[Federal Register Volume 83, Number 160 (Friday, August 17, 2018)]
[Rules and Regulations]
[Pages 40973-40985]
[FR Doc No: 2018-17770]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 803

[Docket No. FDA-2017-N-6730]

Medical Devices and Device-Led Combination Products; Voluntary
Malfunction Summary Reporting Program for Manufacturers

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; order granting alternative.

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SUMMARY: The Food and Drug Administration's (FDA, Agency, or we) Center
for Devices and Radiological Health and Center for Biologics Evaluation
and Research are announcing that the Agency is granting an alternative
that permits manufacturer reporting of certain device malfunction
medical device reports (MDRs) in summary form on a quarterly basis. We
refer to this alternative as the ``Voluntary Malfunction Summary
Reporting Program.'' This voluntary program reflects goals for
streamlining malfunction reporting outlined in the commitment letter
agreed to by FDA and industry and submitted to Congress, as referenced
in the Medical Device User Fee Amendments of 2017 (MDUFA IV Commitment
Letter).

DATES: This voluntary program applies only to reportable malfunction
events that manufacturers become aware of on or after August 17, 2018.
See further discussion in section IV.F. ``Submission Schedule and
Logistics.''

FOR FURTHER INFORMATION CONTACT: Michelle Rios, Center for Devices and
Radiological Health (CDRH), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3222, Silver Spring, MD 20993, 301-796-
6107, [email protected]; or Stephen Ripley, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-
7911; or CBER, Office of Communication, Outreach, and Development
(OCOD), 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD
20993-0002; or by calling 1-800-835-4709 or<PHONE_NUMBER>; or email:
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Every year, FDA receives hundreds of thousands of MDRs of suspected
device-associated deaths, serious injuries, and malfunctions. The
Agency's MDR program is one of the postmarket surveillance tools FDA
uses to monitor device performance, detect potential device-related
safety issues, and contribute to benefit-risk assessments. Malfunction
reports represent a substantial fraction of the MDRs FDA receives on an
annual basis.
    Medical device reporting requirements for manufacturers are set
forth in section 519 of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360i) and the regulations contained in part 803 (21 CFR
part 803). Among other things, part 803 requires the submission of an
individual MDR when a manufacturer becomes aware of information, from
any source, which reasonably suggests that one of its marketed devices
malfunctioned and the malfunction of the device or a similar device
marketed by the manufacturer would be likely to cause or contribute to
a death or serious injury if the malfunction were to recur (Sec. Sec.
803.10(c)(1) and 803.50(a)(2). Throughout this document, we refer to
such malfunctions as ``reportable malfunctions'' or ``reportable
malfunction events.''
    The Food and Drug Administration Amendments Act of 2007 (FDAAA)

(Pub. L. 110-85) amended section 519(a) of the FD&C Act related to the
reporting of device malfunctions. FDAAA did not alter the malfunction
reporting requirements for class III devices and those class II devices
that are permanently implantable, life supporting, or life sustaining.
Under section 519(a)(1)(B)(i) of the FD&C Act, as amended by FDAAA,
manufacturers of those devices must continue to submit malfunction
reports in accordance with part 803 (or successor regulations), unless
FDA grants an exemption or variance from, or an alternative to, a
requirement under such regulations under Sec.  [thinsp]803.19. However,
FDAAA amended the FD&C Act to require that malfunction MDRs for class I
and those class II devices that are not permanently implantable, life
supporting, or life sustaining--other than any type of class I or II
device that FDA has, by notice, published in the Federal Register or by
letter to the person who is the manufacturer or importer of the device,
indicated should be subject to part 803 in order to protect the public
health--be submitted in accordance with the criteria established by
FDA. The criteria require the malfunction reports to be in summary form
and made on a quarterly basis (section 519(a)(1)(B)(ii) of the FD&C
Act). In the Federal Register of March 8, 2011 (76 FR 12743), FDA
explained that, pending further notice from the Agency, all class I
devices and those class II devices that are not permanently
implantable, life supporting, or life sustaining would remain subject
to individual reporting requirements under part 803 to protect the
public health, pursuant to section 519(a)(1)(B)(i)(III) of the FD&C
Act. Consequently, unless granted an exemption, variance, or
alternative, manufacturers of those devices have continued to be
required to submit individual malfunction reports under part 803. Under
Sec.  803.19, FDA may grant exemptions or variances from, or
alternatives to, any or all of the reporting requirements in part 803,
and may change the frequency of reporting to quarterly, semiannually,
annually, or other appropriate time period. FDA may grant such
modifications upon request or at its discretion, and when granting such
modifications, FDA may impose other reporting requirements to ensure
the protection of the public health. (See Sec.  803.19(c))
    In the Federal Register of December 26, 2017 (82 FR 60922), FDA
issued a notification outlining FDA's proposal to grant an alternative
under Sec.  803.19 to permit manufacturer reporting of certain device
malfunctions in summary form on a quarterly basis, subject to certain
conditions, and requested comments (2017 Proposal). As explained in the
2017 Proposal, the Voluntary Malfunction Summary Reporting Program is
intended to reflect goals for streamlining malfunction reporting that
FDA and industry agreed to in the MDUFA IV Commitment Letter (Ref. 1).
The 2017 Proposal also summarized FDA's previous experience with
summary reporting programs, key findings from an FDA pilot program for
the submission of MDRs in summary format on a quarterly basis (see 80
FR 50010, August 18, 2015), additional background regarding the
development of the proposal, and the anticipated benefits of summary
reporting under the proposal. Interested persons were given the
opportunity to submit comments by February 26, 2018.

II. Comments on the Proposed Alternative and FDA's Response

    In response to the 2017 Proposal, FDA received 24 comments from
industry, professional societies, trade organizations, and individual
consumers by the close of the comment period, each containing one or
more comments on one or more issues. A summary of the comments to the
docket and our responses follow. To make it easier to identify comments
and our responses, the word ``Comment'' appears in parentheses before
the comment's description, and the word ``Response'' in parentheses
precedes the response. The comments are grouped based on common themes
and numbered sequentially.

A. General Comments

    (Comment 1) Three comments suggested that the proposal was
inconsistent with amendments made by section 227 of FDAAA to section
519(a) of the FD&C Act regarding malfunction reporting requirements.
Two of these comments specifically recommended that FDA immediately
implement summary, quarterly malfunction reporting under section
519(a)(1)(B)(ii) of the FD&C Act for all class I devices and those
class II devices that are not permanently implantable, life supporting,
or life sustaining.
    (Response 1) FDA disagrees with these comments. As discussed in the
2017 Proposal, currently, there are still reportable malfunctions for
which submission of individual malfunction reports on a prompter basis
than quarterly is necessary to protect the public health--for example,
when remedial action is needed to prevent an unreasonable risk of
substantial harm to the public health. Those situations may involve
class I devices and class II devices that are not permanently
implantable, life supporting, or life sustaining, and it is not
feasible for FDA to provide notice in the Federal Register or by letter
to individual manufacturers, pursuant to section 519(a)(1)(B)(i)(III)
of the FD&C Act, each time one of these situations arises. For example,
FDA may not become aware of the situation until it receives an MDR from
a manufacturer. Therefore, in accordance with section
519(a)(1)(B)(i)(III) of the FD&C Act, manufacturers of class I devices
and those class II devices that are not permanently implantable, life
supporting, or life sustaining remain subject to individual reporting
requirements in part 803, unless granted an exemption, variance, or
alternative, to protect the public health. However, FDA does believe
that malfunction summary reporting on a quarterly basis, in accordance
with the conditions described in section IV, will reduce burden on FDA
and manufacturers and allow FDA to effectively monitor many devices.
Accordingly, the Agency is granting an alternative under section
519(a)(1)(B)(i) of the FD&C Act and Sec.  803.19 to permit
manufacturers of those devices to submit summary, quarterly malfunction
reports, with certain conditions.
    (Comment 2) Several comments raised concerns that the proposed
program would be unable to provide FDA with critical information on
adverse event reporting. Many of the comments from individual consumers
also raised concerns that the proposed program would limit transparency
of malfunction event data that is publicly available to patients and
physicians, including transparency regarding the number of reported
malfunctions. However, another comment indicated that the proposed
program would minimize burden while maintaining patient safety. That
same comment further indicated that the proposed malfunction summary
reporting format would enhance public visibility into the events and
associated investigation compared to a format previously used for the
Alternative Summary Reporting (ASR) program.
    (Response 2) FDA disagrees with the comments suggesting that the
Voluntary Malfunction Summary Reporting Program will negatively affect
patient safety and the transparency of malfunction reports. Summary,
quarterly reporting in accordance with this program will result in some
malfunction reports being submitted to FDA and added to the publicly
available Manufacturer and User Facility Device Experience (MAUDE)
database later

