[Federal Register Volume 81, Number 85 (Tuesday, May 3, 2016)]
[Proposed Rules]
[Pages 26487-26490]
[FR Doc No: 2016-09789]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-6144; Directorate Identifier 2015-NM-088-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Airbus Model A318, A319, and A320 series airplanes; Model A330-
200, -200 Freighter, and -300 series airplanes; and Model A340-200, -
300, -500, and -600 series airplanes. This proposed AD was prompted by
fuel system reviews conducted by the manufacturer. This proposed AD
would require modifying the fuel quantity indicating system (FQIS) to
prevent development of an ignition source inside the center fuel tank
due to electrical fault conditions. This proposed AD would also provide
alternative actions for cargo airplanes. We are proposing this AD to
prevent ignition sources inside the center fuel tank, which, in
combination with flammable fuel vapors, could result in a fuel tank
explosion and consequent loss of the airplane.

DATES: We must receive comments on this proposed AD by June 17, 2016.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-

30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue
SE., Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
6144; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Office (phone:<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2016-6144;
Directorate Identifier 2015-NM-088-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The FAA has examined the underlying safety issues involved in fuel
tank explosions on several large transport airplanes, including the
adequacy of existing regulations, the service history of airplanes
subject to those regulations, and existing maintenance practices for
fuel tank systems. As a result of those findings, we issued a
regulation titled ``Transport Airplane Fuel Tank System Design Review,
Flammability Reduction and Maintenance and Inspection Requirements''
(66 FR 23086, May 7, 2001). In addition to new airworthiness standards
for transport airplanes and new maintenance requirements, this rule
included Special Federal Aviation Regulation No. 88 (``SFAR 88''),
Amendment 21-78. Subsequently, SFAR 88 was amended by: Amendment 21-82
(67 FR 57490, September 10, 2002; corrected at 67 FR 70809, November
26, 2002) and Amendment 21-83 (67 FR 72830, December 9, 2002; corrected
at 68 FR 37735, June 25, 2003, to change ``21-82'' to ``21-83'').
    Among other actions, SFAR 88 requires certain type design (i.e.,
type certificate (TC) and supplemental type certificate (STC)) holders
to substantiate that their fuel tank systems can prevent ignition
sources in the fuel tanks. This requirement applies to type design
holders for large turbine-powered transport airplanes and for
subsequent modifications to those airplanes. It requires them to
perform design reviews and to develop design changes and maintenance
procedures if their designs do not meet the new fuel tank safety
standards. As explained in the preamble to the rule, we intended to
adopt airworthiness directives to mandate any changes found necessary
to address unsafe conditions identified as a result of these reviews.
    In evaluating these design reviews, we have established four
criteria intended to define the unsafe conditions associated with fuel
tank systems that require corrective actions. The percentage of
operating time during which fuel tanks are exposed to flammable
conditions is one of these criteria. The other three criteria address
the failure types under evaluation: Single failures, combination of
failures, and unacceptable (failure) experience. For all three failure
criteria, the evaluations included consideration of previous actions
taken that may mitigate the need for further action.
    We have determined that the actions identified in this proposed AD
are necessary to reduce the potential of ignition sources inside fuel
tanks, which, in combination with flammable fuel vapors, could result
in fuel tank explosions and consequent loss of the airplane.

Model A320/330/340 FQIS Design

    The design of the in-tank FQIS components and wiring has the
potential for a latent FQIS electrical fault condition inside the fuel
tank combined with an electrical hot short condition connecting a high
power source to the FQIS wiring to cause an ignition source in a fuel
tank.
    Under the policy contained in FAA Policy Memo PS-ANM100-2003-112-
15, SFAR 88--Mandatory Action Decision Criteria, dated February 25,
2003 (http://rgl.faa.gov/Regulatory_and_Guidance_Library/rgPolicy.nsf/
0/dc94c3a46396950386256d5e006aed11/$FILE/Feb2503.pdf), the FAA
determined that this ignition source risk combined with the fleet
average flammability for the center wing tank on airplanes affected by
this NPRM created an unsafe condition for the center fuel tank.
Applying that same policy, the FAA determined that due to a lower fleet
average flammability, that same unsafe condition does not exist in the
main wing tanks (inner and outer) and tail trim tank of these
airplanes.

Related Rulemaking

    On March 21, 2016, we issued AD 2016-07-07, Amendment 39-18452 (81
FR 19472, April 5, 2016), for certain Boeing Model 757-200, -200PF, -
200CB, and -300 series airplanes. AD 2016-07-07 requires similar
actions to those proposed in this NPRM. AD 2016-07-07 addressed the
numerous public comments that were submitted on the proposal.

FAA's Determination

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. We are
proposing this AD because we evaluated all the relevant information and
determined the unsafe condition described previously is likely to exist
or develop in other products of the same type design.
    In accordance with FAA policy memo SFAR 88--Mandatory Action
Decision Criteria, dated February 25, 2003, we have determined that the
unsafe condition warrants issuance of an AD to mandate the actions
proposed in this NPRM.

Proposed AD Requirements

    This proposed AD would require modifying the FQIS to prevent
development of an ignition source inside the center fuel tank due to
electrical fault conditions. As an alternative for cargo airplanes,
this proposed AD would provide the alternative to modify the airplane
by separating FQIS wiring routed between the fuel quantity indicating
(FQI) computer and the center fuel tank, provided repetitive BITE
(built-in test equipment) checks of the FQI computer are also
performed.

Costs of Compliance

    We estimate that this proposed AD affects 1 airplane of U.S.
registry.
    We also estimate that it would take about 1,200 work-hours per
product to comply with the basic requirements of this proposed AD. The
average labor rate is $85 per work-hour. We have received no definitive
data that would enable us to provide cost estimates for the parts
needed to do the actions specified in this proposed AD. Based on these
figures, we estimate the labor cost of this proposed AD on U.S.
operators to be $102,000.
    We have not received definitive information on the costs for the
alternative wire separation modification specified in this NPRM. The
cost for this action in similar rulemaking on other airplanes, however,
suggests that this modification could take about 74 work-hours with
parts costing about $10,000, for a total estimated cost to U.S.
operators of $16,290 per product.
    We estimate that the repetitive FQIS tank circuit checks associated
with the alternative wire separation modification would take about 1
work-hour per check. We estimate the cost of this check on U.S.
operators to be $85 per product, per check.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

Airbus: Docket No. FAA-2016-6144; Directorate Identifier 2015-NM-
088-AD.

(a) Comments Due Date

    We must receive comments by June 17, 2016.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to the Airbus airplanes, certificated in any
category, identified in paragraphs (c)(1) through (c)(6) of this AD,
except airplanes equipped with a flammability reduction means (FRM)
approved by the FAA as compliant with the Fuel Tank Flammability
Reduction (FTFR) rule (73 FR 42444, July 21, 2008) requirements of
14 CFR 25.981(b) or 14 CFR 26.33(c)(1).
    (1) Airbus Model A318-111, -112, -121, and -122 airplanes.
    (2) Airbus Model A319-111, -112, -113, -114, -115, -131, -132,
and -133 airplanes.
    (3) Airbus Model A320-211, -212, -214, -231, -232, and -233
airplanes.
    (4) Model A330-201, -202, -203, -223, -223F, -243, and -243F
airplanes.
    (5) Model A330-301, -302, -303, -321, -322, -323, -341, -342,
and -343 airplanes fitted with a center fuel tank.
    (6) Model A340-211, -212, -213, -311, -312, -313, -541, and -642
airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 28, Fuel.

(e) Unsafe Condition

    This AD was prompted by fuel system reviews conducted by the
manufacturer. We are issuing this AD to prevent ignition sources
inside the center fuel tank, which, in combination with flammable
fuel vapors, could result in a fuel tank explosion and consequent
loss of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Modification

    Within 60 months after the effective date of this AD, modify the
fuel quantity indicating system (FQIS) to prevent development of an
ignition source inside the center fuel tank due to electrical fault
conditions, using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA.

