[Federal Register Volume 82, Number 246 (Tuesday, December 26, 2017)]
[Proposed Rules]
[Pages 60922-60929]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27650]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 803

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


Center for Devices and Radiological Health; Medical Devices and 
Combination Products; Voluntary Malfunction Summary Reporting Program 
for Manufacturers

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; request for comments.

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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, is announcing a proposed program for manufacturer 
reporting of certain device malfunction medical device reports (MDRs) 
in summary form--the Voluntary Malfunction Summary Reporting Program. 
This proposed 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 Act of 2017 (MDUFA IV Commitment 
Letter). These goals include permitting manufacturers of devices in 
certain product codes to report malfunctions on a quarterly basis and 
in a summary format. In addition, this proposed program reflects FDA's 
findings from a pilot program the Agency conducted to study summary 
reporting formats for malfunction MDRs.

DATES: Submit either electronic or written comments on this 
notification by February 26, 2018. Submit comments on information 
collection issues under the Paperwork Reduction Act of 1995 by February 
26, 2018. See section IV of this document, the ``Paperwork Reduction 
Act of 1995.''

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before February 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of February 26, 2018. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-N-6730 for ``Voluntary Malfunction Summary Reporting Program 
for Manufacturers.'' Received comments, those filed in a timely manner 
(see ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
     Docket: For access to the docket to read background 
documents or the electronic and written/paper comments received, go to 
https://www.regulations.gov and insert the docket number, found in 
brackets in the heading of this document, into the ``Search'' box and 
follow the prompts and/or go to the Dockets Management Staff, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Isaac Chang, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 3114, Silver Spring, MD 20993, 301-796-6670, 
[email protected]; or Stephen Ripley, Center

[[Page 60923]]

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 post-market 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.
    The regulations contained in part 803 (21 CFR part 803) and issued 
under section 519 of the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) (21 U.S.C. 360i) set forth medical device reporting requirements. 
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 (see 
Sec. Sec.  803.10(c)(1) and 803.50(a)(2) (21 CFR 803.10(c)(1) and 
803.50(a)(2))). 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. 
(See Sec.  803.19(c).)
    FDA has historically granted exemptions, variances, and/or 
alternatives under Sec.  803.19 to allow a variety of summary reporting 
methods for select types of MDRs. For example, in October 2000, FDA 
issued guidance on the Alternative Summary Reporting (ASR) Program 
(Ref. 1). Through the ASR program, FDA has granted an exemption from 
individual reporting requirements of Sec. Sec.  803.50 and 803.52 to 
certain manufacturers, allowing them to efficiently submit reportable 
events in a compact manner. As a condition of exemptions, variances, or 
alternatives that FDA has granted in the past, device manufacturers 
were required to submit certain MDR reportable events to FDA in a 
``line item'' spreadsheet format consisting mainly of event codes (Ref. 
2). Although the summary reports contained this abridged data, as part 
of the request for an exemption, variance, or alternative, FDA also 
received a narrative description of the types of events that would be 
summarized in these reports.
    While FDA had sufficient understanding of the summary reports using 
the ``line item'' spreadsheet format, the Agency noted that the absence 
of a narrative in summary reports would make it more difficult for the 
public to interpret the coding in the summary reports and understand 
the context of the MDR using the publicly accessible MDR database. For 
example, a report with codes indicating corrosion and electrical issues 
may be difficult to interpret because this could be interpreted as: (1) 
Corrosion leading to an electrical issue, (2) an electrical issue 
leading to corrosion, or (3) an indeterminate relationship between the 
corrosion and electrical issue. However, with the inclusion of event 
narratives, this information is more easily understood. As a result, 
FDA believes it is important to include narratives in summary reporting 
to facilitate public understanding of the information and promote 
transparency in the publicly accessible MDR database.
    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--with the exception of 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 must 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 in order to protect 
the public health, pursuant to section 519(a)(1)(B)(i)(III) of the FD&C 
Act. Consequently, unless granted an individual exemption, variance, or 
alternative, manufacturers of those devices have continued to be 
required to submit individual malfunction reports under part 803, as 
was required pre-FDAAA.
    To facilitate exploration of an appropriate format for collecting 
malfunction reports in summary form, FDA announced in the Federal 
Register of August 18, 2015 (80 FR 50010), a ``Pilot Program for 
Medical Device Reporting on Malfunctions.'' In that document, FDA 
solicited volunteers for participation in the pilot program for the 
submission of MDRs in summary format on a quarterly basis for 
malfunctions of class I devices and those class II devices that are not 
permanently implantable, life supporting, or life sustaining. The 
announcement provided a comprehensive description of the pilot, the 
guiding principles, conditions, and examples of how to fill out the 
summary reports in different situations. The summary reporting format 
used in the pilot was an adaptation of the full electronic Form FDA 
3500A, which included event and manufacturer narratives (Ref. 3). In 
the pilot summary reporting format, one line was appended to Section B5 
(``event narrative'') that identified the number of events represented 
by the report. Reports were summarized for each model/catalog number of 
the device for each device problem type.
    The pilot demonstrated several important findings. First, 
participants were able to reduce the volume of reports by over 87 
percent using the pilot format, while preserving the essential 
information regarding the context around malfunction events. This 
increased efficiency in reporting and in the Agency review and 
processing of malfunction reports. The format also allowed for simple, 
transparent, and cost-effective reporting through existing electronic 
reporting processes for submission of electronic MDRs (eMDRs)