than this occurs under FDA's current individual reporting requirements.
However, as explained in our 2017 Proposal, we believe this reporting
format and schedule will also yield benefits for FDA and the public,
such as helping FDA process malfunction reports more efficiently and
helping both FDA and the public more readily identify malfunction
trends.
    While summary malfunction reports submitted under this program will
change the format in which information is presented to FDA, we do not
believe there will be an adverse impact on the content of information
provided to FDA. The format for summary reporting described in section
IV.D includes a narrative section for describing malfunctions, similar
to the narrative section required for individual reporting. In
addition, each narrative section is required to include a sentence
specifying the number of malfunction events summarized in the report,
providing transparency for the public regarding the number of events
that a summary report available in MAUDE represents. Therefore, we
agree with the comment that the summary reporting format will improve
transparency for the public when compared to some past summary reports
submitted to FDA, such as reports submitted under the ASR program (Ref.
2).
    (Comment 3) One comment requested clarification as to whether a
manufacturer would need to apply or obtain permission to participate in
the program and asked FDA to clarify how the proposed program would
work with other alternative summary reporting situations. Another
comment asked FDA to clarify whether manufacturers can still apply for
an exemption or variance to be granted under Sec.  803.19 for their
devices that do not fall under an eligible product code.
    (Response 3) FDA is clarifying in the description of the
alternative that manufacturers do not need to submit a request or
application to FDA before participating in the Voluntary Malfunction
Summary Reporting Program. For devices that fall within eligible
product codes, the alternative that FDA is granting under Sec.  803.19
provides that manufacturers may choose or ``self-elect'' to
participate, subject to the program conditions identified in section
IV. If a manufacturer wishes to request a different exemption,
variance, or alternative under Sec.  803.19 (including for devices in
product codes that are eligible for the Voluntary Malfunction Summary
Reporting Program) the manufacturer may submit a request to FDA. For
more information regarding the recommended content of such requests,
see section 2.27 of the Agency's guidance entitled ``Medical Device
Reporting for Manufacturers: Guidance for Industry and Food and Drug
Administration Staff'' (MDR Guidance) (Ref. 3).
    Whether participation in the Voluntary Malfunction Summary
Reporting Program will have an impact on a manufacturer being granted a
different exemption, variance, or alternative under Sec.  803.19 will
depend on the scope of the other exemption, variance, or alternative.
FDA will make a case-by-case determination on requests for an
exemption, variance, or alternative submitted under Sec.  803.19(b).

B. Scope of Program

    (Comment 4) Several comments also discussed the scope of product
codes that should be eligible for the proposed program. One comment
expressed concern about including class III devices and class II
devices that are permanently implantable, life-supporting, or life-
sustaining in the program and urged FDA to issue another Federal
Register notice with the list of eligible product codes for these
categories of devices for public comment before allowing summary,
quarterly malfunction reporting for those devices. In contrast, another
comment asserted that all devices should be eligible for malfunction
summary reporting, unless there is an express determination, subject to
public input, that permitting summary reporting for a device would
present public health concerns. Other comments recommended that all
device product codes should be eligible for summary, quarterly
malfunction reporting, with the exception of product codes for class
III devices and class II devices that are permanently implantable, life
supporting, or life sustaining when those product codes have been in
existence for less than 2 years.
    (Response 4) FDA disagrees that it should publish another Federal
Register notice for public comment listing product codes that would be
eligible or ineligible for the program. Among other reasons, the Agency
expressly requested comment on the product codes that should be
eligible for the proposed program, and many commenters submitted
proposed lists of eligible product codes or identified specific devices
about which they had concerns. FDA has considered these comments and
has also conducted an extensive review of all product codes, regardless
of device class, to determine whether each product code would be
eligible. In addition, consistent with its 2017 Proposal, product codes
that have been in existence for less than 2 years are not included in
the list of eligible product codes, unless the new product code was
created solely for administrative reasons. In FDA's experience, this 2-
year period is an important period for having more timely, detailed
information to monitor malfunction events. That 2-year timeframe for
new product codes is also consistent with the MDUFA IV Commitment
Letter (Ref. 1).
    (Comment 5) Three comments recommended that importers be included
within the scope of the proposed program and indicated that FDA should
provide a rationale for not including them. One of those comments
suggested that without more information, it appeared arbitrary that FDA
did not include importers and user facilities in the summary reporting
program.
    (Response 5) FDA disagrees with these comments. Unlike
manufacturers, device user facilities are not required to submit
malfunction reports under part 803. User facilities, such as hospitals
or nursing homes, are required to submit MDRs to FDA and/or the
manufacturer only for reportable death or serious injury events. (See
section 519(b) of the FD&C Act; Sec.  803.30(a)).
    Importers are also subject to different requirements for reporting
device malfunctions than those for manufacturers under part 803. Under
Sec.  803.40, importers are required to submit a report to the device
manufacturer, not to FDA, within 30 days after becoming aware of a
reportable malfunction event. Manufacturers then determine the
reportability of the information received from the importer and
accordingly submit those reports to FDA. This program specifically
addresses malfunction summary reporting to FDA. In addition, we believe
it is important for importers to continue to submit individual
malfunction MDRs to device manufacturers in accordance with Sec.
803.40 so that manufacturers receive detailed information necessary to
conduct adequate investigations and follow up related to malfunction
events.

C. Individual Reporting Conditions

    (Comment 6) One comment suggested that when requesting that a
manufacturer submit a 5-day report, FDA should have an objective and
documented basis for making such a request, as well as an opportunity
for manufacturers to appeal. Other comments asked FDA to define the
term ``substantially similar'' as used in describing the program
condition regarding 5-day reports and to clarify

what constitutes an ``imminent hazard'' and whether this is analogous
to reportable malfunctions requiring a 5-day report.
    (Response 6) The circumstances in which a 5-day report is required
are defined under Sec.  803.53, and those circumstances remain
unchanged for manufacturers participating in the Voluntary Malfunction
Summary Reporting Program. As stated in the 2017 Proposal, the
reporting requirements at Sec.  803.53 will continue to apply to
manufacturers of devices in eligible product codes who participate in
this program. We have added a separate heading to the description of
the alternative to clarify this point further. For more information
regarding the handling of a 5-day report, please see section 2.20 of
the Agency's MDR Guidance (Ref. 3).
    The first individual reporting condition requires that if a
manufacturer submits a 5-day report for an event or events that require
remedial action to prevent an unreasonable risk of substantial harm to
public health, all subsequent reportable malfunctions of the same
nature that involve substantially similar devices must be submitted as
individual MDRs in accordance with Sec. Sec.  803.50 and 803.52 until
the date that the remedial action has been resolved to FDA's
satisfaction. For purposes of this individual reporting condition, a
``substantially similar'' device could be, for example, a device that
is the same except for certain performance characteristics or a device
that is the same except for certain cosmetic differences in color or
shape.
    Regarding the term ``imminent hazard,'' FDA notes that the term is
used to describe one of the general overarching principles for summary
reporting, but is not included in the descriptions of any of the
individual reporting conditions. For purposes of these overarching
principles, we intend ``imminent hazard'' to capture situations in
which a device poses a significant risk to health and creates a public
health situation that should be addressed immediately to prevent
injury. Use of that term in one of the overarching principles was not
intended to indicate any change in the standard for a 5-day report
under Sec.  803.53.
    (Comment 7) One comment indicated that there should be objective
and documented criteria for when FDA would provide written notice that
manufacturers must submit an individual, 30-day malfunction report in
accordance with the proposed program conditions, along with an
opportunity for appeal. The comment further asserted that due process
considerations need to be made regarding these reporting requirements,
including notice, a written justification for the request, and a
process to appeal.
    (Response 7) FDA disagrees that there should be fixed criteria for
notifying a manufacturer that it must submit an individual, 30-day
malfunction report in accordance with the program conditions.
Manufacturers who are notified to submit individual reports in
accordance with the individual reporting conditions will need to comply
with MDR requirements to which they would otherwise be subject if not
granted this alternative under Sec.  803.19. FDA has provided examples
of when it would make these notifications, but public health issues
that require submission of individual MDRs to monitor device safety are
not uniform and may arise in various ways.
    FDA will provide written notice to manufacturers when they need to
submit individual MDRs pursuant to individual reporting conditions 3
and 4, as described in section IV.B. In addition, the Agency already
has a process in place for stakeholders to request review of decisions
made by CDRH employees. For more information, refer to the FDA Guidance
entitled ``Center for Devices and Radiological Health Appeals
Processes'' (Ref. 4).
    (Comment 8) Some comments disagreed with the proposed program
condition that would have required manufacturers to submit individual,
30-day MDRs for reportable malfunction events that are the subject of
any ongoing device recall and suggested that the condition be modified
or removed. The comments cited several different reasons for objecting
to this condition, including that the condition is not mentioned in the
MDUFA IV Commitment Letter, that the condition may discourage
manufacturers from conducting voluntary or class III recalls, that the
condition is duplicative of information that FDA receives during a
recall, and that it may be difficult for manufacturers to manage the
requirements (e.g., new events may be uncovered during a product
investigation leading to confusion and multiple reports for the same
incident). Suggestions from the commenters regarding this individual
reporting condition included the following: (a) The condition should
only apply to mandatory or FDA-initiated recalls, and summary reporting
should be permitted for voluntary or low-risk class III recalls and for
incidents related to remedial action after the first (parent) MDR is
submitted, unless a death or serious injury is associated; (b) FDA
should clarify how to handle malfunction events that were not submitted
as individual MDRs, but subsequently, prior to the next summary
reporting date, are identified to be the result of an issue addressed
by a recall; (c) the timeframe for submitting individual MDRs should be
changed from 90 days past the date of the termination of the recall to
90 days past the date of the recall; and (d) FDA should clarify what it
means by ``malfunction events of the same nature.''
    (Response 8) FDA disagrees with the comments recommending removal
of this individual reporting condition. Recall classification takes
into account both the severity of harm and the likelihood of
occurrence, and it is important for FDA to have access to more timely
information on malfunctions related to certain recalls to ensure that
the recall has been appropriately classified and that the recall
strategy is effective.
    FDA also provides the following responses to the additional
specific issues raised in the comments: (a) For the reasons discussed
above, FDA continues to believe that it is important for malfunctions
related to certain recalls to be reported as individual MDRs. However,
after considering the comments, FDA has determined that this individual
reporting condition should only apply to reportable malfunctions that
are the subject of a recall involving a correction or removal that must
be reported to FDA under part 806 (21 CFR part 806). Under part 806,
manufacturers and importers are required to make a written report to
FDA of any correction or removal of a device if the correction or
removal was initiated to reduce a risk to health posed by the device or
to remedy a violation of the FD&C Act caused by the device that may
present a risk to health, unless the information has already been
submitted to FDA in accordance with other reporting requirements. (See
Sec.  806.10(a) and (f).) Because the definition of ``risk to health''
under part 806 tracks the definitions of class I and class II recalls
in Sec.  7.3(m) (21 CFR 7.3(m)), reports of corrections and removals
are required for actions that meet the definition of class I and class
II recalls. However, under part 806, manufacturers and importers need
not report events that are categorized as class III recalls under Sec.
7.3(m) (see 62 FR 27183, May 19, 1997). Therefore, an action that meets
the definition of a class III recall would not, on its own, trigger the
requirement to submit individual reports under the Voluntary
Malfunction Summary Reporting Program.

