Risks to Health
     Extracorporeal leaks (blood loss)--Rupture of the
extracorporeal circuit, cartridge, filters, and/or tubing, as well as
disconnections, may lead to blood leaks and blood loss.
     Platelet loss and thrombocytopenia--The adsorption
characteristics of the device may cause large losses of platelets
during hemoperfusion.
     Leukopenia--The materials used, or the design of the
device, may cause absorption of leukocytes, leading to the transient
loss of leukocytes in a patient.
     Hemolysis--The materials used, or the design of the blood
pathways in the device, may cause the lysis of red blood cells.
     Leak of adsorbent agent into fluid path (release of
emboli)--Fine particles leached from the sorbent column of the device
may be deposited in the arterioles of the lungs and other organ as
particulate emboli.
     Lack of sterility--Improper sterilization or compromise of
the device packaging may lead to the introduction of microorganisms,
which may be transmitted to a patient during use.
     Toxic and/or pyrogenic reactions--Toxic substances may be
leached from the device, causing a patient to have a pyrogenic reaction
(sudden fever with collapse and chills).
     Infection--Defects in the design or construction of the
device preventing adequate cleaning and/or sterilization may allow
pathogenic organisms to be introduced and may cause an infection in a
patient.
     Hypotension--Sudden fluid shifts within the patient, due
to pressures exerted by the device, or to fluid being removed by the
device, may cause sudden decreases in a patient's blood pressure.
     Lack of biocompatibility in materials or solutions
contacting blood--The patient-contacting materials of the device may
cause an adverse immunological or allergic reaction in a patient.
     Clotting (blood loss)--The materials used, or the design
of the device, may cause a patient's blood to form clots, which may
obstruct the device's extracorporeal circuit, interrupting or
terminating treatments, and also leading to blood loss, because the
blood entrapped in the clotted blood circuit often cannot be returned
to the patient.
     Removal or depletion of vital nutrients, hormones,
vitamins, substances. and drugs (e.g., adsorption of glucose,
unspecific removal characteristics, drop in patients' hematocrit), due
to device's lack of specificity--The adsorption characteristics of the
device may cause removal or depletions of nutrients, hormones, and
other necessary substances.
     Metabolic disturbances--The removal of normal metabolites
along with undesirable substances may lead to metabolic disturbances.
     Lack of effectiveness--The adsorption characteristics of
the device may lead to the failure to remove drugs in the treatment of
poisoning or drug overdose, or to bring on clinical improvement in
hepatic coma and metabolic disturbances.
     Treatment interruptions or discontinuations--Inadequate
safeguards in the device may lead to treatment interruptions or
discontinuations in the case of power failures.
     Electrical shock due to lack of electrical safety--
Inadequate safeguards in the device may lead to electrical shocks in
patients using them.
     Electromagnetic interference, which may lead to adverse
interactions with other patient systems--Inadequate safeguards in the
device may lead to its interference with other patient systems, causing
adverse events in the patient, as well as adversely affecting the
performance of the other patient systems.

B. Cranial Electrotherapy Stimulator (21 CFR 882.5800)

1. Identification
    A cranial electrotheraphy stimulator is a device that applies
electrical current to a patient's head to treat depression, anxiety, or
insomnia.
2. Summary of Data
    The Neurological Devices Panel that discussed original
classification for the cranial electrotherapy stimulator (CES) device
in 1977 and 1978 ultimately recommended that the device be classified
into class III because satisfactory device effectiveness had not been
demonstrated. The panel considered information from the National
Research Council, which reviewed 88 published studies on CES and
concluded that the device has not been shown to be effective in
treating any of the conditions for which it was prescribed. In
addition, the panel indicated that it was not possible to establish an
adequate performance standard for CES because the characteristics of
the electrical current necessary for potential effectiveness were not
known. The panel believed that general controls would not provide
sufficient control over these characteristics, and that the device
presented a potential unreasonable risk of illness or injury to the
patient if the practitioner relied on the device, and it was
ineffective in treating the patient's illness. Therefore, the panel
recommended that premarket approval was necessary to assure the safety
and effectiveness of CES devices.
    In support of a subsequent proposed rule in 1993 for classification
of CES into class III, FDA performed a literature review and identified
additional studies that had been performed for CES. After a review of
the scientific literature, FDA concluded that the effectiveness of CES
had still not been established by adequate scientific evidence. While
this rule was finalized in 1995 (60 FR 43969), it was withdrawn in 1997
(62 FR 30456). FDA performed additional literature searches for studies
of CES published after the 1993 proposed rule in support of the
proposed rule to retain CES devices in class III and a call for PMAs
issued on August 8, 2011 (76 FR 48062), as well as in preparation for
the panel meeting described in the paragraphs that follow.
    FDA received three petitions requesting a change in the
classification of CES devices in response to the August 8, 2011,
proposed rule (76 FR 48062). FDA received a petition from
Electromedical Products International, Inc., dated August 19, 2011
[FDA-2011-

