Document ID: FDA-2017-N-6730-0034
Agency: fda
Document Type: Rule
Title: Medical Devices and Device-Led Combination Products: Voluntary Malfunction Summary Reporting Program for Manufacturers
Posted Date: 2018-08-17T04:00Z

[Federal Register Volume 83, Number 160 (Friday, August 17, 2018)]
[Rules and Regulations]
[Pages 40973-40985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 240-402-8010; 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)

[[Page 40974]]

(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

[[Page 40975]]

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

[[Page 40976]]

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.

[[Page 40977]]

    (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

[[Page 40978]]

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

[[Page 40979]]

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

[[Page 40980]]

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

[[Page 40981]]

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

[[Page 40982]]

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

[[Page 40983]]

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.

[[Page 40984]]

             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.

[[Page 40985]]

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