    (b) FDA agrees that it is important to provide clarity regarding
when the requirement to submit individual MDRs is triggered under this
individual reporting condition and the events to which that requirement
applies. Therefore, FDA is revising the alternative to clarify that, as
of the date a manufacturer submits a required report of a correction or
removal under part 806 (or the date that the manufacturer submits a
report of the correction or removal under 21 CFR part 803 or part 1004
instead, as permitted under Sec.  806.10(f)), the manufacturer must
submit reportable malfunction events related to that correction or
removal as individual MDRs in accordance with Sec. Sec.  803.50 and
803.52. We believe these revisions will help provide manufacturers with
a clear date on which this individual reporting obligation is
triggered.
    With respect to malfunction events that were identified for
inclusion in a summary report but are subsequently identified as the
subject of a reportable correction or removal prior to the end of the
relevant summary reporting period, FDA is revising the alternative to
state that a summary MDR must be submitted for those reportable
malfunctions within 30 calendar days of when the manufacturer submits
the required report of correction or removal. In the summary report,
the manufacturer must include a check on the box for ``Recall'' in
SECTION H.7 of the electronic Form FDA 3500A. We have similarly revised
the description of individual reporting conditions 3 and 4 to clarify
the requirements for handling malfunction events identified for
inclusion in a summary report (but not yet submitted) prior to the date
that individual reporting is triggered.
    (c) As part of its recall termination process, FDA considers MDR
information, including reported malfunctions to help evaluate the
effectiveness of the recall. Therefore, FDA disagrees with the
suggestion to limit the duration of individual reporting under this
condition to 90 days past the date of a recall. However, after
considering the comments, we do not believe it is necessary to receive
individual MDRs for reportable malfunction events that are the subject
of a recall after FDA has terminated the recall. We have revised the
alternative accordingly (see Section IV.B.2.). For similar reasons, we
have revised the first individual reporting condition to state that
individual MDRs associated with a 5-day report are only required until
the remedial action at issue is resolved to FDA's satisfaction.
    (d) By ``malfunction events of the same nature,'' FDA means
additional reportable malfunction events involving the same malfunction
that prompted the recall.
    (Comment 9) One comment, regarding proposed individual reporting
condition 3, suggested that FDA provide information on the timing for
when the Agency will provide written notice to a manufacturer that the
manufacturer can resume participation in the Voluntary Malfunction
Summary Reporting Program.
    (Response 9) FDA cannot provide a uniform timeframe for when the
Agency would notify manufacturers submitting individual reports due to
an identified public health issue that they can resume submission of
summary, quarterly malfunction reports for those devices because the
timing and resolution of public health issues is specific to each
situation.
    (Comment 10) Three comments recommended that FDA clarify what
constitutes a ``new type of reportable malfunction'' that is exempt
from summary reporting. One of these comments indicated that FDA should
provide additional information regarding when a manufacturer can begin
submitting summary reports for these new types of device malfunctions.
    (Response 10) FDA disagrees that the meaning of the phrase ``new
type of reportable malfunction'' was unclear in the proposal.
Manufacturers are required under Sec.  820.198 (21 CFR 820.198) to
evaluate complaints to determine if they represent events that must be
reported to FDA under part 803 or if an investigation is required.
Through this process, if a manufacturer identifies a new type of
reportable malfunction that has not previously been reported to FDA
over the life of that device, this information must be submitted to FDA
as an individual MDR in accordance with Sec. Sec.  803.50 and 803.52
and may not be reported to FDA in a summary malfunction report. This
will allow FDA and manufacturers to better understand and address
emergent issues with medical devices. We have revised this individual
reporting condition to clarify that after manufacturers submit an
individual MDR for the initial occurrence of a previously unreported
type of reportable malfunction for a device, subsequent reports for
that same type of malfunction for that device may be in summary form,
unless they are subject to individual reporting for another reason.

D. Reporting Format

    (Comment 11) Some comments suggested that FDA allow manufacturers
to ``bundle together'' reportable malfunction events in a summary
report by product code or product family and allow the use of
International Medical Device Regulators Forum's (IMDRF) Level 1,2 codes
to bundle like events in a summary report.
    (Response 11) FDA disagrees with the suggestion that manufacturers
be permitted to bundle reportable malfunction events by product code or
product family for purposes of submitting a summary report. Each unique
combination of device brand name (corresponding to SECTION D1 of the
Form FDA 3500A), device model, and device problem code(s)
(corresponding to SECTION F10/H6 of the Form FDA 3500A) can be
summarized together in reports submitted under this program. (Comments
regarding the number of brand names that should be included in each
summary report are further addressed in the response to Comment 16
below, and we have made corrections to the summary reporting
instructions for SECTION D.4 to be clear that each summary malfunction
report should summarize events for a single device model.) Bundling
together malfunction reports by product codes or device families would
make summarizing and interpreting the information in a summary report
difficult for manufacturers, FDA, and the public because a product code
or product family could contain several devices with different
functions, components, and modes of operation that are important for
purposes of understanding malfunction events and the causes of those
events. The intent of the Voluntary Malfunction Summary Reporting
Program is to streamline reporting of events that are the same or
similar, yet not to over bundle reports such that important details
regarding device performance are obscured.
    The IMDRF (Ref. 5) is working towards harmonization of all medical
device coding, including device problem codes. To harmonize medical
device coding globally, device problem codes have been organized in a
hierarchical arrangement, such that higher level codes (e.g.,
electrical issue) describe more general device problems, while lower
level codes (e.g., insulation issue) provide more granularity into the
type of device problem described. For purposes of grouping device
issues for reports submitted under this Voluntary Malfunction Summary
Reporting Program, we recommend that all coding