N-0504-0029], requesting the Agency to reclassify from class III into
class II the CES for the ``treatment of insomnia, depression, or
anxiety.'' FDA received petitions from Fisher Wallace Laboratories,
LLC, dated August 22, 2011 [FDA-2011-N-0504-0031], and Neuro-Fitness
LLC, dated August 22, 2011 [FDA-2011-N-0504-0033], both requesting the
Agency to reclassify from class III into class II the CES for the
``treatment of depression, anxiety, and insomnia in adult substance
abuse patients who have failed to achieve satisfactory improvement from
one prior antidepressant or sleep medication at or above the minimal
effective dose and duration in the current episode, or are unable to
tolerate such medication.'' The petition from Neuro-Fitness also
mentioned ``general treatment of anxiety, depression, and insomnia as
part of an approved program of medical care when conventional
approaches have failed or are deemed inappropriate'' and ``treatment of
the primary symptoms of substance abuse: Anxiety, depression, and
insomnia when conventional approaches have failed or are deemed
inappropriate.'' FDA continues to review the merits of the previous
requests for reclassification submitted in response to the proposed
rules and any preliminary decisions on those requests are not reflected
in this proposed administrative order proposing to require the filing
of a PMA for the cranial electrotherapy stimulator device for the
treatment of depression, anxiety, and insomnia.
    Consistent with then-section 515(b)(2)(B) of the FD&C Act as it
stood at the time and 21 CFR 860.125, FDA referred the petitions to the
Panel for its recommendation on the requested change in classification
in February 2012. FDA provided the panel members with the three
reclassification petitions and FDA's executive summary (Ref. 1). Based
on its review of the data and information as well as information
presented during its February 10, 2012, open meeting (Ref. 2), the
Neurological Devices Panel recommended that the CES device for
treatment of insomnia, depression, and anxiety should remain in class
III requiring PMAs. The Panel consensus was that there was not adequate
scientific evidence to provide a reasonable assurance of effectiveness
for the CES device for any of the indications proposed by the
petitioners. Although the panel expressed some reservations regarding
several of the risks that FDA had identified as being associated with
CES, the Panel consensus was that given the lack of adequate
effectiveness data, the probable benefits of the CES device did not
outweigh the probable risks. The Panel also suggested that the list of
risks in the proposed rule was not accurate. While there was consensus
for including the risks of skin irritation, headaches, and dizziness,
the panel did not agree that seizures and blurred vision were risks
associated with CES as it is characterized today by the devices on the
market and the comparable devices studied in clinical trials. The Panel
also suggested that worsening of the condition being treated, though a
risk, could be adequately addressed through patient supervision by a
medical professional.
    While the panel did not recommend a classification for the focused
indication in the substance abuse population for which two petitioners
requested class II, the panel concluded that the substance abuse
population did adequately define a target population and that there
were no significant additional risks associated with use of the device
in the substance abuse population as compared to the population of
patients who are not substance abusers. The panel also recommended
there was not adequate scientific evidence to provide a reasonable
assurance of effectiveness for the CES device for treatment of
insomnia, depression, or anxiety in the substance abuse population.
3. Risks to Health
     Worsening of the condition being treated--If the device is
not effective and the patient is not treated in a conventional manner,
the patient's psychological condition may worsen.
     Skin irritation--The electrodes or the conductive cream
used with the electrodes may cause skin irritation.
     Headaches--Reported cases of adverse effects of CES
devices include headaches following treatment with electrical
stimulation.
     Potential adverse effects from electrical stimulation of
the brain--The physiological effects associated with electrical
stimulation of the brain by these devices have not been studied
systematically; therefore, adverse effects which may be caused by these
electrical stimuli remain unknown.

C. Transilluminator for Breast Evaluation (21 CFR 892.1990)

1. Identification
    A transilluminator, also known as a diaphanoscope or lightscanner,
is an electrically powered device that uses low intensity emissions of
visible light and near-infrared radiation (approximately 700-1050
nanometers (nm)), transmitted through the breast, to visualize
translucent tissue for the diagnosis of cancer, other conditions,
diseases, or abnormalities.
2. Summary of Data
    On January 11, 1991, the Obstetrics and Gynecology Devices Panel
recommended that transilluminator devices for breast evaluation be
classified into class III and subject to premarket approval to provide
reasonable assurance of the safety and effectiveness of the device. The
panel concluded that there were no published studies or clinical data
demonstrating the safety and effectiveness of the device. The panel
indicated that the device presents a potential unreasonable risk of
illness or injury to the patient if the clinician relies on the device
and that although the device's illumination level, wavelength, and
image quality can be controlled through tests and specifications,
insufficient evidence exists to determine that special controls can be
established to provide reasonable assurance of the safety and
effectiveness of the device for its intended use.
    In addition, the Radiologic Devices Panel considered the
classification of the device on April 12, 2012 (Ref. 3), and expressed
concerns regarding the effectiveness of the device which may result in
delayed diagnosis and determined that general controls and special
controls are not sufficient to provide a reasonable assurance of safety
and effectiveness of the device for the diagnosis of cancer, other
conditions, diseases, or abnormalities. Accordingly, the panel
concluded that the device should remain in class III. FDA agreed and
continues to agree with the recommendations of both panels and is aware
of no information submitted in response to the 515(i) Order (74 FR
16214, April 9, 2009) or otherwise available to FDA that would support
a different classification. The Agency notes that the device has fallen
into disuse and that the published data are not adequate to demonstrate
the safety and effectiveness of the device.
3. Risks to Health
    a. Missed or delayed diagnosis--As a result of the questionable
device performance of breast transilluminators, missed or delayed
diagnosis are the most catastrophic risks to health for a woman. These
devices depend on the users' visual interpretation of their own breast
illumination. One scenario may result when a woman incorrectly
interprets her transillumination as a tumor and suffers the ensuing
anxiety from her belief that she has a cancer. Another scenario may
result when a

woman incorrectly dismisses the findings of her transillumination and
then suffers from a missed diagnosis or delayed diagnosis and delayed
treatment. Ultimately, missed or delayed diagnoses could result in the
need for more aggressive treatment and a potentially higher risk of
death.
    b. Electrical shock--If a breast transilluminator is not designed
properly, the user may receive an electrical shock.
    c. Optical radiation--Prolonged gazing directly into the light of a
breast illuminator while engaged in ``bright light mode'' may result in
retinal damage.

V. PMA Requirements

    A PMA for sorbent hemoperfusion devices for the treatment of
hepatic coma and metabolic disturbances; cranial electrotherapy
stimulator for the treatment of depression, anxiety, or insomnia; and
transilluminator for breast evaluation must include the information
required by section 515(c)(1) of the FD&C Act. Such a PMA should also
include a detailed discussion of the risks identified previously, as
well as a discussion of the effectiveness of the device for which
premarket approval is sought. In addition, a PMA must include all data
and information on: (1) Any risks known, or that should be reasonably
known, to the applicant that have not been identified in this document;
(2) the effectiveness of the device that is the subject of the
application; and (3) full reports of all preclinical and clinical
information from investigations on the safety and effectiveness of the
device for which premarket approval is sought.
    A PMA must include valid scientific evidence to demonstrate
reasonable assurance of the safety and effectiveness of the device for
its intended use (see Sec.  860.7(c)(1) (21 CFR 860.7(c)(1))). Valid
scientific evidence is ``evidence from well-controlled investigations,
partially controlled studies, studies and objective trials without
matched controls, well-documented case histories conducted by qualified
experts, and reports of significant human experience with a marketed
device, from which it can fairly and responsibly be concluded by
qualified experts that there is reasonable assurance of the safety and
effectiveness of a device under its conditions of use * * * Isolated
case reports, random experience, reports lacking sufficient details to
permit scientific evaluation, and unsubstantiated opinions are not
regarded as valid scientific evidence to show safety or
effectiveness.'' (see Sec.  860.7(c)(2)).