(h) Alternative Actions for Cargo Airplanes

    For airplanes used exclusively for cargo operations: As an
alternative to the requirements of paragraph (g) of this AD, do the
actions specified in paragraphs (h)(1) and (h)(2) of this AD. To
exercise this alternative, operators must perform the first
inspection required under paragraph (h)(1) of this AD within 6
months after the effective date of this AD. To exercise this
alternative for airplanes returned to service after conversion of
the airplane from a passenger configuration to an all-cargo
configuration more than 6 months after the effective date of this
AD, operators must perform the first inspection required under
paragraph (h)(1) of this AD prior to further flight after the
conversion.
    (1) Within 6 months after the effective date of this AD, record
the existing fault codes stored in the fuel quantity indicating
(FQI) computer, and then do a BITE check (check of built-in test
equipment) of the FQI computer, using a method approved by the
Manager, International Branch, ANM-116, Transport Airplane
Directorate, FAA. If any fault code is recorded prior to the BITE
check or as a result of the BITE check, before further flight, do
all applicable repairs and repeat the BITE check until a successful
test is performed with no fault found, using a method approved by
the Manager, International Branch, ANM-116, Transport Airplane
Directorate, FAA. Repeat these actions thereafter at intervals not
to exceed 650 flight hours. Modification as specified in paragraph
(h)(2) of this AD does not terminate the repetitive BITE check
requirement of this paragraph.
    (2) Within 60 months after the effective date of this AD, modify
the airplane by separating FQIS wiring that runs between the FQI
computer and the center fuel tank wall penetrations, including any
circuits that might pass through a main fuel tank, from other
airplane wiring that is not intrinsically safe, using methods
approved by the Manager, International Branch, ANM-116, Transport
Airplane Directorate, FAA.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, International Branch, ANM-116, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the ACO, send it to the attention of the
person identified in paragraph (j) of this AD.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(j) Related Information

    For more information about this AD, contact Dan Rodina,
Aerospace Engineer, International Branch, ANM-116, Transport
Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-
3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

    Issued in Renton, Washington, on April 15, 2016.
Victor Wicklund,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-09789 Filed 5-2-16; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 222 (Monday, November 22, 2021)]
[Rules and Regulations]
[Pages 66180-66189]
[FR Doc No: 2021-25376]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2016-N-0400]

Medical Devices; General and Plastic Surgery Devices;
Reclassification of Blood Lancets

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
issuing a final order to reclassify three types of blood lancets used
to puncture skin to obtain a drop of blood for diagnostic purposes from
class I (general controls) exempt from premarket notification into
class II (special controls) and subject to premarket notification,
specifically, single use only blood lancets with an integral sharps
injury prevention feature, single use only blood lancets without an
integral sharps injury prevention feature, and multiple use blood
lancets for single patient use only. FDA is designating special
controls for these three types of blood lancets based on the
determination that general controls only are not sufficient and there
is sufficient information to establish special controls to provide a
reasonable assurance of their safety and effectiveness. FDA is also
reclassifying a fourth type of blood lancet, multiple use blood lancets
for multiple patient use, from class I (general controls) exempt from
premarket notification into class III (premarket approval). FDA is
reclassifying these four types of blood lancets on its own initiative
based on new information.

DATES: This order is effective November 22, 2021. See further
discussion in section VI, Implementation Strategy.

FOR FURTHER INFORMATION CONTACT: Rebecca Nipper, Center for Devices and
Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 1540,
Silver Spring, MD 20993,<PHONE_NUMBER>, [email protected]; or
Stephen Ripley, Center for Biologics Evaluation and Research, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-
7911, [email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Table of Abbreviations/Commonly Used Acronyms in This Document
II. Background
    A. Classification
    B. Reclassification
    C. Requirement for Premarket Approval
III. Public Comments in Response to the Proposed Order
IV. The Final Order
V. Premarket Notification Requirement for Single Patient Use Only
Blood Lancets
VI. Implementation Strategy
VII. Codification of Orders
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. References

I. Table of Abbreviations/Commonly Used Acronyms in This Document

------------------------------------------------------------------------
       Abbreviation or acronym                   What it means
------------------------------------------------------------------------
510(k)...............................  Premarket Notification.
515(b) Proposed Order................  Proposed Order calling for
                                        premarket approval applications
                                        for class III blood lancets
                                        published on March 3, 2016 (81
                                        FR 11151).
513(e) Proposed Order................  Proposed Order to reclassify
                                        blood lancets published on March
                                        3, 2016 (81 FR 11140).
Agency...............................  Food and Drug Administration.
CDC..................................  Centers for Disease Control and
                                        Prevention.
CFR..................................  Code of Federal Regulations.
EPA..................................  Environmental Protection Agency.
FDA..................................  Food and Drug Administration.
FDASIA...............................  Food and Drug Administration
                                        Safety and Innovation Act.
FD&C Act.............................  Federal Food, Drug, and Cosmetic
                                        Act.
FR...................................  Federal Register.
HIV..................................  Human Immunodeficiency Virus.
OMB..................................  Office of Management and Budget.
Panel................................  General & Plastic Surgery Devices
                                        Panel of the Medical Devices
                                        Advisory Committee, device
                                        classification panel on June 26,
                                        2013.
PDP..................................  Product Development Protocol.
PMA..................................  Premarket Approval Application.
PRA..................................  Paperwork Reduction Act of 1995.
PT/INR...............................  Prothrombin Time and
                                        International Normalized Ratio.
Ref..................................  Reference.
UDI..................................  Unique Device Identifier.
UPC..................................  Universal Product Code.
U.S.C................................  United States Code.
------------------------------------------------------------------------

II. Background

A. Classification

    The Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 301
et seq.), as amended, 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 on
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.

B. Reclassification

    Section 513(e)(1) of the FD&C Act sets forth the process for
issuing a final order for reclassifying a device. 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.
    FDA published a proposed order in the Federal Register of March 3,
2016 (81 FR 11140), held a device classification panel meeting of the
General & Plastic Surgery Devices Panel of the Medical Devices Advisory
Committee, on June 26, 2013 (the Panel), as described in section 513(b)
of the FD&C Act with respect to the four different types of blood
lancet devices, and considered comments from public dockets. Therefore,
FDA has met the requirements under section 513(e)(1) of the FD&C Act.

C. Requirement for Premarket Approval

    Elsewhere in this issue of the Federal Register, FDA has published
a final order requiring the filing of a premarket approval application
(PMA) or notice of completion of a product development protocol (PDP)
for multiple patient blood lancets (class III). In practice, the option
of filing a notice of completion of a PDP has rarely been used by
manufacturers. For simplicity, while corresponding requirements for
PDPs remain available to manufacturers in response to a final order
under section 515(b) of the FD&C Act (21 U.S.C. 360e(b)), this document
will refer only to the requirement for the filing and obtaining
approval of a PMA.