be grouped at the lowest level of coding available, when IMDRF codes
are available. Based on our experience, FDA does not believe grouping
by the lowest level of coding will eliminate the efficiency benefits of
summary reporting. FDA does not specify a specific level of coding, but
expects the most specific appropriate code to be used.
    (Comment 12) One comment noted that it was unclear whether a
summary malfunction report will be available in MAUDE or another
database. Another comment recommended that FDA allow Excel spreadsheets
with malfunction report data to be uploaded to MAUDE.
    (Response 12) FDA plans to make summary reports submitted under the
Voluntary Malfunction Summary Reporting Program publicly available in
MAUDE. However, FDA will not upload Excel spreadsheets to MAUDE because
they are incompatible with the MAUDE interface.
    (Comment 13) One comment indicated that FDA should consider
amending the requirement that an individual process the complaints
twice--once for reporting assessment and then quarterly.
    (Response 13) FDA disagrees with this comment. FDA is granting an
alternative to the individual reporting requirements under part 803 for
certain reportable malfunction events. The Quality System (QS)
regulation requires manufacturers to evaluate all complaints to
determine if they represent events that must be reported to FDA under
part 803 (Sec.  820.198(a)). If a complaint represents an MDR
reportable event, then the manufacturer must, among other things,
investigate it and submit an MDR to FDA. (See Sec. Sec.  803.10(c),
803.50, and 820.198(d)) The difference for manufacturers that have been
granted the alternative described in this document is that they could
choose to report certain malfunction events to FDA as a summary report
instead of as an individual report.
    (Comment 14) One comment requested that FDA provide more detail
concerning the terms ``similar device'' and ``similar complaint,'' as
used in the discussion of the rationale for the proposed summary
reporting format.
    (Response 14) The term ``similar device'' is used in FDA's MDR
regulations to describe malfunction events for which manufacturers must
submit a report to FDA. (see e.g., Sec.  803.50(a)(2)) As used in this
alternative, the term ``similar device'' is intended to have the same
meaning as it does for purposes of part 803. FDA's MDR Guidance (Ref.
3), provides more information regarding the factors that FDA and
manufacturers may consider in determining if a device is ``similar'' to
another device.
    FDA does not believe it is necessary to provide a formal definition
of the term ``similar complaint'' for purposes of this alternative
because that term is not used in describing any of the conditions of
the Voluntary Malfunction Summary Reporting Program, including the
required reporting format. Whether a complaint constitutes a ``similar
complaint'' for purposes of conducting an investigation under FDA's QS
regulation is outside the scope of this alternative.
    (Comment 15) One comment asked FDA to provide further information
on how a manufacturer is to provide supplemental information, including
whether FDA expects such information to be shared with the Agency. Some
comments also noted that FDA should explain how a previously submitted
summary malfunction report should be updated with new information,
including how to handle new information regarding a previously reported
event that would change the categorization of the event (e.g., if the
manufacturer subsequently became aware that a serious injury was
associated with a previously reported malfunction event).
    (Response 15) FDA understands the need for clarification of how to
handle additional information and supplemental reporting under this
program and has revised the alternative to address this issue. A
manufacturer participating in the Voluntary Malfunction Summary
Reporting Program must submit an initial summary report within the
Summary Malfunction Reporting Schedule timeframe described in table 1.
Supplemental reports to a summary malfunction report must also be
submitted within that timeframe. For example, if a manufacturer submits
a summary report for certain malfunction events of which it became
aware in January to March and in May of that same year becomes aware of
additional information that would have been required in the initial
summary report if it had been known to the manufacturer, then the
manufacturer must submit a supplemental report with that additional
information by July 31. Manufacturers do not need to submit a
supplemental report for new information if they would not have been
required to report that information had it been known or available at
the time of filing the initial summary malfunction report.
    However, this timing for supplemental reports would not apply when
additional information is learned about an event or events included in
a previously submitted summary report that triggers individual
reporting requirements. For example, if the manufacturer becomes aware
of additional information reasonably suggesting that a previously
reported malfunction meets the criteria for a reportable serious injury
or death event, then the manufacturer must submit an initial,
individual MDR for the identified serious injury or death within 30
calendar days of becoming aware of the additional information. The
manufacturer must simultaneously submit a supplement to the initial MDR
summary report reducing the number of events summarized by 1, so that
the total number of events remains the same. The alternative has been
revised to reflect that these are requirements for participating in the
Voluntary Malfunction Summary Reporting Program.
    (Comment 16) One comment stated that Form FDA 3500A is not an
optimal format because it is only used for single event reporting.
Other comments made specific recommendations and/or raised issues
regarding the proposed summary reporting format using Form FDA 3500A,
including the following: (a) In Form FDA 3500A, SECTIONS B.5 and H.10,
FDA should request that information be entered in a summary, high-level
form, rather than requiring detailed descriptions or itemized
investigation findings; (b) clarify the most ``up to date'' information
that is expected to be received in the report; (c) clarify that only
one brand name per product code should be entered in the field with
additional brand names being provided in a separate attachment (SECTION
D.1); (d) inclusion of patient age, weight, and breakdown of gender and
race is inappropriate for summary malfunction reporting, and it is not
clear if such information is required in a summary malfunction report;
(e) clarify that manufacturers can submit summary malfunction reports
for devices manufactured at multiple manufacturing sites (SECTION D.3);
(f) the summary format should permit a serial number to be used instead
of a lot number to identify the devices that are the subject of a
summary report (SECTION D.4); and (g) address how a manufacturer should
link a device problem code with a method code, result code, and
evaluation conclusion code (if different) for a single summary report
that includes more than one device problem.
    (Response 16) FDA does not believe the summary reporting format
should be changed to use a new form. The

Voluntary Malfunction Summary Reporting Program aims to, among other
things, consolidate reporting of same or similar events into a single
summary report to reduce the overall volume of reports, while still
providing critical content to FDA. While the Form FDA 3500A was
developed for individual MDRs, manufacturers successfully used the Form
FDA 3500A to submit summary malfunction reports in FDA's pilot program.
In addition, as explained in our 2017 Proposal, for purposes of
streamlining changes that FDA and manufacturers must make to process or
submit summary reports under the Voluntary Malfunction Summary
Reporting Program, we believe that using the Form FDA 3500A is the most
efficient approach. We provide the following responses to the specific
recommendations/issues raised regarding the summary reporting format:
(a) FDA continues to believe that it is important for summary
malfunction reports submitted under this program to provide a similar
level of detail in text narratives as is available in an individual
report to allow for sufficient understanding of the malfunction, any
circumstances that led to the malfunction, and any follow-up steps the
manufacturer has taken to investigate, correct, and prevent the
malfunction from happening again. These narrative text fields are key
to helping ensure that summary reporting under this program streamlines
malfunction reporting without reducing the reporting of important
details regarding device performance and transparency to the public.
(b) Each summary report must be ``up to date,'' meaning that it must
include all required information available, as of the close of the
quarterly time period listed in the Summary Malfunction Reporting
Schedule (see table 1). FDA has clarified this in section IV.F. (c) FDA
disagrees that separate attachments with additional brand names should
be permitted to accompany a summary malfunction report. Each summary
malfunction report may only summarize malfunction events for a single
brand name. We further clarified this in the instructions for the
summary reporting format at section IV.D. Including multiple brand
names in an attachment to a single summary report would, among other
things, result in FDA having difficulty identifying the specific
malfunction event to the exact device brand. (d) FDA agrees that
information summarizing patient age, weight, gender, race, and
ethnicity may not be relevant for many summary malfunction reports. FDA
is revising the description of the summary reporting format to clarify
that inclusion of this information in Section B.5 is not a required
entry for the form. However, FDA recommends including descriptors such
as patient weight or race in a text narrative for a malfunction summary
report if the information is available and indicates that a malfunction
is more likely to affect a specific group of patients. (e) FDA is
revising the description of the summary reporting format to clarify
that multiple manufacturing sites could be entered in SECTION G.1 if
the device is manufactured at multiple sites. We note that depending on
their roles, each manufacturing site may be responsible for submitting
MDRs. (See e.g., section 2.17 of FDA's MDR Guidance (Ref. 3), which
provides additional information regarding reporting obligations for
contract manufacturers.) (f) FDA agrees that a serial number may be
included in SECTION D.4 and has added ``serial number'' to the
reporting format instructions for that section. (g) The summary
reporting format requires firms to identify the method, result, and
conclusion codes in Block H6 of the Form FDA 3500A, including as many
codes as are necessary to describe the event problem and evaluation for
the reportable malfunction events that are being summarized. If the
report summarizes reportable events that involved more than one type of
device problem (see e.g., Case Scenario #2, Report #3 in Appendix A
(Ref. 6)), differences in the conclusion code according to the
different device problems can be explained in SECTION H.10.

E. Consideration of Combination Products

    (Comment 17) Some comments raised issues regarding the application
of the malfunction summary reporting for combination products that
contain a device constituent part but that are marketed under drug or
biological product marketing authorization pathways (referred to in
this document as drug and biologic-led combination products), as
opposed to those under device marketing authorization pathways (device-
led combination products). Issues raised in these comments include:
Concerns about a device product code-based eligibility approach for
drug and biologic-led combination products because such products may
not have a device product code; the quarterly schedule proposed because
it would create redundancies for drug and biologic-led combination
products, which are subject to periodic reporting; the format proposed
because it might not be compatible with the reporting systems for drugs
or biological products that are utilized for drug and biologic-led
combination products; and development of a single report that includes
malfunction summary reporting and satisfies other combination product
reporting requirements.
    (Response 17) Among other things, the final rule on postmarketing
safety reporting (PMSR) for combination products (81 FR 92603, December
20, 2016), codified in part 4, subpart B (21 CFR part 4, subpart B),
clarified that all combination product applicants must comply with
malfunction reporting requirements as described in part 803 if their
combination product contains a device constituent part. Accordingly, in
the 2017 Proposal, FDA requested comment on how the Voluntary
Malfunction Summary Reporting Program might be implemented for
combination products, including drug and biologic-led combination
products. Shortly after the issuance of the proposal for this program,
FDA also published a draft guidance entitled, ``Postmarketing Safety
Reporting for Combination Products; Guidance for Industry and FDA
Staff'' (PMSR draft guidance) (Ref. 7) regarding compliance with the
final rule on PMSR for combination products, and an Immediately in
Effect guidance announcing FDA's compliance policy for that rule (Ref.
8). The PMSR draft guidance noted that the Agency was proposing the
Voluntary Malfunction Summary Reporting Program and stated that the
Agency intends to update the PMSR draft guidance if combination
products are included in the program. The compliance policy guidance
announced the Agency's intent to delay enforcement of certain
provisions of the rule, including malfunction reporting requirements
for drug and biologic-led combination products, to provide applicants
with additional time to consider Agency recommendations and technical
specifications as they update their systems and procedures to comply
with those provisions.
    Applicants of device-led combination products must submit MDRs in
accordance with part 803 (see Sec.  4.104 (21 CFR 4.104)), and
therefore, they report malfunctions using the same system as device
manufacturers. Thus, FDA believes the eMDR data system and instructions
support use of the Voluntary Malfunction Summary Reporting Program for
such products. Accordingly, we are including device-led combination
products in the Voluntary Malfunction Summary Reporting Program.
However, combination product applicants for drug