VI. Opportunity To Request a Change in Classification

    Before requiring the filing of a PMA for a device, FDA is required
by section 515(b)(2)(D) of the FD&C Act to provide an opportunity for
interested persons to request a change in the classification of the
device based on new information relevant to the classification. Any
proceeding to reclassify the device will be under the authority of
section 513(e) of the FD&C Act.
    A request for a change in the classification of sorbent
hemoperfusion devices for the treatment of hepatic coma and metabolic
disturbances; cranial electrotherapy stimulator for the treatment of
depression, anxiety, and insomnia; and transilluminator for breast
evaluation devices is to be in the form of a reclassification petition
containing the information required by 21 CFR 860.123, including new
information relevant to the classification of the device.
    Requests for reclassification submitted in response to the proposed
rules will be considered under this proposed administrative order and
do not need to be resubmitted. FDA continues to review the merits of
the previous requests for reclassification submitted in response to the
proposed rules and any preliminary decisions on those requests are not
reflected in this proposed administrative order proposing to require
the filing of a PMA for sorbent hemoperfusion devices for the treatment
of hepatic coma and metabolic disturbances; cranial electrotherapy
stimulator for the treatment of depression, anxiety, and insomnia; and
transilluminator for breast evaluation.

VII. Proposed Reclassification

    FDA is proposing that sorbent hemoperfusion systems intended for
the treatment of poisoning and drug overdose be reclassified from class
III to class II. FDA is also proposing to create a separate
classification for these devices to differentiate them from sorbent
hemoperfusion systems for the treatment of hepatic coma and metabolic
disturbances. FDA believes sorbent hemoperfusion devices for the
treatment of poisoning and drug overdose can be useful in the treatment
of emergent poisoning and drug overdose events by reducing the level of
related toxic substances in the bloodstream, thereby reducing or
preventing damage to the liver and resultant negative patient outcomes.
    FDA has considered sorbent hemoperfusion systems intended for the
treatment of poisoning and drug overdose in accordance with the
reserved criteria and determined that these devices require premarket
notification. The Agency does not intend to exempt this proposed class
II device from premarket notification (510(k)) submission as provided
for under section 510(m) of the FD&C Act.

VIII. Summary of Reasons for Reclassification

    FDA believes that sorbent hemoperfusion systems intended for the
treatment of poisoning and drug overdose should be reclassified into
class II because special controls, in addition to general controls, are
necessary to provide reasonable assurance of the safety and
effectiveness of the device. In addition, there is now sufficient
information to establish special controls to provide such assurance.

IX. Summary of Data Upon Which the Reclassification is Based

    FDA believes that the identified special controls, in addition to
general controls, are necessary to provide reasonable assurance of
safety and effectiveness. Therefore, in accordance with sections 513(e)
and 515(i) of the FD&C Act and 21 CFR 860.130, based on new information
with respect to the device, FDA, on its own initiative, is proposing to
reclassify this preamendments class III device intended for the
treatment of poisoning and drug overdose into class II. The Agency has
identified special controls that would provide reasonable assurance of
their safety and effectiveness. Sorbent hemoperfusion systems intended
for the treatment of poisoning and drug overdose are prescription
devices restricted to patient use only upon the authorization of a
practitioner licensed by law to administer or use the device. (Proposed
Sec.  876.5870(a); see section 520(e) of the FD&C Act and 21 CFR
801.109 (Prescription devices)). Prescription-use restrictions are a
type of general controls authorized under section 520(e) and defined as
a general control in section 513(a)(1)(A)(i) of the FD&C Act.
    Sorbent hemoperfusion is used in a small number of poisoning and
drug overdose cases each year. Due to the emergent nature of poisoning
and drug overdose events, it is expected that the published clinical
literature is limited and that randomized, controlled, clinical trials
are not practical to conduct. Since the time of the original
Gastroenterology-Urology Device Classification Panel recommendation in
1981, sufficient new evidence has been developed to support a
reclassification

of sorbent hemoperfusion system to class II with special controls for
the treatment of poisoning and hepatic coma. There is valid scientific
evidence which demonstrate that these devices are of clinical value in
treating poisoning and drug overdose patients (Refs. 4 to 11). In this
patient population, which is often relatively healthy prior to the
poisoning or overdose event, quick removal of the poison or drug can
greatly impact clinical outcomes, whereas in the hepatic coma and
encephalopathy population, which typically exhibit severe underlying
disease, comorbidities, and high mortality there is no substantive
evidence on what substances need to be removed or decreased to bring on
patient improvements or change clinical outcomes.
    Unlike sorbent hemoperfusion devices for the treatment of hepatic
coma and metabolic disturbances, appropriate bench testing
methodologies have also been developed to provide assurance that the
device can remove a particular poison or drug from the bloodstream. FDA
has developed sufficient confidence in these bench tests via review of
510(k) submissions for these devices. In addition, a review of the
available literature, FDA's MAUDE adverse event reporting database, and
the manufacturer's submission to the 515(i) docket (74 FR 16214, April
9, 2009) did not present evidence of significant reports of adverse
events associated with the use of the sorbent hemoperfusion despite the
longstanding use of these devices.
    Given the low occurrence of adverse events, the valid scientific
evidence to support sorbent hemoperfusion for this use, and FDA's
review experience with these devices, FDA believes that the identified
special controls, including performance testing to ensure that the
device is effective in removing particular poisons or drugs and is
adequately designed and includes adequate safeguards, and labeling to
inform users of inappropriate use conditions, in addition to general
controls, provide reasonable assurance of effectiveness for this device
for the treatment of poisoning and drug overdose.

X. Environmental Impact

    The Agency has determined under 21 CFR 25.30(h) and 25.34(b) that
this action is of a type that does not individually or cumulatively
have a significant effect on the human environment. Therefore, neither
an environmental assessment nor an environmental impact statement is
required.

XI. Paperwork Reduction Act of 1995

    This proposed order refers to collections of information that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
    The collections of information in 21 CFR part 814 have been
approved under OMB control number 0910-0231. The collections of
information in 21 CFR part 807, subpart E, have been approved under OMB
control number 0910-0120. The effect of this order, if finalized, is to
shift certain devices from the 510(k) premarket notification process to
the PMA process. To account for this change, FDA intends to transfer
some of the burden from OMB control number 0910-0120, which is the
control number for the 510(k) premarket notification process, to OMB
control number 0910-0231, which is the control number for the PMA
process. FDA estimates that it will receive 16 new PMAs as a result of
this order, if finalized. Based on FDA's most recent estimates, this
will result in a 4,842 hour burden increase. FDA also estimates that
there will be 14 fewer 510(k) submissions as a result of this order, if
finalized, because two manufacturers have not introduced their device
to market yet. Based on FDA's most recent estimates, this will result
in a 726 hour burden decrease. Therefore, on net, FDA expects a burden
hour increase of 4,116 due to this proposed regulatory change.
    The collections of information in part 812 have been approved under
OMB control number 0910-0078.