III. Public Comments in Response to the Proposed Order

    In the Federal Register of March 3, 2016, FDA published a proposed
order to reclassify single patient use blood lancets from class I
(general controls) exempt from premarket notification to class II
(special controls) and to reclassify multiple patient blood lancets
from class I (general controls) exempt from premarket notification to
class III (premarket approval) (513(e) Proposed Order, 81 FR 11140)).
On that same date, FDA also published a proposed order to require the
filing of a PMA for multiple patient blood lancets (515(b) Proposed
Order) (81 FR 11151). The proposed orders also stated that FDA proposed
to amend 21 CFR part 878 to create a separate regulation under Sec.
878.4850 (21 CFR 878.4850) for all blood lancet types (previously
identified with product codes FMK or JCA). The comment periods for both
proposed orders closed on June 1, 2016.
    The March 3, 2016, 513(e) Proposed Order received approximately 150
comments from industry, professional societies, trade organizations,
and individual consumers by the close of the comment period. Certain
comments have been grouped together under a single comment since the
theme of the comments are similar in nature. The grouped comments and
FDA's response to each grouping are summarized in this section. The
number assigned to each comment is purely for organizational purposes
and does not signify the comment's value, importance, or the order in
which it was received.
    As previously set forth in the 513(e) Proposed Order, FDA
identified the following four subsets of blood lancet devices:
    1. A single use only blood lancet with an integral sharps injury
prevention feature is a disposable blood lancet intended for a single
use that is comprised of a single use blade attached to a solid, non-
reusable base (including an integral sharps injury prevention feature)
that is used to puncture the skin to obtain a drop of blood for
diagnostic purposes. The integral sharps injury prevention feature
allows the device to be used once and then renders it inoperable and
incapable of further use (``subset 1'');
    2. A single use only blood lancet without an integral sharps injury
prevention feature is a disposable blood lancet intended for a single
use that is comprised of a single use blade attached to a solid, non-
reusable base that is used to puncture the skin to obtain a drop of
blood for diagnostic purposes (``subset 2'');
    3. A multiple use blood lancet for single patient use only is a
multiple use capable blood lancet intended for use on a single patient
that is comprised of a single use blade attached to a solid, reusable
base that is used to puncture the skin to obtain a drop of blood for
diagnostic purposes (``subset 3''); and
    4. A multiple use blood lancet for multiple patient use is a
multiple use capable blood lancet intended for use on multiple patients
that is comprised of a single use blade attached to a solid, reusable
base that is used to puncture the skin to obtain a drop of blood for
diagnostic purposes (``subset 4'').
    (Comment 1) Several comments generally agreed with the proposed
reclassification of all four types of blood lancet devices. Some
comments supported the proposed precautions and labeling special
controls as necessary for healthcare providers and users of single
patient use blood lancets. Other comments agreed that the risks to
public health associated with use of multiple use blood lancets for
multiple patients are sufficiently significant for FDA to reclassify
this device type into class III (premarket approval).
    (Response 1) After considering the Panel's recommendations and
examination of scientific information (Ref. 1, and previously described
in the 513(e) Proposed Order (81 FR 11140 at 11142), FDA continues to
believe that there is sufficient evidence to establish special controls
that, together with general controls, provide a reasonable assurance of
safety and effectiveness to reclassify single patient use only blood
lancets to class II, as initially specified in the 513(e) Proposed
Order. Further, FDA continues to believe that blood lancets for
multiple patient use present a potential for unreasonable risk of
illness or injury, that insufficient information exists for FDA to
determine that special controls would provide a reasonable assurance of
safety and effectiveness of the device, and that blood lancets for
multiple patient use should be reclassified into class III.
    (Comment 2) Several comments stated that the evidence for a risk of
infection was associated with the use of blood lancets in a
professional care setting and therefore there was no evidence to

support reclassification of personal blood lancet devices in home use
environments.
    (Response 2) FDA disagrees with the comments that there is no
evidence to support the reclassification of single patient use blood
lancets for home use from class I (general controls) to class II
(special controls). At the Panel meeting on June 26, 2013, FDA
presented an analysis of the risks to health associated with the use of
blood lancets and new scientific data supporting these risks (Ref. 2).
Although the information on infection transmission was generated in
healthcare settings, FDA believes the risks to health are general risks
that apply to all single use patient blood lancets, regardless of the
environment in which they are used. Based on the scientific evidence
available to the Agency at that time, blood may be transmitted between
patient and care givers by the misuse of ``single use only'' medical
devices that are not intended for or labeled for reuse, because they
are not designed to be cleaned or sterilized to become safe for reuse,
such as needles or syringes (Ref. 2). Similarly, transmission may also
occur if validated cleaning and disinfection instructions are not
identified and followed for multiple use blood lancets for single
patient use only (subset 3). After reviewing the new scientific data
supporting the identified risks to health, the Panel recommended that
reclassifying single patient use blood lancets from class I (general
controls) to class II (special controls) will provide a reasonable
assurance of the safety and effectiveness of blood lancets for single
patient use.
    The Panel also acknowledged that many of the adverse event reports
of device problems indicate that accidental sticks are most likely when
safety features malfunction, the lancet is difficult to remove, or when
lancets are too dull to pierce the skin or too long to fit within the
safety caps (Ref. 2). From January 1, 2015, to May 31, 2021, FDA
received over 3,100 reports for blood lancets, most of which are device
malfunctions. The most commonly reported problems include accidental
blade sticks, the blade breaking off or remaining in a patient's
finger, and the blade protruding from the device cap or not retracting.
In addition, FDA received numerous reports of device malfunctioning and
retraction problems with the blood lancets.
    FDA agrees with the Panel that reclassification from class I to
class II is appropriate for single patient use blood lancets and is
supported by FDA's findings reported in the 513(e) Proposed Order,
adverse event reporting, and the panel executive summary (Ref. 2). FDA
also agrees with the Panel that premarket notification (510(k))
submissions are necessary for single patient use blood lancets to
ensure adequacy of the labeling concerning the limitation to single
patient use only, effective sharps injury prevention features that
disable the lancet from further use (when applicable), and blade
dispense release mechanisms on multiple use blood lancets for single
patient use only, as well as instructions for a safe blade disposal and
cleaning and disinfection for the multiple use blood lancets for single
patient use only. These special controls are consistent with the
special controls applicable to other similar device technology such as
injection needles (Ref. 2). As a result, FDA believes the premarket
notification requirement and the established special controls are
necessary to provide a reasonable assurance of safety and effectiveness
for all for single patient use blood lancets, whether they are used in
a home environment or a healthcare setting.
    (Comment 3) Several comments stated that the 513(e) Proposed Order,
if finalized, would increase the cost of blood lancets for single
patient use, putting an undue burden on patients, and would cause what
one comment referred to as ``economic driven disruption . . . with
lancet access driving use of less expensive devices'' in the wrong
setting.
    (Response 3) FDA appreciates the economic concerns raised by users
of blood lancets regarding the cost of this device; however,
reclassification decisions are based on the level of controls necessary
to ensure that reasonable assurance of safety and effectiveness
requirements under 21 CFR 860.7(d) and (e) as well as section 513(e) of
the FD&C Act are met. The regulatory requirements for blood lancets
established by FDA are based on the probable benefits to health for the
indications for use of blood lancet devices and the risk of the devices
when used as intended, and not the costs of the device. FDA also agrees
with the findings of the Panel and believes that to mitigate the known
risks to health posed by these devices, the proposed special controls
are necessary for single patient use only blood lancets, regardless of
their environment of use. In addition, FDA believes that manufacturers
of single patient use only blood lancets may already be complying with
some of the proposed special controls (e.g., biocompatibility testing
and package integrity testing) because they are industry standard type
tests (Ref. 2). Therefore, FDA does not believe the reclassification of
single patient use only blood lancets (subsets 1, 2, or 3) will result
in an economic disruption that will affect the availability of or
patient access to these devices for these intended purposes.
    (Comment 4) Several comments stated that the proposed special
controls related to the disinfection of skin and/or reusable device
components for single patient use blood lancets (subsets 1, 2, or 3),
along with the associated special controls concerning labeling and
validation, were either too burdensome or not appropriate. For example,
one comment did not understand why disinfection was needed for a single
patient home use device; a similar comment felt that cleaning and
disinfection validation was overly burdensome for single patient home
use devices. A few comments stated that disinfection of the skin would
adversely affect blood glucose monitoring by resulting in
vasoconstriction. Also, one comment suggested that FDA should not
mandate usage of Environmental Protection Agency (EPA) commercially
registered disinfectant if a commonly available generic disinfectant
agent is equally effective for home use.
    (Response 4) FDA believes that the special controls related to the
disinfection of reusable device components, along with the associated
special controls pertaining to labeling and validation, are appropriate
to ensure a reasonable assurance of safety and effectiveness for
multiple use blood lancets for single patient use (i.e., subset 3). To
reduce the risk of infection, FDA believes that reusable components of
single patient use lancets, such as reusable bases, should be
adequately cleaned and disinfected (i.e., reprocessed) between uses.
Without adequate reprocessing validation conducted initially by the
manufacturer for multiple use blood lancets for single patient use
under simulated use conditions, it is unclear whether adequate labeling
for cleaning and disinfection between uses by the end user can be
developed. Further, patient soil (e.g., skin cells, oil, dirt, skin
flora, and body fluids such as blood and sweat) can accumulate on the
reusable component over time, creating an ideal environment for
microbial growth. Although the lancet may be for single patient use,
soil can become transferred from the reusable base component to the
single-use lancet, thereby posing a risk of infection upon reuse of the
device in the same patient.
    At the Panel meeting, FDA presented an analysis of the risks to
health associated with the use of blood lancets and new scientific data
supporting these