and biologic-led combination products with a device constituent part
must submit malfunction reports under a different system. Under Sec.
4.104(b), malfunction reports must be submitted in accordance with 21
CFR 314.80(g) or 600.80(h)) for these combination products. Additional
considerations, including the issues raised in comments as discussed
above, need to be addressed before drug and biologic-led combination
products could be included in the Voluntary Malfunction Summary
Reporting Program. As noted above, the Agency intends to delay
enforcement of the malfunction reporting requirements for drug and
biologic-led combination products under the PMSR final rule. FDA will
consider all relevant comments submitted on the 2017 Proposal as well
as those submitted on the PMSR draft guidance in developing an approach
for voluntary malfunction summary reporting for such combination
products.

F. Submission Schedule and Logistics

    (Comment 18) One comment recommended that FDA permit manufacturers
to submit individual reports for each adverse event within 90 calendar
days from the date they become aware of the reportable event, while
using the summary format. The comment also suggested that FDA provide
an additional 30 days for the submission of summary reports because the
manufacturer may need more than a month between the end of the
reporting period and the due date to aggregate reports.
    (Response 18) FDA disagrees with this comment. Permitting
manufacturers to submit individual reports using the summary format
within 90 calendar days would delay the submission of malfunction
information to FDA without providing the anticipated benefits of
summary reporting that FDA identified in the 2017 Proposal, such as
increased efficiency in processing malfunction reports and more readily
apparent malfunction trends. While we recognize that a manufacturer may
become aware of some reportable malfunction events toward the end of a
quarter, manufacturers will have at least 30 days from that time to
prepare and submit summary malfunction reports. FDA does not believe
that manufacturers will need an additional 30 days beyond the reporting
schedule outlined in the 2017 Proposal to aggregate malfunction reports
into a summary report. Therefore, we have retained the Summary
Malfunction Reporting Schedule that was included in the 2017 Proposal
(see table 1).
    (Comment 19) One comment suggested that FDA use a more generic
reporting number format or a completely different reporting number
format.
    (Response 19) FDA disagrees with this comment. The required
reporting number format for this program uses the existing common
format that manufacturers must use to submit individual reports through
their electronic reporting systems under part 803. Therefore, we
believe there is no need for a separate MDR reporting number format to
identify summary reports.
    (Comment 20) One comment suggested that FDA clarify what the
manufacturer should do if an investigation is not completed within the
reported timeframe.
    (Response 20) As discussed in response to Comment 15, FDA has
revised the alternative to include instructions regarding supplemental
reporting for summary reports submitted under this voluntary program.
In situations where a manufacturer is not able to complete its
investigation regarding a reportable malfunction by the deadline for
submitting a summary report, the manufacturer is still required to
report the event within the timeframes specified in the Summary
Malfunction Reporting Schedule (see table 1). If additional information
becomes known or available to the manufacturer after submission of a
summary report, including additional information that becomes known
through an investigation, the manufacturer is required to submit
supplemental reports amending its initial submission as needed.

G. Addition of Product Codes to the Program

    (Comment 21) Some comments suggested that FDA should explain more
clearly how industry would make a request under Sec.  803.19(b) and
provide a mechanism for industry to request an exemption, when
appropriate, for product codes that may be newly assigned within the
first 2 years.
    (Response 21) FDA is not making any changes to the alternative in
response to this comment. As discussed in section VI, FDA intends to
periodically assess the eligibility of product codes after they have
been in existence for 2 years and will update the FDA's Product
Classification database accordingly. Manufacturers can also send a
request for a product code to be added to the list of eligible product
codes and for manufacturers of devices within that product code to be
granted the same alternative for malfunction events associated with
those devices. Information about where to send such requests is
provided in section VI.

H. Other Comments

    (Comment 22) One comment stated that the average Paperwork
Reduction Act (PRA) burden on manufacturers of 6 minutes per response
appears to be a very low estimate.
    (Response 22) FDA disagrees with this comment. The estimation of
time is the amount of time needed to submit a summary malfunction
report. It is essentially the same amount of time needed to submit an
individual report because the event narrative should be similar, with
the exception of one additional line that is entered that indicates the
number of adverse events represented by the report. It does not include
the time needed to evaluate and investigate complaints that may
represent reportable malfunction events.
    (Comment 23) Two comments suggested that FDA should provide clarity
on how the program will apply with national competent authorities via
the National Competent Authority Report (NCAR) exchange program.
    (Response 23) FDA disagrees with this comment. The NCAR exchange
program is separate from FDA's MDR reporting requirements. Malfunction
summary reporting under this program does not change the information
shared through the NCAR exchange program, and the NCAR program is
currently outside the scope of the Voluntary Malfunction Summary
Reporting Program.
    (Comment 24) One comment suggests that FDA should use IBM's Watson
Platform for Health GxP (Watson) to conduct an analysis to identify the
product codes that represent the largest opportunity described in the
business case for patients, industry, and FDA instead of other database
systems.
    (Response 24) FDA disagrees with this comment. Among other reasons,
the IBM Watson Platform is not an FDA-owned resource; therefore, it is
not logistically feasible for FDA to use this platform to identify
product codes eligible for the Voluntary Malfunction Summary Reporting
Program at this time.

III. Principles for Malfunction Summary Reporting

    Informed by the findings from the Pilot Program for Medical Device
Reporting on Malfunctions, FDA identified the following overarching
principles for summary reporting of malfunctions:
     The collection of information in summary format should
allow FDA to

collect sufficient detail to understand reportable malfunction events.
     To increase efficiency, summary malfunction reporting
should occur in a common format for the electronic reporting system
used.
     Information about reportable malfunctions should be
transparent to FDA and to the public, regardless of whether the
information is reported as an individual MDR or a summary report.
Information contained in a summary malfunction report that is protected
from public disclosure under applicable disclosure laws would be
redacted prior to release of the report.
     Manufacturers should communicate information regarding an
imminent hazard at the earliest time possible.
     Summary reporting is meant to streamline the process of
reporting malfunctions. It does not change regulatory requirements for
MDR-related investigations or recordkeeping by manufacturers. (For
example, manufacturers participating in the Voluntary Malfunction
Summary Reporting Program remain subject to requirements for
establishing and maintaining MDR event files under Sec.  803.18. In
addition, under the QS regulation, manufacturers must evaluate, review,
and investigate any complaint that represents an MDR reportable event
(see Sec.  820.198).
     Summary reporting information should not be duplicative of
information received through other MDR reporting processes.

IV. Voluntary Malfunction Summary Reporting Program

    For the reasons discussed in the 2017 Proposal and in section II,
the Agency has determined that, at this time, pursuant to section
519(a)(1)(B)(i)(III) of the FD&C Act, all devices should remain subject
to the reporting requirements of part 803, to protect the public
health. However, based on the findings from the 2015 Pilot Program, the
Agency's experience with summary reporting programs, its experience
with MDR reporting generally, and the comments received on 2017
Proposal, FDA has determined that for many devices, it is appropriate
to permit manufacturers to submit malfunction summary reports on a
quarterly basis, for certain malfunctions, instead of individual, 30-
day malfunction reports.
    Therefore, under Sec.  803.19, FDA is granting the manufacturers of
devices within eligible product codes, as identified in FDA's Product
Classification Database (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm) on August 17, 2018, an alternative to
the reporting requirements at Sec. Sec.  803.10(c)(1),
803.20(b)(3)(ii), 803.50(a)(2), 803.52, and 803.56 with respect to
reportable malfunction events associated with those devices. The list
reflects FDA's consideration of a list proposed by industry
representatives, consistent with the MDUFA IV Commitment Letter, as
well as the comments received on the 2017 Proposal regarding eligible
product codes. To assist manufacturers and the public in identifying
which product codes are eligible for participation in this voluntary
program, FDA's searchable Product Classification Database (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm)
has been updated to reflect such eligibility. As discussed in section
II, FDA is also making some changes to the conditions of the
alternative after considering the comments received on the 2017
Proposal.
    The alternative permits manufacturers of devices within eligible
product codes to submit malfunction reports in summary format on a
quarterly basis for those devices, subject to the conditions of the
alternative described in the remainder of this section. Such
manufacturers ``self-elect'' to participate by submitting summary
malfunction reports in accordance with the conditions of the
alternative. They do not need to submit a separate application to FDA
to participate.\1\
---------------------------------------------------------------------------

    \1\ We note that the Voluntary Malfunction Summary Reporting
Program does not apply to importers or device user facilities.
Therefore, requirements under part 803 for importers and device user
facilities are unaffected by this alternative. For example,
importers will continue to submit individual MDRs to the
manufacturer under Sec.  803.40.
---------------------------------------------------------------------------

    The remainder of this section describes the following conditions
that manufacturers must follow if they choose to submit summary
malfunction reports for devices within eligible product codes under the
alternative: (1) The conditions under which individual malfunction
reports are required; (2) submission of supplemental reports; (3) the
format for summary malfunction reports; (4) considerations for
combination products; and (5) the schedule and other logistics for
submission of summary reports. Because this is an alternative, if a
manufacturer does not submit summary reports for reportable malfunction
events in accordance with the conditions described in this section,
including the reporting schedule and format, then the manufacturer must
submit individual malfunction reports in compliance with all
requirements under part 803 (unless the manufacturer has been granted a
different exemption, variance, or alternative that applies).