XII. Codification of Orders

    Prior to the amendments by FDASIA, section 513(e) of the FD&C Act
provided for FDA to issue regulations to reclassify devices and section
515(b) of the FD&C Act provided for FDA to issue regulations to require
approval of an application for premarket approval for preamendments
devices or devices found to be substantially equivalent to
preamendments devices. Because sections 513(e) and 515(b) as amended
require FDA to issue final orders rather than regulations, FDA will
continue to codify reclassifications and requirements for approval of
an application for premarket approval, resulting from changes issued in
final orders, in the Code of Federal Regulations. Therefore, under
section 513(e)(1)(A)(i) of the FD&C Act, as amended by FDASIA, in this
proposed order, we are proposing to revoke the requirements in 21 CFR
876.5870 related to the classification of sorbent hemoperfusion devices
for the treatment of poisoning and drug overdose as class III devices
and to codify the reclassification of sorbent hemoperfusion devices for
the treatment of poisoning and drug overdose into class II.

XIII. Proposed Effective Date

    FDA is proposing that any final order based on this proposed order
become effective 90 days after date of publication of the final order
in the Federal Register.

XIV. Comments

    Comments submitted to the previous dockets for the relevant devices
(cranial electrotherapy stimulator for the treatment of depression,
anxiety, and insomnia FDA-2011-N-0504; transilluminator for breast
evaluation FDA-2010-N-0412; sorbent hemoperfusion devices to treat
hepatic coma and metabolic disturbances; and sorbent hemoperfusion
devices for the treatment FDA-2012-M-0076) have been officially noted
and do not need to be resubmitted. FDA will consider previous docket
comments in issuing any final orders for these devices. Interested
persons may submit either written comments regarding this document to
the Division of Dockets Management (see ADDRESSES) or electronic
comments to http://www.regulations.gov. It is only necessary to send
one set of comments. Identify comments with the docket number found in
brackets in the heading of this document. Received comments may be seen
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at http://www.regulations.gov.

XV. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES), and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at http://www.regulations.gov. (FDA
has verified the Web site addresses, but we are not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.)

1. FDA Executive Summary prepared for the February 10, 2012, meeting
of the Neurologic Devices Panel--Petitions to Request Change in
Classification for Cranial Electrotherapy Stimulators.
2. Transcript, Center for Devices and Radiological Health Medical
Devices Advisory Committee, Neurological

Devices Panel, February 10, 2012, 8 a.m., Hilton Washington DC
North, 620 Perry Pkwy., Gaithersburg, MD. Available at http://www.fda.gov/AdvisoryCommittees/Calendar/ucm279941.htm.
3. Transcript, Center for Devices and Radiological Health Medical
Devices Advisory Committee, Radiological Devices Panel, April 12,
2012, 8 a.m., Hilton Washington DC North, 620 Perry Pkwy.,
Gaithersburg, MD. Available at http://www.fda.gov/AdvisoryCommittees/Calendar/ucm293275.htm.
4. Evenepoel, P., et al., ``Detoxifying Capacity and Kinetics of the
Molecular Adsorbent Recycling System, Contribution of the Different
Inbuilt Filters.'' Blood Purification, 21(3): p. 244-52, 2003.
5. Ash, S. R., et al., ``Treatment of Acetaminophen-Induced
Hepatitis and Fulminant Hepatic Failure With Extracorporeal Sorbent-
Based Devices,'' Advances in Renal Replacement Therapy, 9(1): p. 42-
53, 2002.
6. Akdogan, M., et al., ``Experience With Liver Dialysis in
Acetaminophen Induced Fulminant Hepatic Failure: A Preliminary
Report,'' Turkish Journal of Gastroenterology, 14(3): p. 164-7,
2003.
7. Ash, S. R., et al., ``Treatment of Severe Tricyclic
Antidepressant Overdose With Extracorporeal Sorbent
Detoxification.'' Advances in Renal Replacement Therapy, 9(1): p.
31-41, 2002.
8. De Schoenmakere, G., et al., ``Phenytoin Intoxication in
Critically Ill Patients,'' American Journal of Kidney Diseases,
45(1): p. 189-92, 2005.
9. Covic, A., et al., ``Successful Use of Molecular Absorbent
Regenerating System (MARS) Dialysis for the Treatment of Fulminant
Hepatic Failure in Children Accidentally Poisoned by Toxic Mushroom
Ingestion,'' Liver International, 23 Suppl 3: p. 21-7, 2003.
10. Shi, Y., et al., ``MARS: Optimistic Therapy Method in Fulminant
Hepatic Failure Secondary to Cytotoxic Mushroom Poisoning--A Case
Report,'' Liver, 22 Suppl 2: p. 78-80, 2002.
11. Wu, B .F. and M. M. Wang, Molecular Adsorbent Recirculating
System In Dealing With Maternal Amanita Poisoning During the Second
Pregnancy Trimester: A Case Report, Hepatobiliary and Pancreatic
Diseases International, 3(1): p. 152-4, 2004.

List of Subjects

21 CFR Part 876

    Medical devices.

21 CFR Part 882

    Medical devices, Neurological devices.

21 CFR Part 892

    Medical devices, Radiation protection, X-rays.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR parts 876, 882, and 892 be amended as follows:

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

0
1. The authority citation for 21 CFR part 876 continues to read as
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Section 876.5870 is revised to read as follows:

Sec.  876.5870  Sorbent hemoperfusion system.