risks. Beyond mitigating the risk of infection, the Panel felt that
reprocessing validation was necessary to demonstrate the functionality
of the device over its lifetime, since the device could degrade when
subjected to multiple cleaning and disinfection cycles (Ref. 2). FDA's
guidance entitled ``Reprocessing Medical Devices in Health Care
Settings: Validation Methods and Labeling'' provides recommendations
for validation methods and labeling for proper cleaning of reusable
medical devices that are consistent with the special controls in this
final order (Ref. 3). Furthermore, the special controls for proper
cleaning and disinfection of reusable components in this final order
are also consistent with the recommendations in FDA's guidances ``Self-
Monitoring Blood Glucose Test Systems for Over-the-Counter Use'' and
``Blood Glucose Monitoring Test Systems for Prescription Point-of-Care
Use,'' which concern devices that are used by some of the same patient
populations as those using blood lancets, both in a home use and
clinical environment (Refs. 1 and 4).
    FDA continues to believe that use of EPA-registered disinfectants
is necessary for cleaning and disinfection of the multiple use blood
lancets for single patient use even for home use settings. FDA
recommends utilizing disinfectants that are effective against
bloodborne pathogens, such as Human Immunodeficiency Virus (HIV),
Hepatitis B, and Hepatitis C viruses. FDA also recommends the use of
EPA-registered disinfectants because they have been demonstrated to be
effective against specific bloodborne pathogens when used for specified
contact times. EPA-registered disinfectants, which include both
commercially registered disinfectants and commonly available generic
disinfectant agents, are not allowed to make efficacy claims against
specific pathogens unless the EPA has reviewed data to support those
claims.
    FDA notes that preparation of skin is part of standard patient care
prior to drawing blood from patients, and that current guidelines and
standards (Refs. 5 and 6) generally include cleaning and disinfection
of skin prior to capillary blood sampling. The purpose of this skin
preparation step is to prevent infections caused by entry of microbial
flora on the patient's skin into the puncture wound created by the
blood lancet. Nonetheless, FDA recognizes that the skin preparation
procedure may differ depending on the particular application and/or
clinical use, and that specific guidelines may exist for skin
preparation for certain clinical applications. As such, FDA has revised
the special control regarding ``instructions on cleaning and
disinfection of the skin to be pierced'' to instead state
``instructions on preparation (e.g., cleaning, disinfection) of the
skin to be pierced.''
    As a result of the available scientific information, FDA has
determined that labeling special controls are necessary to address
safety risks associated with use as labeled, and possible misuse, of
blood lancets. In particular, it is critical to have specific required
labeling special controls related to the preparation of skin and
reprocessing of blood lancets for single patient use devices to provide
a reasonable assurance of safety and effectiveness.
    (Comment 5) Several comments stated that the proposed labeling for
single patient use only blood lancet devices is inadequate, overly
prescriptive, and/or unnecessary for blood lancets used in home use
environments.
    (Response 5) FDA continues to believe that the labeling proposed as
special controls for single patient use only blood lancets (subsets 1,
2, and 3) are necessary to provide a reasonable assurance of safety and
effectiveness for these devices and believes the current labeling for
blood lancets is inadequate. At the Panel meeting, FDA presented an
analysis of the risks to health associated with the use of blood
lancets and new scientific data supporting these risks. In the data
that was presented, it was shown that the risk of bloodborne pathogen
transmission was related to the improper use of blood lancets. FDA
believes that additional labeling is needed to address this safety risk
associated with misuse of blood lancets, including detailed
descriptions of the proper use of the device and any sharps injury
prevention feature, hand washing instructions for the user before and
after use of the device, instructions on cleaning and disinfection of
the device and to the skin to be pierced, and instructions for the safe
disposal of the device (Ref. 2). For each environment of use for blood
lancets, adequate labeling must be included to address either use of
these devices in healthcare settings or labeling for home use that is
written for the end users to be able to understand and follow the
instructions.
    FDA has determined that general controls alone are not sufficient
to provide a reasonable assurance of safety and effective for these
devices (subsets 1, 2, and 3), and there is sufficient information to
establish special controls to provide such an assurance; therefore, FDA
is reclassifying these devices into class II (81 FR 11140 at 11142).
The Panel consensus was that single patient use only blood lancets meet
the statutory definition of a class II device and require labeling
special controls related to the cleaning and disinfection of skin and
blood lancets for single patient use devices to reasonably assure
safety and effectiveness.
    (Comment 6) Some comments stated that the proposed 180-day
timeframe is too short for manufacturers of single patient use blood
lancets (subsets 1 to 3) to demonstrate conformance with the required
special controls and submit a premarket notification (510(k)). The
comments recommended timeframes ranging from 1 to 2 years for the
submission of new 510(k)s for these types of blood lancets.
    (Response 6) FDA agrees with the commenters' concern that its
proposal to not enforce compliance with the 510(k) requirement or
special controls for single patient use only blood lancets until 180
days after the effective date of the final order may not be enough time
for all manufacturers of single patient use blood lancets to implement
the required special controls and receive 510(k) clearance for those
devices without prior 510(k) clearance. The typical review time for a
510(k) is 90 days. However, if a 510(k) submission lacks the
information necessary for the Agency to continue or complete review,
FDA may issue a request for additional information to the submitter and
place the 510(k) on hold pending receipt of a complete response to the
identified deficiencies. FDA's current policy is to allow a sponsor 180
days to respond to a request for additional information,\1\ resulting
in a maximum review time of 270 days. Therefore, even if a submission
were made on the effective date, there could be instances where a
510(k) submission would remain pending beyond 180 days after the
effective date of the final order. FDA, therefore, does not intend to
enforce compliance with the 510(k) requirement or special controls
until 1 year after the effective date of this final order for blood
lancets for single patient use only that have been offered for sale
prior to the publication of this final order but do not already have a
510(k) clearance.
---------------------------------------------------------------------------

    \1\ See page 6 of Guidance for Industry and Food and Drug
Administration Staff entitled ``FDA and Industry Actions on
Premarket Notification (510(k)) Submissions: Effect on FDA Review
Clock and Goals'', available at https://www.fda.gov/media/73507/download.
---------------------------------------------------------------------------

    (Comment 7) There were several comments relating to the Unique
Device Identification labeling and data submission requirements. These
requirements apply to all devices in commercial distribution as of
their established Unique Device

Identification compliance date unless an exception or alternative
applies. For those blood lancets that have been offered for sale prior
to November 22, 2021, the comments: (1) Expressed concerns that the
Unique Device Identification compliance date for class II and class III
devices will have already passed when this order is published, and
insufficient time will be provided to allow for compliance; (2)
requested that a period of 2 or 3 years be provided for compliance with
Unique Device Identification requirements; and (3) pointed out that
industry anticipated that their class I devices would use the product's
Universal Product Code (UPC) for purposes of unique device identifier
(UDI) implementation as permitted under Sec.  801.40(d) (21 CFR
801.40(d)), and that FDA has not provided a reasonable basis to remove
these devices from this provision. These comments further requested
that FDA grant a general exception or alternative to allow the devices
subject to this order, regardless of their classification, to utilize
their UPCs as their UDIs.
    (Response 7) There are three principal elements to Unique Device
Identification requirements: Labeling with a UDI, direct marking of
devices that are intended to be used more than once and intended to be
reprocessed between uses, and data submission to the Global Unique
Device Identification Database (GUDID) (see Sec.  801.20, 801.45, and
830.300 (21 CFR 801.20, 801.45, and 830.300)). In addition, the Unique
Device Identification final rule (78 FR 58786, September 24, 2013) (UDI
Rule) added Sec.  801.18 (21 CFR 801.18), which requires certain dates
on device labels to be in a standard format. As explained in the
preamble to the UDI Rule, FDA aligned the compliance date for standard
date format requirements under Sec.  801.18 with the compliance date by
which a device must bear a UDI on its label and packages under Sec.
801.20 to avoid the need to make changes to a device label more than
once to implement the requirements in the final rule.\2\ FDA disagrees
2 or 3 years is necessary for compliance with Unique Device
Identification labeling and data submission requirements. Rather, FDA
considered the commenters' request for additional time for compliance
with UDI requirements and believes that the compliance timeframes set
forth in section VI of this order provide sufficient time for
manufacturers to perform all the functions required to comply with UDI
labeling and data submission requirements, including converting
manufacturing processes and associated inventory management, and
submitting required information to GUDID. In addition, manufacturers
should consult existing UDI compliance policies, which may be
applicable to their reclassified devices. FDA's publicly available UDI
web page \3\ contains a comprehensive listing of UDI guidance documents
and compliance policies.
---------------------------------------------------------------------------