A. Events Outside the Scope of This Alternative

    The Voluntary Malfunction Summary Reporting Program does not apply
to reportable death or serious injury events, which are still required
to be reported to FDA within the mandatory 30-calendar-day timeframe,
under Sec. Sec.  [thinsp]803.50 and 803.52, or within the 5-work day
timeframe under Sec.  [thinsp]803.53. Thus, if a manufacturer
participating in the program becomes aware of information reasonably
suggesting that a device that it markets may have caused or contributed
to a death or serious injury, then the manufacturer must submit an
individual MDR for that event because it involves a reportable death or
serious injury.
    The reporting requirements at Sec.  803.53 also continue to apply
to manufacturers participating in the program. Under Sec.  803.53(a), a
5-day report must be filed if a manufacturer becomes aware of an MDR
reportable event that necessitates remedial action to prevent an
unreasonable risk of substantial harm to the public health. Further,
under Sec.  803.53(b), if FDA has made a written request for the
submission of a 5-day report, the manufacturer must submit, without
further requests, a 5-day report for all subsequent reportable
malfunctions of the same nature that involve substantially similar
devices for the time period specified in the written request. FDA may
extend the time period stated in the original written request if the
Agency determines it is in the interest of the public health (see Sec.
803.53(b)).

B. Individual Reporting Conditions

    Manufacturers of devices in eligible product codes may continue
submitting individual, 30-day malfunction reports in compliance with
Sec. Sec.  803.50 and 803.52 if they choose to do so. However, those
manufacturers may submit all reportable malfunction events for devices
in eligible product codes in the summary format and according to the
schedule described below in section IV.D and F, unless one of the
following individual reporting conditions applies:
1. A Reportable Malfunction Is Associated With a 5-Day Report
    After submitting a 5-day report required under Sec.  803.53(a), all
subsequent reportable malfunctions of the same nature that involve
substantially similar devices must be submitted as individual MDRs in

compliance with Sec. Sec.  803.50 and 803.52 until the date that the
remedial action has been terminated to FDA's satisfaction. Summary
reporting of malfunctions may then resume on the regularly scheduled
summary reporting cycle. Submission of reportable malfunctions
associated with 5-day reports in this manner will assist FDA in
monitoring the time course and resolution of the issue presenting an
unreasonable risk of substantial harm to the public health.
2. A Reportable Malfunction Is the Subject of Certain Device Recalls
    When a device is the subject of a recall involving the correction
or removal of the device to address a malfunction and that correction
or removal is required to be reported to FDA under part 806,\2\ all
reportable malfunction events of the same nature that involve the same
device or a similar device marketed by the manufacturer must be
submitted as individual MDRs in accordance with Sec. Sec.  803.50 and
803.52 until the date that the recall is terminated. After the recall
is terminated, summary reporting may resume on the regularly scheduled
summary reporting cycle. The requirement to submit individual reports
under this condition is triggered on the date that the manufacturer
submits a report of a correction or removal required under part 806 (or
the date that the manufacturer submits a report of the correction or
removal under part 803 or part 1004 instead, as permitted under Sec.
806.10(f)). This will allow FDA to monitor the frequency of reportable
malfunctions associated with the recall and effectiveness of the recall
strategy.
---------------------------------------------------------------------------

    \2\ FDA regulations provide that ``[e]ach device manufacturer or
importer shall submit a written report to FDA of any correction or
removal of a device initiated by such manufacturer or importer if
the correction or removal was initiated: (1) To reduce a risk to
health posed by the device or (2) to remedy a violation of the act
caused by the device which may present a risk to health unless the
information has already been provided as set forth in paragraph (f)
of this section or the corrective or removal action is exempt from
the reporting requirements under Sec.  806.1(b).'' We note that
under part 806, manufacturers and importers are not required to
report a correction or removal that meets the definition of a class
III recall under 21 CFR part 7. (See 21 CFR 7.3(g) and (m), 806.2(d)
and (j) through (k), and 806.10; see also 62 FR 27183 at 27184.)
---------------------------------------------------------------------------

    If a manufacturer becomes aware of reportable malfunction events
before the date that the requirement to submit individual reports is
triggered and a summary report for those events has not yet been
submitted to FDA, then the manufacturer must submit any of those
malfunction events related to the recall in a summary MDR format within
30 calendar days of submitting the required report of correction or
removal. In the summary MDR, the manufacturer must include a check box
of recall in section H.7 of the electronic Form FDA 3500A.
3. FDA Has Determined That Individual MDR Reporting Is Necessary To
Address a Public Health Issue
    If FDA has determined that individual malfunction reports are
necessary to provide additional information and more rapid reporting
for an identified public health issue involving certain devices,
manufacturers must submit reportable malfunction events for those
devices as individual MDRs in compliance with Sec. Sec.  803.50 and
803.52. Under these circumstances, FDA will provide written
notification to manufacturers of relevant devices that individual MDR
submissions are necessary. FDA will provide further written notice when
manufacturers of those devices may resume participation in summary
malfunction reporting.
    The requirement to submit individual reports under this condition
is triggered on the date the manufacturer receives the written
notification from FDA. If a manufacturer became aware of reportable
malfunction events before the date that the requirement to submit
individual reports is triggered and a summary report for those events
has not yet been submitted to FDA, then the manufacturer must submit
any of those malfunction events for the identified devices to FDA
within 30 calendar days of receiving notification from FDA.
4. FDA Has Determined That a Device Manufacturer May Not Report in
Summary Reporting Format
    FDA may determine that a specific manufacturer is no longer allowed
to participate in the Voluntary Malfunction Summary Reporting Program
for reasons including, but not limited to, failure to comply with
applicable MDR requirements under part 803, failure to follow the
conditions of the program, or the need to monitor a public health
issue. In that case, FDA will provide written notification to the
device manufacturer to submit individual malfunction reports in
compliance with Sec. Sec.  803.50 and 803.52. The requirement to submit
individual reports under this condition is triggered on the date the
manufacturer receives the written notification from FDA. If a
manufacturer became aware of reportable malfunction events before the
date that the requirement to submit individual reports is triggered
under this condition and a summary report for those events has not yet
been submitted to FDA, then the manufacturer must submit those
malfunction events within 30 calendar days of receiving notification
from FDA.
5. A New Type of Reportable Malfunction Occurs for a Device
    If a manufacturer becomes aware of information reasonably
suggesting a reportable malfunction event has occurred for a device
that the manufacturer markets and the reportable malfunction is a new
type of malfunction that the manufacturer has not previously reported
to FDA for that device, then the manufacturer must submit an individual
report for that reportable malfunction in compliance with Sec. Sec.
803.50 and 803.52. After the manufacturer submits this initial
individual report, subsequent malfunctions of this type may be
submitted in summary form according to the reporting schedule in table
1, unless another individual reporting condition applies.

C. Supplemental Reports

    In general, if a manufacturer obtains information required in a
malfunction summary report (see section IV.D. describing the required
content of a summary report), that the manufacturer did not provide
because it was not known or was not available when the manufacturer
submitted the initial summary malfunction report, the manufacturer must
submit the supplemental information to FDA in an electronic format in
accordance with Sec.  803.12(a). The supplemental information must be
submitted to FDA by the submission deadline described in the Summary
Malfunction Reporting Schedule (table 1), according to the date on
which the manufacturer becomes aware of the supplemental information.
Manufacturers must continue to follow the requirements for the content
of supplemental reports set forth at Sec.  803.56(a) thorough (c),
meaning that on a supplemental or follow up report, the manufacturer
must: (a) Indicate that the report being submitted is a supplemental or
follow up report; (b) submit the appropriate identification numbers of
the report that you are updating with the supplemental information
(e.g., your original manufacturer report number and the user facility
or importer report number of any report on which your report was
based), if applicable; and (c) include only the new, changed, or
corrected information.
    However, if a manufacturer submits a summary malfunction report and
subsequently becomes aware of information reasonably suggesting that

an event (or events) summarized therein represents a reportable serious
injury or death event, or a new type of reportable malfunction, then
the manufacturer must submit reports as follows: The manufacturer must
submit an initial, individual MDR for the identified serious injury,
death, or new type of reportable malfunction event within 30 calendar
days of becoming aware of the additional information. The manufacturer
must simultaneously submit a supplement to the initial malfunction
summary report reducing the number of events summarized accordingly, so
that the total number of events remains the same.