    (a) Identification. A sorbent hemoperfusion system is a
prescription device that consists of an extracorporeal blood system
similar to that identified in the hemodialysis system and accessories
(Sec.  876.5820) and a container filled with adsorbent material that
removes a wide range of substances, both toxic and normal, from blood
flowing through it. The adsorbent materials are usually activated-
carbon or resins which may be coated or immobilized to prevent fine
particles entering the patient's blood. The generic type of device may
include lines and filters specifically designed to connect the device
to the extracorporeal blood system. The device is used in the treatment
of poisoning, drug overdose, hepatic coma, or metabolic disturbances.
    (b) Classification. (1) Class II (special controls) when the device
is intended for the treatment of poisoning and drug overdose. The
special controls for this device are:
    (i) The device must be demonstrated to be biocompatible;
    (ii) Performance data to demonstrate the mechanical integrity of
the device (e.g., tensile, flexural, and structural strength),
including testing for the possibility of leaks, ruptures, release of
particles, and/or disconnections;
    (iii) Performance data to demonstrate device sterility and shelf
life;
    (iv) Bench performance data to demonstrate device functionality in
terms of substances, toxins, and drugs removed by the device, and the
extent that these are removed when the device is used according to its
labeling, and to validate the device's safeguards;
    (v) Summary of clinical experience with the device that discusses
and analyzes device safety and performance, including a list of adverse
events observed during the testing;
    (vi) Labeling controls, including appropriate warnings,
precautions, cautions, and contraindications statements to alert and
inform users of proper device use and potential clinical adverse
effects, including blood loss, platelet loss, leukopenia, hemolysis,
hypotension, clotting, metabolic disturbances, and loss of vital
nutrients and substances; labeling recommendations must be consistent
with the performance data obtained for the device, and must include a
list of the drugs and/or poisons the device has been demonstrated to
remove, and the extent for removal/depletion; and
    (vii) For those devices that incorporate electrical components,
appropriate analysis and testing to validate electrical safety and
electromagnetic compatibility.
    (2) Class III (premarket approval) when the device is intended for
the treatment of hepatic coma and metabolic disturbances.
    (c) Date premarket approval application (PMA) or notice of
completion of product development protocol (PDP) is required. A PMA or
notice of completion of a PDP is required to be filed with FDA by [DATE
90 DAYS AFTER DATE OF PUBLICATION OF THE FINAL ORDER IN THE FEDERAL
REGISTER], for any sorbent hemoperfusion system indicated for treatment
of hepatic coma or metabolic disturbances that was in commercial
distribution before May 28, 1976, or that has, by [DATE 90 DAYS AFTER
DATE OF PUBLICATION OF THE FINAL ORDER IN THE FEDERAL REGISTER], been
found to be substantially equivalent to any sorbent hemoperfusion
device indicated for treatment of hepatic coma or metabolic
disturbances that was in commercial distribution before May 28, 1976.
Any other sorbent hemoperfusion system device indicated for treatment
of hepatic coma or metabolic disturbances shall have an approved PMA or
declared completed PDP in effect before being placed in commercial
distribution.

PART 882--NEUROLOGICAL DEVICES

0
3. The authority citation for 21 CFR part 882 continues to read as
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
4. Section 882.5800 is amended by revising paragraph (c) to read as
follows:

Sec.  882.5800  Cranial electrotherapy stimulator.

* * * * *
    (c) Date PMA or notice of completion of PDP is required. A PMA or
notice of completion of a PDP is required to be filed with the Food and
Drug Administration by [A DATE WILL BE ADDED 90 DAYS AFTER DATE OF
PUBLICATION OF A FUTURE FINAL ORDER IN THE FEDERAL REGISTER],

for any cranial electrotherapy stimulator device that was in commercial
distribution before May 28, 1976, or that has, by [A DATE WILL BE ADDED
90 DAYS AFTER DATE OF PUBLICATION OF A FUTURE FINAL ORDER IN THE
FEDERAL REGISTER], been found to be substantially equivalent to any
cranial electrotherapy stimulator device that was in commercial
distribution before May 28, 1976. Any other cranial electrotherapy
stimulator device shall have an approved PMA or declared completed PDP
in effect before being placed in commercial distribution.

PART 892--RADIOLOGY DEVICES

0
5. The authority citation for 21 CFR part 892 continues to read as
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
6. Section 892.1990 is amended by revising paragraph (c) to read as
follows:

Sec.  892.1990  Transilluminator for breast evaluation.

* * * * *
    (c) Date PMA or notice of completion of PDP is required. A PMA or
notice of completion of a PDP is required to be filed with the Food and
Drug Administration by [A DATE WILL BE ADDED 90 DAYS AFTER DATE OF
PUBLICATION OF A FUTURE FINAL ORDER IN THE FEDERAL REGISTER], for any
transilluminator for breast evaluation that was in commercial
distribution before May 28, 1976, or that has, by [A DATE WILL BE ADDED
90 DAYS AFTER DATE OF PUBLICATION OF A FUTURE FINAL ORDER IN THE
FEDERAL REGISTER], been found to be substantially equivalent to any
transilluminator for breast evaluation that was in commercial
distribution before May 28, 1976. Any other transilluminator for breast
evaluation shall have an approved PMA or declared completed PDP in
effect before being placed in commercial distribution.

    Dated: March 29, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2013-07730 Filed 4-3-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 84, Number 91 (Friday, May 10, 2019)]
[Notices]
[Pages 20665-20668]
[FR Doc No: 2019-09629]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85783; File No. SR-EMERALD-2019-19]

Self-Regulatory Organizations; MIAX Emerald, LLC; Notice of
Filing of a Proposed Rule Change To Amend Exchange Rule 515A Concerning
the PRIME Price Improvement and Solicitation Mechanisms and Rules 516
and 517 Regarding Post-Only Orders and Post-Only Quotes