    \2\ See 78 FR 58786 at 58795, September 24, 2013.
    \3\ Available at: https://www.fda.gov/udi.
---------------------------------------------------------------------------

    FDA also disagrees that manufacturers of blood lancets should be
permitted to utilize their UPCs as their UDIs. As indicated in the
preamble to the UDI Rule (78 FR 58786 at 58798) the exception in Sec.
801.40(d) was purposely limited to class I devices due to their
relative low risk. For the reasons stated in the preamble to this
order, FDA no longer considers the blood lancet devices to be low risk
and is reclassifying them into class II and class III. Therefore, the
exception in Sec.  801.40(d) will no longer apply to these devices, and
FDA does not believe that a general exception or alternative to the UDI
labeling requirements would not be appropriate. An individual labeler
that believes a UPC rather than a UDI on its device label would provide
for more accurate, precise, or rapid device identification or would
better ensure the safety or effectiveness of the device, may submit a
request for an alternative under 21 CFR 801.55.
    (Comment 8) Several comments stated that the proposed special
controls are unclear and unnecessary for blood lancets for single
patient use blood lancets. Other comments specifically requested
clarification of the following special controls: (1) Design
characteristics related to single use only blood lancets without an
integral sharp injury prevention, (2) possible recognized consensus
standards for mechanical performance testing, (3) sterility testing for
the lancet only, and (4) FDA identification of recognized consensus
standards for biocompatibility testing and clarification on whether
testing should be completed for the finished product or only the
lancet.
    (Response 8) FDA continues to believe that special controls are
necessary for single patient use only blood lancets. At the Panel
meeting, FDA presented an analysis of the risks to health associated
with the use of blood lancets and new scientific data supporting these
risks. These risks to health are summarized in tables 1 to 3 of the
513(e) Proposed Order (81 FR 11140 at 11147). After deliberation, the
Panel concluded that the risks to health warranted reclassification of
blood lancets from class I devices, as general controls were deemed
insufficient to provide a reasonable assurance of safety and
effectiveness. The proposed special controls are intended to inform
manufacturers of the testing and information FDA believes to be
necessary to provide a reasonable assurance of safety and effectiveness
during the use of blood lancets, including single patient use only
blood lancets.
    FDA understands the confusion regarding the special control for
single use only blood lancets without an integral sharps injury
prevention feature regarding design to prevent sharp object injuries.
The special controls for single patient use only blood lancets
established by this final order are necessary to provide a reasonable
assurance of safety and effectiveness for those devices. Each subset of
blood lancets presents similar risks to health, but requires different
special controls due to their different design characteristics and risk
profiles. Design characteristics for blood lancets without an integral
sharp injury prevention feature must still address the risks of sharp
object injuries and bloodborne pathogen transmissions (see Sec.
878.4850(b)(2)(i)). Examples of how this could be achieved include, but
may not be limited to, the inclusion of a cap or blade cover. As
described in the 513(e) Proposed Order (81 FR 11140) and adopted in
this final order, these risks are also mitigated by mechanical
performance testing to prevent device breakage and labeling. FDA
believes that to satisfy the mechanical testing special control
manufacturers must demonstrate injury prevention features (as
applicable) and blade performance in single use single patient devices
(see Sec.  878.4850(a)(2)(ii) and (b)(2)(ii)); however, there is
currently no FDA-recognized consensus standard for mechanical tests,
methods, or acceptance criteria for this device type.
    At the Panel meeting, FDA presented an analysis of the risks to
health associated with the use of blood lancets and new scientific data
supporting these risks. FDA believes that reusable components of single
patient use devices, such as reusable bases, should be adequately
cleaned and disinfected (i.e., reprocessed) between uses in order to
prevent risk of infection. Sterility testing is applicable to any
device component that breaches the skin, thereby contacting the
underlying sterile tissue and/or blood in order to mitigate the risk of
infection. While this requirement commonly applies to the blade of the
blood lancet device, it may be possible for other components of a

blood lancet besides a ``blade'' to breach the skin. Therefore, FDA has
determined that the sterility special control should be revised to
clearly state that this special control applies to ``any device
component that breaches the skin (e.g., the blade)'' for the three
single patient use subtypes of blood lancets. The special control for
biocompatibility testing must be conducted on the final finished form
for the finished blood lancet device and is important to address the
risk of adverse tissue reaction (not infection).
    Manufacturers are encouraged to review the relevant FDA guidance
documents including, but not limited to the ``Submission and Review of
Sterility Information in Premarket Notification (510(k)) Submissions
for Devices Labeled as Sterile'' (Ref. 7) and ``Use of International
Standard ISO 10993-1, Biological Evaluation of Medical Devices-Part 1:
Evaluation and Testing Within a Risk Management Process'' (Ref. 8) for
recommendations on how to comply with the special control testing
requirements.
    Evidence of compliance with the special controls is required to
demonstrate reasonable assurance of safety and effectiveness and to
support 510(k) clearance. As stated above, FDA does not intend to
enforce compliance with the premarket notification (510(k)) requirement
and special controls for blood lancets for single patient use only that
have been offered for sale prior to the publication of this final order
but do not already have a 510(k) clearance. However, 1 year after the
effective date of this order, any: (1) Single use only blood lancet
with an integral sharps injury prevention feature that does not comply
with the special controls established in Sec.  878.4850(a)(2), (2)
single use only blood lancet without an integral sharps injury
prevention feature that does not comply with the special controls
established in Sec.  878.4850(b)(2), or (3) multiple use blood lancet
for single patient use only established in Sec.  878.4850(c)(2), will
be considered adulterated and misbranded (sections 501(f)(1)(B) and
502(o) of the FD&C Act (21 U.S.C. 351(f)(1)(B) and 352(o))) until such
time as the device complies with the special controls and any premarket
notification requirements.
    (Comment 9) A comment stated that currently marketed blood lancets
should be exempt from design controls because the safety concerns
raised by those single patient use devices are related to the labeling
and the use of blood lancets generally and not with the design of the
device. Instead the comment suggests a phased-in approach for design
control compliance for currently marketed devices, depending on whether
they meet the requirements pursuant to Sec.  807.81(a)(3) (21 CFR
807.81(a)(3)).
    (Response 9) FDA disagrees with this comment. The lancet blade is
designed to pierce the skin and draw blood and can present a puncture
hazard to anyone coming into contact with the device when the blade is
accessible. This hazard is associated with serious risks as described
in the 513(e) Proposed Order (81 FR 11140). Without the application of
design controls (21 CFR 820.30), FDA is unable to verify that
appropriate controls are in place to ensure that blood lancet devices
are designed and tested in such a way as to perform as intended under
the labeled conditions of use, and to provide a reasonable assurance of
safety and effectiveness. Therefore, FDA does not intend to allow a
phased-in approach for design control compliance of currently marketed
single patient use blood lancets.
    (Comment 10) A comment stated that the single patient use only
blood lancet devices should be exempt from premarket notification under
section 510(m) of the FD&C Act (21 U.S.C. 360(m)) and suggested that
special controls could be documented in the Design History File (DHF)
for FDA's review during routine audits/inspections.
    (Response 10) FDA does not agree that it is appropriate to exempt
single patient use only blood lancets from premarket notification at
this time. Section 510(m) of the FD&C Act provides that FDA may exempt
a class II device from the premarket notification requirements under
section 510(k) of the FD&C Act if FDA determines that premarket
notification is not necessary to provide reasonable assurance of the
safety and effectiveness of the device. There are a number of factors
FDA may consider to determine whether a 510(k) is necessary to provide
reasonable assurance of the safety and effectiveness of a class II
device. These factors are discussed in the guidance that the Agency
issued on February 19, 1998, entitled ``Procedures for Class II Device
Exemptions from Premarket Notification, Guidance for Industry and CDRH
Staff'' (Class II 510(k) Exemption Guidance) (Ref. 9). Based on the
scientific information available to the Agency at this time and
summarized in the 513(e) Proposed Order, FDA has determined these
factors currently are not met for single patient use only blood lancet
devices and that premarket notification is necessary to provide
reasonable assurance of safety and effectiveness for all three types of
single patient use blood lancets.
    FDA also does not agree with the comment that the Agency should
only review the DHF for a single patient use only blood lancet device
to determine whether there exists a reasonable assurance of safety and
effectiveness for the device. Under 21 CFR 820.3 a DHF is a compilation
of records that describes the design history of a finished device based
on the quality system regulations. Although a manufacturer of a legally
marketed device is required to keep a DHF for the device's design
control requirements, FDA usually does not review the DHF until
postmarket surveillance inspections of a class II device. For single
patient use only blood lancet devices, based on the scientific evidence
available to the Agency, FDA believes in order for the Agency to
determine whether there exists a reasonable assurance of safety and
effective for a device, it is necessary for compliance with the special
controls to be assessed prior to the device entering the market.
    (Comment 11) A comment recommended that FDA create a separate
regulatory classification category for ``flat, stainless steel'' blood
lancets in class I.
    (Response 11) FDA disagrees that a separate regulatory
classification is needed for flat, stainless steel blood lancets in
class I. FDA believes that the four subsets of lancets identified in
this final order encompass flat, stainless steel blood lancets; that
is, a flat, stainless steel blood lancet can be appropriately
categorized in any of these four subsets based on its intended use
(e.g., single vs. multiple use) and design characteristics (e.g.,
presence or lack of a sharps injury prevention feature). Furthermore,
at this time, FDA finds that the same risks to health (e.g., bloodborne
pathogen transmission, local tissue infections, adverse tissue
reactions) described herein for blood lancets apply to flat, stainless
steel blood lancets. Therefore, FDA finds that a separate
categorization for flat stainless steel blood lancets in class I is
neither necessary nor appropriate at this time.
    (Comment 12) One comment suggested FDA allow a bundling of several
devices with the same intended use for a 510(k) submission.
    (Response 12) Bundling refers to the inclusion of multiple devices
or multiple indications for use for a device in a single premarket
submission, including products subject to the device and biologics
license application (BLA) authorities, for purposes of review and user
fee payment. Multiple devices may include different models within a
generic type of device (21 CFR 860.3) or