D. Malfunction Reporting Summary Format

    Manufacturers of devices in eligible product codes who elect to
participate in the Voluntary Malfunction Summary Reporting Program must
submit summary malfunction reports in the format described below. As
detailed in the 2017 Proposal and Appendix, the format largely adopts
the format that was tested in FDA's Pilot Program for Medical Device
Reporting on Malfunctions and is compatible with the Form FDA 3500A
(Ref. 9), which allows manufacturers to submit MDRs using the same
electronic submission form that they use to submit individual MDRs, in
accordance with the eMDR Final Rule (79 FR 8832, February 14, 2014).
Because summary malfunction reports represent a grouping of malfunction
events for a specific model of a device, the summary reporting format
would require an additional element in the summary text narrative to
identify the number of reportable malfunctions that each report
represents. As described below, the XML tags ``'' and ``''
are placed on both sides of the number of events (NOE) to make the
number extractable from the report. FDA believes that submission of
summary reports in the format described below will provide the most
compact and efficient reporting mechanism for streamlining malfunction
reporting that still provides sufficient detail for FDA to monitor
devices effectively.
    Format Instructions: Separate summary malfunction reports must be
submitted for each unique combination of brand name, device model, and
problem code(s). (See Appendix A for case examples of how to report
(Ref. 6).) Each summary malfunction report must include at least the
following information collected on Form FDA 3500A and must be submitted
in an electronic format:
     SECTION B.5: Describe Event or Problem--To distinguish
this report as a summary malfunction report, the first sentence of the
device event narrative must read: ``This report summarizes  XXX  malfunction events,'' where XXX is replaced by the number of
malfunction events being summarized.
    The device event narrative must then include a detailed description
of the nature of the events and, if relevant and available, we
recommend including a range of patient age and weight and a breakdown
of patient gender, race, and ethnicity.
     SECTION D.1: Brand Name.
     SECTION D.2 and D.2.b: Common Device Name and Product
Code. Include the common name of the device and Product Classification
Code (Procode).
     SECTION D.3: Manufacturer Name, City, and State.
     SECTION D.4: Device Identification--Enter the model and/or
catalog number and lot number(s) and/or serial number(s) for the
devices that are the subject of the MDR. Include any device identifier
(DI) portion of the unique device identifier (UDI) for the device
version or model that is the subject of the MDR.
     SECTION G.1: Contact Office (and Manufacturing Site(s) for
Devices)--Enter the name, address, and email of the manufacturer
reporting site (contact office), including the contact name for the
summary report being submitted. Enter the name and address of the
manufacturing site(s) for the device, if different from the contact
office.
     SECTION G.2: Phone Number of Contact Office.
     SECTION G.5: Combination Products--If applicable, indicate
that the report involves a combination product (see section IV.E.).
     SECTION H.1: Type of Reportable Event--Check
``Malfunction'' in this box.
     SECTION H.6: Event Problem and Evaluation Codes--
    [cir] Enter the device problem code(s). (See Appendix A for case
examples of how to report (Ref. 6).)
    [cir] Enter the evaluation code(s) for the following categories:
Method, Results, Conclusion.
    [cir] Enter a Conclusion Code, even if the device was not
evaluated.
     SECTION H.10: Additional Manufacturer Narrative--Provide a
summary of the results of the investigation for the reported
malfunctions, including any follow up actions taken, and any additional
information that would be helpful in understanding how the manufacturer
addressed the malfunction events summarized in the report. Enter a
breakdown of the malfunction events summarized in the report, including
the number of devices that were returned, the number of devices that
were labeled ``for single use'' (if any), and the number of devices
that were reprocessed and reused (if any).

E. Combination Product Considerations

    As noted in the response to comment 17 above, device-led
combination products are included in this alternative that we are
granting under Sec.  803.19 to permit voluntary malfunction summary
reporting. The eMDR data system and instructions support use of the
Voluntary Malfunction Summary Reporting Program for device-led
combination products. However, as discussed in response to comment 17
above, additional considerations need to be addressed before drug and
biologic-led combination products could be included in the Voluntary
Malfunction Summary Reporting Program. As noted in Response 17, the
Agency intends to delay enforcement of the malfunction reporting
requirements for drug and biologic-led combination products under the
PMSR final rule. FDA will consider the relevant comments received on
the 2017 Proposal, as well as any additional, relevant comments
relating to malfunction reporting for drug and biologic-led combination
products submitted in relation to the PMSR draft guidance in developing
an approach for voluntary malfunction summary reporting for such
combination products.

F. Submission Schedule and Logistics

    Manufacturers submitting malfunction summary reports or
supplemental reports to a malfunction summary report must use
electronic reporting (Ref. 10) to submit those reports on a quarterly
basis according to the schedule in table 1. The summary malfunction
report must include the MDR Number, which consists of the registration
number of the manufacturer, the year in which the event is being
reported, and a 5-digit sequence number. Information included in a
malfunction summary report must be current as of the last date of the
quarterly timeframe identified in the first column of table 1.

             Table 1--Summary Malfunction Reporting Schedule
------------------------------------------------------------------------
    Reportable malfunctions or
supplemental information that you
   become aware of during these         Must be submitted to FDA by:
           timeframes:
------------------------------------------------------------------------
January 1-March 31...............  April 30.
April 1-June 30..................  July 31.
July 1-September 30..............  October 31.
October 1-December 31............  January 31.
------------------------------------------------------------------------

    The Voluntary Malfunction Summary Reporting Program applies only to
reportable malfunction events that manufacturers become aware of on or
after August 17, 2018. The deadline for FDA accepting the first round
of quarterly reports for this program is October 31, 2018.
    Under Sec. Sec.  803.17 and 803.18, manufacturers are required to
develop, maintain, and implement written MDR procedures and establish
and maintain MDR event files, and those requirements remain applicable
for manufacturers that elect to participate in this program. Among
other things, a manufacturer must develop, maintain, and implement MDR
procedures that provide for timely transmission of complete MDRs to
FDA. (See Sec.  803.17(a)(3)). Manufacturers participating in the
Voluntary Malfunction Summary Reporting Program will need to update
their internal MDR processes and procedures to provide for submitting
summary malfunction reports within the Summary Malfunction Reporting
Schedule.

V. Implementation Strategy

    The goal of the Voluntary Malfunction Summary Reporting Program is
to permit manufacturers of devices under certain product codes to
report malfunctions on a quarterly basis and in a summary format, as
outlined in the MDUFA IV Commitment Letter (Ref. 1), in a manner that
provides for effective monitoring of devices and is beneficial for FDA,
industry, and the public. An important part of this voluntary program
is providing clarification to manufacturers regarding the product codes
eligible for the program.
    Consistent with the MDUFA IV Commitment Letter (Ref. 1), FDA has
identified eligible product codes for the Voluntary Malfunction Summary
Reporting Program in FDA's Product Classification Database, available
on FDA's website, as part of granting the alternative (see https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm).
Manufacturers that choose to participate in quarterly, summary
reporting through this program will remain responsible for complying
with applicable MDR requirements under part 803 (e.g., requirements to
establish and maintain MDR event files under Sec.  803.18) and QS
requirements under part 820 (21 CFR part 820) (e.g., the requirement to
evaluate, review, and investigate any complaint that represents an MDR
reportable event under Sec.  820.198).
    If FDA determines that individual malfunction reports are necessary
from a specific manufacturer or for specific devices, FDA will notify
relevant manufacturers that they must submit individual reports and
provide an explanation for that decision and, as appropriate, the steps
necessary to return to summary, quarterly reporting. The Agency also
notes that, under Sec.  803.19(d), it may revoke or modify in writing
an exemption, variance, or alternative reporting requirement if it
determines that revocation or modification is necessary to protect the
public health.

VI. Updating Product Codes for Inclusion Into the Program

    FDA recognizes that new product codes will be created after the
date of granting the Voluntary Malfunction Summary Reporting Program
alternative under Sec.  803.19. In general, FDA does not intend to
consider devices under product codes in existence for less than 2 years
to be eligible for the program, unless the new product code was issued
solely for administrative reasons. Any product code in existence after
the publication date will be initially ineligible to participate in the
program. However, FDA will periodically evaluate new product codes
after they have been in existence for 2 years to determine whether they
should be added to the list of product codes eligible for the Voluntary
Malfunction Summary Reporting Program. If FDA determines that a new
product code should be added, then it will grant manufacturers of
devices within that product code the same alternative under Sec.
803.19 for malfunction events associated with those devices and update
FDA's Product Classification database accordingly to reflect the
changes.
    Manufacturers can send a request for a product code to be added to
the list of eligible product codes and for manufacturers of devices
within that product code to be granted the same alternative for
malfunction events associated with those devices to the
[email protected] mailbox. You may also mail your written request
to MDR Policy Branch, Division of Postmarket Surveillance, Office of
Surveillance and Biometrics, Center for Devices and Radiological
Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 3217, Silver Spring, MD
20993-0002.