May 6, 2019.
    Pursuant to the provisions of Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice
is hereby given that on April 29, 2019, MIAX Emerald, LLC (``MIAX
Emerald'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission'') a proposed rule change as described in
Items I, II, and III below, which Items have been prepared by the
Exchange. The Commission is publishing this notice to solicit comments
on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange is filing a proposal to amend Exchange Rule 515A, MIAX
Emerald Price Improvement Mechanism (``PRIME'') and PRIME Solicitation
Mechanism; Rule 516, Order Types Defined; and Rule 517, Quote Types
Defined.
    The text of the proposed rule change is available on the Exchange's
website at http://www.miaxoptions.com/rule-filings/emerald at MIAX
Emerald's principal office, and at the Commission's Public Reference
Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend Exchange Rule 515A, MIAX Emerald
Price Improvement Mechanism (``PRIME'') and PRIME Solicitation
Mechanism. Specifically, the Exchange proposes to amend the rule to
adopt new rule text providing that Post-Only Orders \3\ and Post-Only
Quotes,\4\ collectively referred to as ``Post-Only OQs,'' may
participate in a PRIME Auction. Additionally, the Exchange proposes to
delete current Interpretation and Policy .07 and adopt new
Interpretations and Policies .07 and .08.
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    \3\ See Exchange Rule 516(m).
    \4\ See Exchange Rule 517(a)(1)(i).
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    PRIME is a process by which a Member \5\ may electronically submit
for execution (``Auction'') an order it represents as agent (``Agency
Order'') against principal interest, and/or an Agency Order against
solicited interest.\6\ Currently, Post-Only Orders may not participate
in a PRIME Auction and are rejected if received while a PRIME Auction
is in process.\7\ Similarly, the current rule provides that Post-Only
Quotes may not participate in a PRIME Auction and are rejected if
received during a PRIME Auction.\8\ Additionally, if trading interest
exists on the MIAX Emerald Book \9\ that is subject to the Managed
Interest Process pursuant to Exchange Rule 515(c) or there is a Post-
Only OQ subject to the POP Process on the MIAX Emerald Book for the
option on the same side of the market as the Agency Order, the Agency
Order will be rejected by the System \10\ prior to initiating an
Auction or Solicitation Auction.\11\
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    \5\ The term ``Member'' means an individual or organization
approved to exercise the trading rights associated with a Trading
Permit. Members are deemed ``members'' under the Exchange Act. See
Exchange Rule 100.
    \6\ See Exchange Rule 515A(a).
    \7\ See Exchange Rule 516(m).
    \8\ See Exchange Rule 517(a)(1)(i).
    \9\ The term ``Book'' means the electronic book of buy and sell
orders and quotes maintained by the System. See Exchange Rule 100.
    \10\ The term ``System'' means the automated trading system used
by the Exchange for the trading of securities. See Exchange Rule
100.
    \11\ See Exchange Rule 515A(a).07.
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    The Exchange now proposes to allow Post-Only OQs to participate in
a PRIME Auction and to be received during a PRIME Auction as described
in more detail below. The Exchange proposes to amend Exchange Rule
516(m), ``Post-Only Orders,'' to remove the sentence that provides that
Post-Only Orders may not participate in a PRIME Auction as set forth in
Rule 515A(a) and if received during a PRIME Auction will be rejected.
The Exchange also proposes to amend Exchange Rule 517(a)(1)(i), ``Post-
Only Quotes,'' to remove the sentence that provides that Post-Only
Quotes may not participate in a PRIME Auction as set forth in Rule
515A(a) and if received during a PRIME Auction will be rejected. In
addition to these proposed changes the Exchange also proposes to amend
Rule 515A(a)(1)(iv) which states, ``Post-Only OQs may not participate
in PRIME as an Agency Order,\12\ principal interest or solicited
interest. Post-Only OQs received during a PRIME Auction will be
rejected.'' The Exchange proposes to remove the second sentence which
states, ``Post-Only OQs received during a PRIME Auction will be
rejected.''
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    \12\ See Exchange Rule 515A(a).
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    The Exchange also proposes to amend subsection (a)(2)(i)(A) to
clarify that for both single price submissions and auto-match, if the
EBBO \13\ on the same side of the market as the Agency Order represents
a limit order on the Book or a Post-Only Quote subject to the POP
Process,\14\ the stop price must be at least $0.01 increment better
than the Book price. This proposed change supports the handling of
Post-Only OQs in PRIME and clarifies the stop price minimum
requirement.
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    \13\ The term ``EBBO'' means the best bid or offer on the
Exchange. See Exchange Rule 100.
    \14\ See Exchange Rule 515(i)(3).
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    The Exchange proposes to delete current Interpretation and Policy
.07 of Rule 515A in its entirety and to adopt new Interpretation and
Policy .07 in its stead. New Interpretation and Policy .07 will provide
that if trading interest exists on the MIAX Emerald Book that is
subject to the POP Process pursuant to Rule 515(i) for the option on
the opposite side of the market as the Agency Order, the Agency Order
will be automatically executed against the Post-Only interest if the
execution would be at a price $0.01 inside the EBBO. For an Agency
Order to buy, the price would be $0.01 higher than the EBB, and for an
Agency Order to sell the price would be $0.01 lower than the EBO. If
the Agency Order is not fully executed after the interest subject to
the POP Process is fully exhausted and is no longer at a price equal to
the initiating price of the Agency Order, the PRIME Auction will be
initiated for the balance of the Agency Order as provided in this Rule.
With respect to any portion of an Agency Order that is automatically
executed against managed interest pursuant to this paragraph .07, the

exposure requirements contained in Rule 520(b) and (c) will not be
satisfied just because the Member utilized the PRIME. The following two
examples demonstrate how Post-Only interest resting on the Book is
handled.
    Example 1. A resting Post-Only OQ subject to the POP Process \15\
on the opposite side from the Agency Order causes the Agency Order to
automatically execute against the Post-Only interest at a price $0.01
better than the EBBO.
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    \15\ The POP Process is engaged if the limit price of a Post-
Only OQ locks or crosses the current side EBBO where the EBBO is the
NBBO. See Exchange Rule 515(i)(3)(ii).

MPV: \16\ .05
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    \16\ The term ``MPV'' means minimum price variations. See
Exchange Rule 510.
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EBBO: 3.00-3.10 (10x10)
ABBO: \17\ 3.00-3.10 (10x10)
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    \17\ The term ``ABBO'' or ``Away Best Bid or Offer'' means the
best bid(s) or offer(s) disseminated by other Eligible Exchanges
(defined in Rule 1400(f)) and calculated by the Exchange based on
market information received by the Exchange from OPRA. See Exchange
Rule 100.
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Post-Only Order: Sell 1 @3.00

    The Exchange receives a Post-Only order to sell at 3.00. Since the
Post-Only order is priced equal to the opposite side EBBO it is subject
to the POP Process and is therefore booked at 3.05 with a display price
of 3.05.

EBBO: 3.00-3.05 (10x1)
PRIME Agency Order: Buy 10 @3.05 \18\
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    \18\ The Initiating Member must stop the entire Agency Order as
principal or with a solicited order at the better of the NBBO or the
Agency Order's limit price (if the order is a limit order). See
Exchange Rule 515A(a)(1)(ii).

    The Exchange then receives a PRIME Agency Order to buy at a price
equal to the opposite side EBBO, which includes a Post-Only order
subject to the POP Process (without a POP, this would not occur). Since
trading interest exists on the MIAX Emerald Book subject to the POP
Process on the opposite side of the market from the Agency Order, the
Agency Order is automatically executed against the Post-Only interest
$0.01 better than the same side EBB.
    The PRIME Agency Order to Buy, trades 1 @ 3.01 with the Sell Post-
Only order subject to the POP Process.
    Since the Agency Order is not fully executed after the Post-Only
interest is exhausted, an Auction is initiated for the balance of the
order. A Request for Responses (``RFR'') is broadcast to all
subscribers detailing the option, side, size and initiating price, and
the RFR period is started.\19\
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    \19\ See Exchange Rule 515A(a)(2)(i)(B).
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    No Responses are received.
    The PRIME Auction process will trade the Agency Order with the
Contra interest.
    The PRIME Agency Order buys 9 from the Contra interest @ 3.05.
    Example 2. A resting Post-Only OQ subject to the Managed Interest
Process on the opposite side from the Agency Order causes the Agency
Order to automatically execute against the Managed Interest at a price
equal to or better than the initiating price of the Agency Order.

MPV: .05
EBBO: 2.95-3.10 (10x10)
ABBO: 3.00-3.10 (10x10)

    The Exchange receives a Post-Only order to sell at 3.00. Since the
Post-Only order is priced equal to the opposite side ABBO, it is
subject to the Managed Interest Process and is therefore booked at 3.00
with a display price of 3.05.