devices that are of differing generic types. Under the current review
process for the Center for Devices and Radiological Health (CDRH),
bundling of multiple devices or indications for use are acceptable for
510(k) submission when the devices present scientific and regulatory
issues that can most efficiently be addressed during the course of one
premarket review (Ref. 10). CDRH will make a determination of
acceptable bundling of devices on a case-by-case basis.
    (Comment 13) Some comments stated that all multiple use lancets
should be class III.
    (Response 13) FDA disagrees with this comment. FDA believes the
regulatory requirements for blood lancets should be based upon the
indications for use of the device and the risk of the device when used
as intended. After reviewing the new scientific data supporting the
identified risks to health, the Panel recommended that reclassifying
subset 3, multiple use for single patient use blood lancets from class
I (general controls) to class II (special controls) because multiple
use blood lancet devices for single use patients do not present a
potential unreasonable risk of illness or injury due to the inherent
and significantly increased risk of bloodborne pathogen transmission as
compared to multiple patient blood lancets (Ref. 2). As stated above in
response to Comment 2 in this section and in the 513(e) Proposed Order
(81 FR 11140 at 11148), FDA believes sufficient information exists to
establish special controls for mitigating the risks to health for
subset 3 (multiple use for single patient use only blood lancets) to
provide a reasonable assurance of safety and effectiveness of the
device. Because multiple use blood lancets for multiple patient use
present a potential unreasonable risk of illness or injury and
insufficient information exists to establish special controls for
multiple use blood lancets for multiple patient use, FDA reclassified
the device into class III.
    (Comment 14) Some comments stated that the wording of the subtypes
in the 513(e) Proposed Order were unclear and should be revised to
distinguish between lancets and lancing medical devices.
    (Response 14) FDA understands the concerns of the commenter and is
providing in this final order language to explain whether blades are
attached to the base in each of the four subsets of blood lancets. The
base and blade combine to create the complete lancet. For subset 1 and
2 lancets, the blade is attached to the base with the entire unit being
single use. In subset 3 and 4 lancets, single use blades are attached
to a multiuse base where the blade is discarded after each use, but
each subset has a different labeling requirement. By definition,
subsets 1 and 2 blood lancets do not have a blade that can be used
independently of the base. Furthermore, FDA provides clear descriptions
of special controls that apply to each component for subsets 1, 2, and
3. As discussed at the Panel, multiple use lancets for multiple
patients present an unreasonable risk of illness or injury due to the
inherent and significantly increased risk of bloodborne pathogen
transmission and are therefore reclassified into class III. Therefore,
FDA believes that the blood lancet definitions presented during the
Panel meeting and provided in the 513(e) Proposed Order are complete
and adequate.
    (Comment 15) Comment stated that FDA's increase of postmarket
surveillance of blood glucose meter accuracy would provide greater
impact on mitigating cross-contamination opportunities than
reclassification of blood lancets.
    (Response 15) Postmarket surveillance of blood glucose meter
accuracy is outside the scope of this regulatory action.

IV. The Final Order

    Under section 513(e) of the FD&C Act, FDA is adopting its findings
as published in the preamble to the 513(e) Proposed Order for these
devices (81 FR 11140). FDA is issuing this final order to reclassify
single patient use only blood lancets devices from class I (general
controls) exempt from premarket notification into class II (special
controls) and subject to premarket review.\4\ FDA is reclassifying
these devices based on the determination that general controls are
insufficient to provide a reasonable assurance of safety and
effectiveness for blood lancets and there is sufficient information to
establish special controls to provide such assurance for single patient
use only blood lancets (subsets 1 to 3). FDA is also establishing
special controls for each type of single patient use only blood lancet,
which are set forth in Sec.  878.4850(a)(2)(i) through (vi) for single
use only blood lancet with an integral sharps injury prevention
feature, Sec.  878.4850(b)(2)(i) through (vi) for single use only blood
lancet without an integral sharps injury prevention feature, and Sec.
878.4850(c)(2)(i) through (vii) for multiple use blood lancet for
single patient use only. FDA also intends not to enforce compliance
with this final order until 1 year after its effective date for
manufacturers of blood lancets for single patient use only that are
currently marketed for sale prior to the publication of this final
order, but do not already have a 510(k) clearance.
---------------------------------------------------------------------------

    \4\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
---------------------------------------------------------------------------

    FDA is also issuing this final order to reclassify multiple use
blood lancets for multiple patient use from class I (general controls)
exempt from premarket notification into class III (premarket approval).
FDA is reclassifying these devices based on the determination that
general controls and special controls together are not sufficient to
provide reasonable assurance of safety and effectiveness for this
device. In addition, in the absence of an established positive benefit-
risk profile, FDA has determined that the risks to health associated
with the use of multiple patient use blood lancets identified
previously present a potential unreasonable risk of illness or injury.
Elsewhere in this issue of the Federal Register, FDA has published a
final order requiring the filing of a PMA or notice of completion of a
PDP for multiple patient use blood lancets.
    FDA has also modified the identification in Sec.  878.4800(a) for
manual surgical instruments for general use to remove the blood lancet
devices from this classification regulation and include them under a
separate classification regulation Sec.  878.4850.

V. Premarket Notification Requirement for Single Patient Use Only Blood
Lancets

    FDA is reclassifying single patient use only blood lancets from
class I (general controls) exempt from premarket notification into
class II (special controls) and subject to premarket review. Section
510(m) of the FD&C Act provides that FDA may exempt a class II device
from the premarket notification requirements under section 510(k) of
the FD&C Act if FDA determines that premarket notification is not
necessary to provide reasonable assurance of the safety and
effectiveness of the device. FDA has determined that premarket
notification is necessary to provide reasonable assurance of safety and
effectiveness for the intended uses of all three types of single
patient use only blood lancets. Therefore, these three device types are
not exempt from premarket notification requirements.