VII. Conclusion

    In accordance with section 519(a)(1)(B)(i) of the FD&C Act and
Sec.  803.19, FDA is granting the alternative described in section IV
to manufacturers of devices in eligible product codes, as identified in
the FDA Product Classification Database (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm) on
August 17, 2018. FDA believes that for the devices in eligible product
codes, quarterly, summary reporting in accordance with the conditions
of the alternative will be as effective as the current MDR regulatory
requirements for purposes of identifying and monitoring potential
device safety concerns and device malfunctions. The Voluntary
Malfunction Summary Reporting Program will allow manufacturers to
submit summary reports with event narratives that will help FDA more
efficiently process malfunction reports and identify malfunction
trends. In addition, FDA's determination of product code eligibility
and the conditions of participation in the program will require
submission of individual 30-day or 5-day malfunction reports in
circumstances where such reports are necessary to protect public
health.

VIII. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.30(h) 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

    The Voluntary Malfunction Summary Reporting Program described in
this Notice contains information collection provisions 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). These provisions
have been approved under OMB control number 0910-0437.
    This document also refers to previously approved collections of
information. These collections of information are subject to review by
the OMB under the PRA (44 U.S.C. 3501-3520). The collections of
information in part 4, subpart B, regarding postmarketing safety
reporting for combination products have been approved under OMB control
number 0910-0834; the collections of information in part 803, regarding
medical device reporting, have been approved under OMB control number
0910-0437; the collections of information in 806, regarding corrections
and removals, have been approved under OMB control number 0910-0359;
the collections of information in 21 CFR part 807, subpart E, regarding
premarket notification, have been approved under OMB control number
0910-0120; the collections of information in 21 CFR part 814, subparts
A through E, regarding premarket approval, have been approved under OMB
control number 0910-0231; the collections of information in 21 CFR part
810, regarding medical device recall authority, have been approved
under OMB control number 0910-0432; the collections of information in
part 820, regarding quality system regulations, have been approved
under OMB control number 0910-0073; the collections of information in
21 CFR parts 1002 through 1050, regarding radiological health, have
been approved under OMB control number 0910-0025; the collections of
information regarding the MedWatch: The Food and Drug Administration
Medical Products Reporting Program have been approved under OMB control
number 0910-0291; and the collections of information regarding the
Adverse Event Program for Medical Devices (Medical Product Safety
Network (MedSun)) have been approved under OMB control number 0910-
0471.

X. References

    The following references are on display in the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 and are
available for viewing by interested persons between 9 a.m. and 4 p.m.,
Monday through Friday; they are also available electronically at
https://www.regulations.gov. 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. Medical Device User Fee Agreement IV Commitment Letter, available
at https://www.fda.gov/downloads/ForIndustry/UserFees/MedicalDeviceUserFee/UCM535548.pdf.
2. Food and Drug Administration, ``Medical Device Reporting--
Alternative Summary Reporting (ASR) Program; Guidance for
Industry,'' (October 19, 2000); available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072102.pdf.
3. Food and Drug Administration, ``Medical Device Reporting for
Manufacturers; Guidance for Industry and Food and Drug
Administration Staff,'' (November 8, 2016); available at https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm359566.pdf.
4. Food and Drug Administration, ``Center for Devices and
Radiological Health Appeals Processes; Guidance for Industry and
Food and Drug Administration Staff,'' (May 17, 2013); available at
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM284670.pdf.
5. Food and Drug Administration, ``International Medical Device
Regulators Forum,'' available at https://www.fda.gov/MedicalDevices/InternationalPrograms/IMDRF/default.htm.
6. Appendix A, ``Case Examples of Summary Malfunction Reporting,''
available in Docket No. FDA-2017-N-6730.
7. Food and Drug Administration, ``Postmarketing Safety Reporting
for Combination Products; Draft Guidance for Industry and Food and
Drug Administration Staff,'' (March 2018); available at https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM601454.pdf.
8. Food and Drug Administration, ``Compliance Policy for Combination
Product Postmarketing Safety Reporting, Immediately in Effect
Guidance for Industry and Food and Drug Administration Staff,''
available at https://www.fda.gov/RegulatoryInformation/Guidances/ucm601456.htm.
9. Food and Drug Administration, Form FDA 3500A, available at
https://www.fda.gov/downloads/aboutfda/reportsmanualsforms/forms/ucm048334.pdf. 5.
10. Electronic Medical Device Reporting (eMDR) (manufacturers may
obtain information on how to prepare and submit reports in an
electronic format that FDA can process, review, and archive),
available at: https://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm.

    Dated: August 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17770 Filed 8-16-18; 8:45 am]
 BILLING CODE 4164-01-P


Enclosure 2:  Instructions

Information Collection Request for the National Emission Standards for
Hazardous Air Pollutants for Secondary Aluminum Production

This information request is being conducted by the Environmental
Protection Agency's (EPA) Office of Air and Radiation (OAR) to assist
the EPA Administrator in developing emission standards for secondary
aluminum production under Clean Air Act (CAA) section 112.  The survey
is being sent under authority of Section 114 of the CAA.

Background:

 EPA proposed National Emission Standards for Hazardous Air Pollutants
(NESHAP) for secondary aluminum manufacturing on February 11, 1999 (64
FR 6946) and promulgated final regulations on March 23, 2000 (65 FR
15690).  Amendments to the rule were promulgated on September 24, 2002
(67 FR 59787),  December 30, 2002  (67 FR 79808),   September 3, 2004
(69 FR 53980,  October 3, 2005 (70 FR 57513),  and December 19, 2005 (70
FR 75320).

Directions:

All recipients must complete and return this survey by XXXX XX, 20XX.
Please complete the electronic version of the survey for your  facility.
  If your facility is not subject to 40 CFR 63, subpart RRR, please fill
in your name and address, indicate this on the survey and return it by
XXXX XX, 20XX.  The survey consists of two files included on the
enclosed compact disk (Enclosure 7).  A hard copy of the first file
(secondary aluminum questionnaire) is included as Enclosure 1 for
reference purposes.   The second file on the compact disk, National Air
Toxics Assessment /National Emissions Inventory (NATA/NEI) reporting
spreadsheet is to be used to update or correct data in the NATA NEI
database for your facility.  Section 114 of the CAA does not allow
emission data to be claimed as confidential.  You must complete both of
the files on the compact disk electronically.

As discussed in the cover letter, if you believe that disclosure of any
specific information that you submit would reveal confidential business
information (CBI) or a trade secret, you should clearly identify such
specific information and submit it separately from the non-CBI response.
 Please do not label an entire response "confidential" if only certain
portions consist of CBI or trade secrets.  Enclosures 4 and 6 contain
more information about CBI.  Do not e-mail a file that contains CBI.

The electronic version of the survey contains separate tabs for area
sources and major sources of HAP.  The area source tab does not contain
the questions in Part C of Enclosure 1.  The major source tab does not
contain Part D of Enclosure 1.  Please pay close attention to the tab
titles in the Excel spreadsheets and complete the appropriate tabs.
Definitions that may be useful in completing the secondary aluminum
questionnaire are provided in Appendix A to Enclosure 1, and included in
a definitions tab.

Please review and provide updated information for the National Air
Toxics Assessment /National Emissions Inventory (NATA/NEI) database as
requested in the NEI reporting spreadsheet.  EPA requires accurate
information on hazardous air pollutant (HAP) emissions and other risk
model input data that we will be using to assess risks from the
secondary aluminum production source category, as required by section
112(f) of the Clean Air Act.  The source of this information is the 2005
National Air Toxics Assessment National Emissions Inventory (2005 NATA
NEI), updated with data collected by EPA’s Office of Air Quality
Planning and Standards.  For more information about the 2005 National
Emissions Inventory (NEI), please go to
http://www.epa.gov/ttn/chief/net/2005inventory.html.  If the NATA/NEI
database presently contains any information about your facility, these
data are entered in the NEI reporting spreadsheet, included on the
compact disk (Enclosure 7).  Please correct or update these data as
necessary and fill in any blank fields, if possible.  If your facility
is not presently listed in the NATA/NEI database, no data have been
entered in the NEI spreadsheet.  Please fill in all of the fields in the
spreadsheet as accurately as possible.  Note that the NEI reporting
spreadsheet contains drop-down tables that may be helpful in completing
it. You may include comments and qualifying information in the rows
below the data that you enter.  Codes and definitions for the requested
data are given in the "lookups" and “help” tabs of NATA NEI
spreadsheet.

Please direct any questions regarding how to complete the Enclosures to
Rochelle Boyd with EPA’s Office of Air Quality Planning and Standards
at<PHONE_NUMBER> (e-mail:  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>).