EBBO: 2.95-3.05 (10x1)
PRIME Agency Order: Buy 10 @ 3.05

    The Exchange then receives a PRIME Agency Order to buy at a price
equal to opposite side Post-Only order. Since trading interest exists
on the MIAX Emerald Book subject to the Managed Interest Process on the
opposite side of the market from the Agency Order, the Agency Order is
automatically executed against the Post-Only interest at the resting
Managed Interest's Book Price.
    The PRIME Agency Order to Buy, trades 1 @ 3.00 with the Sell Post-
Only order subject to the Managed Interest Process.
    Since the Agency Order is not fully executed after the Post-Only
interest is exhausted, an Auction is initiated for the balance of the
order. A Request for Responses (``RFR'') is broadcast to all
subscribers and the RFR period is started.
    No Responses are received.
    The PRIME Auction process will trade the Agency Order with the
Contra interest.
    The PRIME Agency Order buys 9 from the Contra interest @ 3.05.
    The Exchange also proposes to adopt new Interpretation and Policy
.08 to Rule 515A, to state that if trading interest exists on the MIAX
Emerald Book that is subject to the Managed Interest Process pursuant
to Rule 515(c) or the POP Process pursuant to Rule 515(i) for the
option on the same side of the market as the Agency Order, the Agency
Order will be rejected by the System prior to initiating an Auction or
Solicitation Auction. The following examples demonstrate this behavior.
    Example 3. A resting Post-Only OQ subject to Managed Interest
Process on the same side as the Agency Order causes the Agency Order to
be rejected.

MPV: .01
EBBO: 1.00-1.06 (10x10)
ABBO: 1.00-1.05 (10x10)
Post-Only Order: Buy 1 @ 1.05

    The Exchange receives a Post-Only order to buy at 1.05. Since the
Post-Only order is priced equal to the opposite side ABBO, it is
subject to the Managed Interest Process and is therefore booked at 1.05
with a display price of 1.04.

EBBO: 1.04-1.06 (10x1)
PRIME Agency Order: Buy 10 @ 1.05

    The Exchange then receives a PRIME Agency Order to buy at 1.05 on
the same side as the Post-Only order subject to the Managed Interest
Process. Since trading interest exists on the MIAX Emerald Book subject
to the Managed Interest Process on the same side of the market as the
Agency Order, the Agency Order is rejected.
    Example 4. A resting Post-Only OQ subject to POP Process on the
same side as the Agency Order causes the Agency Order to be rejected.

MPV: .01
EBBO: 1.00-1.05 (10x10)
ABBO: 1.00-1.05 (10x10)
Post-Only Order: Buy 1 @ 1.05

    The Exchange receives a Post-Only order to buy at 1.05. Since the
Post-Only order is priced equal to the opposite side EBBO it is subject
to the POP Process and is therefore booked at 1.04 with a display price
of 1.04.

EBBO: 1.04-1.05 (1x10)
PRIME Agency Order: Buy 60 @ 1.05

    The Exchange then receives a PRIME Agency Order to buy at 1.05 on
the same side as the Post-Only order. Since trading interest exists on
the MIAX Emerald Book subject to the POP Process on the same side of
the market as the Agency Order, the Agency Order is rejected.
Auction Termination
    An Auction shall conclude upon receipt by the System of an
unrelated order, including a Post-Only Order, (in the same option as
the Agency Order); (i) on the opposite side of the market from the RFR
responses, that is marketable against either the NBBO, the initiating
price, or the RFR response; or (ii) on the same side of the market as
the RFR responses, that is marketable against the NBBO.\20\ An Auction
will also conclude if the System receives an unrelated limit order,
including a Post-Only Order, (in the same option as the Agency Order)
on the opposite side of the market from the Agency Order that improves
any RFR response.\21\ Additionally, an Auction may conclude for any of
the other reasons provided for in Rule 515A.\22\
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    \20\ See Exchange Rule 515A(a)(2)(ii)(B) and (C).
    \21\ See Exchange Rule 515A(a)(2)(ii)(D).
    \22\ See Exchange Rule 515A(a)(2)(ii).