    FDA cleared several 510(k)s for blood lancets prior to exempting
the device types from submission of a premarket notification. These
cleared blood lancets, as well as any 510(k)-exempt blood lancets
legally offered for sale on or before November 22, 2021, can serve as
predicates for substantial equivalence purposes. In order for a single
patient use only blood lancet to fall within this classification, it
would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order.

VI. Implementation Strategy

    For the three types of blood lancets being reclassified from class
I (general controls) to class II (special controls), the special
controls identified in this order are effective November 22, 2021. For
the fourth type of blood lancet being reclassified from class I to
class III, FDA is publishing a final order to require the filing of a
PMA or notice of completion of a PDP elsewhere in this issue of the
Federal Register.
     Blood lancets for single patient use only that have not
been offered for sale prior to November 22, 2021, or have been offered
for sale but are required to submit a new 510(k) under Sec.
807.81(a)(3): Manufacturers are required to obtain 510(k) clearance
before marketing their devices after November 22, 2021. If a
manufacturer markets such a device without receiving 510(k) clearance,
then FDA would consider taking action against such a manufacturer,
under its usual enforcement policies.
     Blood lancets for single patient use only that have been
offered for sale prior to November 22, 2021, and do not already have
510(k) clearance: FDA does not intend to enforce compliance with the
510(k) requirement or special controls until November 22, 2022. After
that date, if a manufacturer continues to market such a device but does
not have a 510(k) clearance or FDA determines that the device is not
substantially equivalent or not compliant with the special controls,
then FDA would consider taking action against such manufacturer under
its usual enforcement policies.
    For blood lancets for single patient use that have prior 510(k)
clearance, FDA would accept a new 510(k) and would issue a new
clearance letter, as appropriate, indicating substantial equivalence
and compliance with the special controls. These devices could serve as
predicates for new devices. These clearance letters would be made
publicly available in FDA's 510(k) database, and compliance with
special controls at the time of clearance would be stated in the
publicly available 510(k) Summary posted in this database. Because many
blood lancets for single patient use are non-prescription (``over-the-
counter'') devices, FDA believes that our public database is a
transparent tool allowing consumers to confirm that their devices have
been submitted under a new 510(k) and demonstrated conformance to the
applicable special controls.
    The timeframes set forth in this section also apply to compliance
with requirements for device labeling (part 801 (21 CFR part 801)),
including the UDI labeling requirements (part 801, subpart B), as well
as device tracking requirements (21 CFR part 821), device reporting
requirements (21 CFR part 803), and GUDID data submission requirements
(21 CFR part 830).

VII. Codification of Orders

    Prior to the amendments by the Food and Drug Administration Safety
and Innovation Act (FDASIA), section 513(e) of the FD&C Act provided
for FDA to issue regulations to reclassify devices. Although section
513(e) as amended requires FDA to issue final orders rather than
regulations, FDASIA also provides for FDA to revoke previously issued
regulations by order. FDA will continue to codify classifications and
reclassifications in the Code of Federal Regulations (CFR). Changes
resulting from final orders will appear in the CFR as changes to
codified classification determinations or as newly codified orders.
Therefore, under section 513(e)(1)(A)(i) of the FD&C Act, as amended by
FDASIA, in this final order, we are revoking the requirements in 21 CFR
878.4800 related to the classification of blood lancets as class I
devices and codifying the reclassification of four types of blood
lancets in 21 CFR 878.4850: Single use only blood lancets with an
integral sharps injury prevention feature, single use only blood
lancets without an integral sharps injury prevention feature, and
multiple use blood lancets for single patient use only into class II,
and multiple use blood lancet for multiple patient use into class III.

VIII. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 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.

IX. Paperwork Reduction Act of 1995

    While this final order contains no collection of information, it
does refer to previously approved FDA collections of information.
Therefore, clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this final order. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 807, subpart E, have been approved under
OMB control number 0910-0120; the collections of information in 21 CFR
part 814, subparts A through E, have been approved under OMB control
number 0910-0231; the collections of information in 21 CFR part 820
have been approved under OMB control number 0910-0073; the collections
of information in 21 CFR part 830 have been approved under OMB control
number 0910-0720; and the collections of information in 21 CFR parts
800, 801 and 809 have been approved under OMB control number 0910-0485.
    The labeling provisions in proposed Sec.  878.4850(a)(2)(vi),
(b)(2)(vi), and (c)(2)(vii) are not subject to review by OMB because
they do not constitute a ``collection of information'' under the PRA.
Rather, the following labeling: (1) ``For use only on a single patient.
Discard the entire device after use.''; (2) ``For use only on a single
patient. Disinfect reusable components according to manufacturer's
instructions between each use.''; (3) ``Used lancet blades must be
safely discarded after a single use.''; (4) ``Warning: Not intended for
more than one use. Do not use on more than one patient. Improper use of
blood lancets can increase the risk of inadvertent transmission of
bloodborne pathogens, particularly in settings where multiple patients
are tested.''; and (5) ``Warning: Do not use on more than one patient.
Improper use of blood lancets can increase the risk of inadvertent
transmission of bloodborne pathogens, particularly in settings where
multiple patients are tested. The cleaning and disinfection
instructions for this device are intended only to reduce the risk of
local use site infection; they cannot render this device safe for use
for more than one patient.'' are a ``public disclosure of information
originally supplied by the Federal Government to the recipient for the
purpose of disclosure to the public'' (5 CFR 1320.3(c)(2)).

X. References

    The following references marked with an asterisk (*) are on display
at the

Dockets Management Staff (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>. and are
available for viewing by interested persons between 9 a.m. and 4 p.m.,
Monday through Friday; they also are available electronically at
https://www.regulations.gov. References without asterisks are not on
public display at https://www.regulations.gov because they have
copyright restriction. Some may be available at the website address, if
listed. References without asterisks are available for viewing only at
the Dockets Management Staff. FDA has verified the website addresses,
as of the date this document publishes in the Federal Register, but
websites are subject to change over time.

1. *FDA Guidance for Industry and FDA Staff, ``Self-Monitoring Blood
Glucose Test Systems for Over-the-Counter Use,'' September 2020,
available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/self-monitoring-blood-glucose-test-systems-over-counter-use.
2. *Executive Summary, Transcript and other meeting material of the
June 26, 2013, meeting of the General and Plastic Surgery Devices
Panel available at https://wayback.archive-it.org/7993/20170405193132/https:/www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/GeneralandPlasticSurgeryDevicesPanel/ucm349426.htm.
3. *FDA Guidance for Industry and FDA Staff, ``Reprocessing Medical
Devices in Health Care Settings: Validation Methods and Labeling,''
March 17, 2015, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reprocessing-medical-devices-health-care-settings-validation-methods-and-labeling.
4. *FDA Guidance for Industry and FDA Staff, ``Blood Glucose
Monitoring Test Systems for Prescription Point-of-Care Use,''
September 2020, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/blood-glucose-monitoring-test-systems-prescription-point-care-use.
5. *The World Health Organization (WHO) Guidelines on Drawing Blood:
Best Practices in Phlebotomy, Part II, 2, Geneva: World Health
Organization, 2010, available at https://www.ncbi.nlm.nih.gov/books/NBK138665/.
6. Clinical Laboratory Standards Institute (CLSI), GP42 7th Edition,
Collection of Capillary Blood Specimens.
7. *FDA Guidance for Industry and FDA Staff, ``Submission and Review
of Sterility Information in Premarket Notification (510(k))
Submissions for Devices Labeled as Sterile,'' January 21, 2016,
available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-and-review-sterility-information-premarket-notification-510k-submissions-devices-labeled.
8. *FDA Guidance for Industry and FDA Staff, ``Use of International
Standard ISO 10993-1, Biological Evaluation of Medical Devices--Part
1: Evaluation and Testing Within a Risk Management Process,''
September 2020, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and.
9. *``Procedures for Class II Device Exemptions from Premarket
Notification,'' Guidance for Industry and CDRH Staff (Class II
510(k) Exemption Guidance), February 19, 1998, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/procedures-class-ii-device-exemptions-premarket-notification-guidance-industry-and-cdrh-staff.
10. *FDA Guidance for Industry and FDA Staff, ``Bundling Multiple
Devices or Multiple Indications in a Single Submission,'' June 20,
2007, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/bundling-multiple-devices-or-multiple-indications-single-submission.