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    Post-Only Orders and Post-Only Quotes received during a PRIME
Auction are treated in similar fashion to other unrelated interest
received during a PRIME Auction as described in Rule 515A, however
Post-Only Orders and Post-Only Quotes, by definition, will not remove
liquidity.\23\ If, at the conclusion of a PRIME Auction, same side
Post-Only interest remains, the Post-Only interest will be subject to
the POP Process as described in Exchange Rule 515(i).
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    \23\ See Exchange Rule 516(m) and 517(a)(1)(i) respectively.
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    Additionally, the Exchange proposes to amend Interpretation and
Policy .12(b) of Rule 515A, which currently describes three scenarios
where the System will reject a cPRIME Agency Order at the time of
receipt. The Exchange proposes to amend paragraph (b)(iii) which
currently provides that a cPRIME Agency Order will be rejected at the
time of receipt if any component of the strategy is subject to the
Managed Interest Process described in Rule 515(c)(1)(ii). The Exchange
proposes to include a reference to Market Maker orders and quotes which
may be managed, as described in Rule 515(d); and Post-Only interest
being managed under the Post-Only Price Process, as described in Rule
515(i). The Exchange has two separate order management processes for
orders; one for non-routable orders, and one specifically for Post-Only
Orders (the Post-Only Price Process). Additionally, the Exchange has a
management process for Market Maker orders and quotes which operates
similarly to the Managed Interest Process.\24\ The Exchange proposes to
specify that the System will reject a cPRIME Agency Order at the time
of receipt if any component of the strategy is subject to the Managed
Interest Process described in Rule 515(c)(1), Rule 515(d), or the Post-
Only Price Process described in Rule 515(i), to ensure that the
integrity of the simple market remains intact. Finally, the Exchange
proposes to make a minor non-substantive change to Interpretation and
Policy .06 of Rule 515A, to clarify the term ``order'' in the second
sentence of the paragraph refers to an Agency Order, and to capitalize
the word ``rule'' in the same sentence, to align the text of
Interpretation and Policy .06 to the proposed text of Interpretation
and Policy .07.
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    \24\ See Exchange Rule 515(d)(ii).
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    The Exchange also proposes to amend subsection (m) of Exchange Rule
516, Order Types Defined, to delete the statement from the rule text
that states, Post-Only Orders may not participate in a PRIME Auction as
set forth in Rule 515A(a) and if received during a PRIME Auction will
be rejected. Similarly, the Exchange proposes to amend subsection
(a)(1)(i) of Exchange Rule 517, Quote Types Defined, to delete the
statement from the rule text that states, Post-Only Quotes may not
participate in a PRIME Auction as set forth in Rule 515A(a) and if
received during a PRIME Auction will be rejected. It is necessary for
the Exchange to remove this rule text, as under this proposal Post-Only
Orders and Post-Only Quotes may be eligible to participate in a PRIME
Auction. Additionally, under this proposal, Post Only Orders and Post-
Only Quotes received by the System during a PRIME Auction will not be
rejected.
2. Statutory Basis
    The Exchange believes that its proposed rule changes are consistent
with Section 6(b) of the Act \25\ in general, and furthers the
objectives of Section 6(b)(5) of the Act \26\ in particular, in that it
is designed to prevent fraudulent and manipulative acts and practices,
to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in facilitating
transactions in securities, to remove impediments to and perfect the
mechanisms of a free and open market and a national market system and,
in general, to protect investors and the public interest.
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    \25\ 15 U.S.C. 78f(b).
    \26\ 15 U.S.C. 78f(b)(5).
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    The proposal to allow Post-Only OQs to participate in a PRIME
Auction and to be received during a PRIME Auction promotes just and
equitable principles of trade, removes impediments to and perfects the
mechanisms of a free and open market and a national market system and,
in general, protects investors and the public interest by increasing
the potential liquidity that may be available during a PRIME Auction
which may result in possible price improvement opportunities. It is in
the investor's best interest to receive the best order execution price.
    The proposal to amend Exchange Rule 516(m) and Exchange Rule
517(a)(1)(i) to remove a provision that Post-Only Orders and Post-Only
Quotes, respectively, received during a PRIME Auction are rejected,
promotes just and equitable principles of trade, removes impediments to
and perfects the mechanisms of a free and open market and a national
market system and, in general, protects investors and the public
interest by ensuring that the Exchange's rules are accurate and precise
concerning the handling of Post-Only Orders and Post-Only Quotes. It is
in investors and the public's interest for Exchange rules to be
accurate and concise so as to avoid the potential for confusion.
    The proposal to amend Rule 515A(a)(2)(ii) to add additional text
clarifying the inclusion of Post-Only Orders in certain scenarios that
will end a PRIME Auction adds clarity and precision to the Exchange's
rule text. It is in investors and the public's interest for Exchange
rules to be accurate and concise so as to avoid the potential for
confusion.
    The proposal to adopt new Interpretation and Policy .07 regarding
the System's behavior for trading interest on the Emerald Book subject
to the POP Process promotes just and equitable principles of trade,
removes impediments to and perfects the mechanisms of a free and open
market and a national market system and, in general, protects investors
and the public interest by including resting interest in the PRIME
Auction process. Under the Exchange's existing rule the System would
reject an Agency Order prior to initiating an Auction if there was
resting interest for the option on the same side of the market as the
Agency Order. This proposal provides that this interest will now be
included in the PRIME Auction which benefits investors and the public
interest by including more liquidity in the Auction process and
allowing the Auction to occur.
    The proposal to adopt new Interpretation and Policy .08 promotes
just and equitable principles of trade, removes impediments to and
perfects the mechanisms of a free and open market and a national market
system and, in general, protects investors and the public interest by
providing additional detail regarding trading interest on the MIAX
Emerald Book that is subject to the Managed Interest Process or the POP
Process. Under the Exchange's existing rule if trading interest existed
on the Book that was subject to the Managed Interest Process for the
option on the same side of the market as the Agency Order the System
would reject the Agency Order prior to initiating an Auction. This
behavior remains the same under the Exchange's proposal. Under the
Exchange's existing rule if there was a Post-Only OQ on the Book for
the option on the same side of the market as the Agency Order the
System would reject the Agency Order prior to initiating an Auction.
Under the Exchange's proposal, the Exchange has clarified that if there
is interest on the Book in the option on the same side of the market as
the Agency Order that is

subject to the POP Process pursuant to Rule 515(i) the System will
reject the Agency Order prior to initiating an Auction. The Exchange
believes this change more accurately describes the behavior of the
System in this circumstance and it is in investors and the public's
interest for Exchange rules to be accurate and concise so as to avoid
the potential for confusion.
    The proposal to amend Interpretation and Policy .12 of Exchange
Rule 515A, to add additional conditions which will prevent a cPRIME
Agency Order from being received promotes just and equitable principles
of trade and protects investors and the public interest by ensuring
that the integrity of the Simple Market remains intact by rejecting a
cPRIME Agency Order if any component of the strategy is subject to a
management process or the Post-Only Price Process. The Exchange
believes the proposed rule change removes impediments to and perfects
the mechanism of a free and open market and a national market system
and will result in more efficient trading by ensuring orderly markets
involving complex orders with common components. The proposed rule
change will protect investors and the public interest by ensuring that
executions occurring in a cPRIME auction are valid.
    Additionally, the Exchange believes that including additional
scenarios which will terminate a cPRIME Auction promotes just and
equitable principles of trade and removes impediments to a free and
open market by providing greater transparency concerning the operation
of Exchange functionality. This provision ensures that a cPRIME Agency
Order will always receive the best price on the Exchange while
simultaneously preserving the integrity of the simple market.
    The proposal to amend Exchange Rule 516 and Rule 517 to remove rule
text which states that Post-Only Orders and Post-Only eQuotes,
respectively, may not participate in PRIME Auctions and if received
during an Auction will be rejected, ensures that the rules of the
Exchange accurately describe the Exchange's functionality.
    The Exchange believes the proposed changes promote just and
equitable principles of trade and remove impediments to and perfect the
mechanism of a free and open market and a national market system
because they seek to add additional detail to, and improve the accuracy
of, the Exchange's rules. In particular, the Exchange believes that the
proposed rule changes will provide clarity and transparency of the
Exchange's rules to Members and the public, and it is in the public
interest for rules to be accurate and concise so as to minimize the
potential for confusion.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed rule change is
intended to promote competition by expanding the type of interest that
may participate in a PRIME Auction.
    The Exchange believes that this enhances intermarket competition by
enabling the Exchange to compete for this type of order flow with other
exchanges that have similar rules and functionality in place.
    The Exchange does not believe the proposal will impose any burden
on intra-market competition as the Exchange's rules apply equally to
all Members of the Exchange.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the Exchange consents, the Commission shall: (a) By order approve
or disapprove such proposed rule change, or (b) institute proceedings
to determine whether the proposed rule change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-EMERALD-2019-19 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to File Number SR-EMERALD-2019-19. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-EMERALD-2019-19 and should be submitted
on or before May 31, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\27\
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    \27\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-09629 Filed 5-9-19; 8:45 am]
 BILLING CODE 8011-01-P