List of Subjects in 21 CFR Part 878

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
878 is amended as follows:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for part 878 continues to read as follows:

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

0
2. Amend Sec.  878.4800 by revising paragraph (a) to read as follows:

Sec.  878.4800   Manual surgical instrument for general use.

    (a) Identification. A manual surgical instrument for general use is
a nonpowered, hand-held, or hand manipulated device, either reusable or
disposable, intended to be used in various general surgical procedures.
The device includes the applicator, clip applier, biopsy brush, manual
dermabrasion brush, scrub brush, cannula, ligature carrier, chisel,
clamp, contractor, curette, cutter, dissector, elevator, skin graft
expander, file, forceps, gouge, instrument guide, needle guide, hammer,
hemostat, amputation hook, ligature passing and knot-tying instrument,
knife, mallet, disposable or reusable aspiration and injection needle,
disposable or reusable suturing needle, osteotome, pliers, rasp,
retainer, retractor, saw, scalpel blade, scalpel handle, one-piece
scalpel, snare, spatula, stapler, disposable or reusable stripper,
stylet, suturing apparatus for the stomach and intestine, measuring
tape, and calipers. A surgical instrument that has specialized uses in
a specific medical specialty is classified in separate regulations in
parts 868 through 892 of this chapter.
* * * * *

0
3. Add Sec.  878.4850 to subpart E to read as follows:

Sec.  878.4850  Blood lancets.

    (a) Single use only blood lancet with an integral sharps injury
prevention feature--(1) Identification. A disposable blood lancet
intended for a single use that is comprised of a single use blade
attached to a solid, non-reusable base (including an integral sharps
injury prevention feature) that is used to puncture the skin to obtain
a drop of blood for diagnostic purposes. The integral sharps injury
prevention feature allows the device to be used once and then renders
it inoperable and incapable of further use.
    (2) Classification. Class II (special controls). The special
controls are:
    (i) The design characteristics of the device must ensure that the
structure and material composition are consistent with the intended use
and must include a sharps injury prevention feature.
    (ii) Mechanical performance testing must demonstrate that the
device will withstand forces encountered during use and that the
integral sharps injury prevention feature will irreversibly disable the
device after one use.
    (iii) The device must be demonstrated to be biocompatible.
    (iv) Sterility testing must demonstrate the sterility of any device
component that breaches the skin (e.g., blade).
    (v) Labeling must include:
    (A) Detailed descriptions, with illustrations, of the proper use of
the device and its sharps injury prevention feature.
    (B) Handwashing instructions for the user before and after use of
the device.
    (C) Instructions on preparation (e.g., cleaning, disinfection) of
the skin to be pierced.
    (D) Instructions for the safe disposal of the device.
    (E) Labeling must be appropriate for the intended use environment.
    (1) For those devices intended for health care settings, labeling
must address the health care facility use of these devices, including
how these lancets are to be used with personal protective equipment,
such as gloves.

    (2) For those devices intended for use in the home, labeling must
be written so that it is understandable to lay users.
    (vi) Labeling must also include the following statements,
prominently placed:
    (A) ``For use only on a single patient. Discard the entire device
after use.''
    (B) ``Warning: Not intended for more than one use. Do not use on
more than one patient. Improper use of blood lancets can increase the
risk of inadvertent transmission of bloodborne pathogens, particularly
in settings where multiple patients are tested.''
    (b) Single use only blood lancet without an integral sharps injury
prevention feature--(1) Identification. A disposable blood lancet
intended for a single use that is comprised of a single use blade
attached to a solid, non-reusable base that is used to puncture the
skin to obtain a drop of blood for diagnostic purposes.
    (2) Classification. Class II (special controls). The special
controls are:
    (i) The design characteristics of the device must ensure that the
structure and material composition are consistent with the intended use
and address the risk of sharp object injuries and bloodborne pathogen
transmissions.
    (ii) Mechanical performance testing must demonstrate that the
device will withstand forces encountered during use.
    (iii) The device must be demonstrated to be biocompatible.
    (iv) Sterility testing must demonstrate the sterility of any device
component that breaches the skin (e.g., blade).
    (v) Labeling must include:
    (A) Detailed descriptions, with illustrations, of the proper use of
the device.
    (B) Handwashing instructions for the user before and after use of
the device.
    (C) Instructions on preparation (e.g., cleaning, disinfection) of
the skin to be pierced.
    (D) Instructions for the safe disposal of the device.
    (E) Labeling must be appropriate for the intended use environment.
    (1) For those devices intended for health care settings, labeling
must address the health care facility use of these devices, including
how these lancets are to be used with personal protective equipment,
such as gloves.
    (2) For those devices intended for use in the home, labeling must
be written so that it is understandable to lay users.
    (vi) Labeling must also include the following statements,
prominently placed:
    (A) ``For use only on a single patient. Discard the entire device
after use.''
    (B) ``Warning: Not intended for more than one use. Do not use on
more than one patient. Improper use of blood lancets can increase the
risk of inadvertent transmission of bloodborne pathogens, particularly
in settings where multiple patients are tested.''
    (c) Multiple use blood lancet for single patient use only--(1)
Identification. A multiple use capable blood lancet intended for use on
a single patient that is comprised of a single use blade attached to a
solid, reusable base that is used to puncture the skin to obtain a drop
of blood for diagnostic purposes.
    (2) Classification. Class II (special controls). The special
controls are:
    (i) The design characteristics of the device must ensure that:
    (A) The lancet blade can be changed with every use, either manually
or by triggering a blade storage unit to discard the used blade and
reload an unused blade into the reusable base; and
    (B) The structure and material composition are consistent with the
intended use and address the risk of sharp object injuries and
bloodborne pathogen transmissions and allow for validated cleaning and
disinfection.
    (ii) Mechanical performance testing must demonstrate that the
device will withstand forces encountered during use.
    (iii) The device must be demonstrated to be biocompatible.
    (iv) Sterility testing must demonstrate the sterility of any device
component that breaches the skin (e.g., blade).
    (v) Validation testing must demonstrate that the cleaning and
disinfection instructions are adequate to ensure that the reusable
lancet base can be cleaned and low level disinfected.
    (vi) Labeling must include:
    (A) Detailed descriptions, with illustrations, of the proper use of
the device.
    (B) The Environmental Protection Agency (EPA) registered
disinfectant's contact time for disinfectant use.
    (C) Handwashing instructions for the user before and after use of
the device.
    (D) Instructions on preparation (e.g., cleaning, disinfection) of
the skin to be pierced.
    (E) Instructions on the cleaning and disinfection of the device.
    (F) Instructions for the safe disposal of the device.
    (G) Instructions for use must address the safe storage of the
reusable blood lancet base between uses to minimize contamination or
damage and the safe storage and disposal of the refill lancet blades.
    (H) Labeling must be appropriate for the intended use environment.
    (1) For those devices intended for health care settings, labeling
must address the health care facility use of these devices, including
how these lancets are to be used with personal protective equipment,
such as gloves.
    (2) For those devices intended for use in the home, labeling must
be written so that it is understandable to lay users.
    (vii) Labeling must also include the following statements,
prominently placed:
    (A) ``For use only on a single patient. Disinfect reusable
components according to manufacturer's instructions between each use.''
    (B) ``Used lancet blades must be safely discarded after a single
use.''
    (C) ``Warning: Do not use on more than one patient. Improper use of
blood lancets can increase the risk of inadvertent transmission of
bloodborne pathogens, particularly in settings where multiple patients
are tested. The cleaning and disinfection instructions for this device
are intended only to reduce the risk of local use site infection; they
cannot render this device safe for use for more than one patient.''
    (d) Multiple use blood lancet for multiple patient use--(1)
Identification. A multiple use capable blood lancet intended for use on
multiple patients that is comprised of a single use blade attached to a
solid, reusable base that is used to puncture the skin to obtain a drop
of blood for diagnostic purposes.
    (2) Classification. Class III (premarket approval).

    Dated: November 16, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-25376 Filed 11-19-21; 8:45 am]
BILLING CODE 4164-01-P