[[Page 60924]]

to FDA, in accordance with the Medical Device Reporting: Electronic 
Submissions Requirements Final Rule (eMDR Final Rule) published in the 
Federal Register of February 14, 2014 (79 FR 8832). Based upon 
observations from the pilot experience, this summary format was usable 
for both large and small firms with varying numbers of marketed 
devices. Lastly, summary reports collected in this format could be more 
easily shared publicly, facilitating transparency of malfunction 
reporting.
    Consistent with these findings, FDA believes that bundling ``like 
events'' together into a single summary report description would have 
benefits for manufacturers, FDA, and the public. For many 
manufacturers, this approach would greatly reduce the volume of reports 
that they would need to submit to FDA. For FDA, information would be 
received in a streamlined manner that would facilitate more efficient 
understanding of malfunction issues. For the public, summary reports 
could make malfunction event trends for a particular device more 
readily transparent. In the MDUFA IV Commitment Letter (Ref. 4), FDA 
and industry agreed to certain goals for streamlining malfunction 
reporting that would help achieve these benefits. These goals include 
permitting manufacturers of devices in certain product codes to report 
malfunctions on a quarterly basis and in a summary format. FDA also 
agreed to publish a list of device product codes for which 
manufacturers would be eligible to submit malfunction reports on a 
quarterly basis and in a summary MDR format. As explained in the MDUFA 
IV Commitment Letter, this list is to include product codes for class 
II implantable devices and class III devices, as appropriate, and 
reflect FDA's consideration of a list proposed by industry 
representatives.

II. Principles for Malfunction Summary Reporting

    Informed by the findings from the Pilot Program for Medical Device 
Reporting on Malfunctions, FDA has identified several overarching 
principles for summary reporting of malfunctions:
    1. The collection of information in summary format should allow FDA 
to collect sufficient detail to understand reportable malfunction 
events.
    2. To increase efficiency, summary malfunction reporting should 
occur in a common format for the electronic reporting system used.
    3. 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.
    4. Manufacturers should communicate information regarding an 
imminent hazard at the earliest time possible.
    5. 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 proposed Voluntary 
Malfunction Summary Reporting Program would remain subject to 
requirements for establishing and maintaining MDR event files under 
Sec.  803.18). In addition, under the Quality System (QS) Regulation, 
manufacturers must evaluate, review, and investigate any complaint that 
represents an MDR reportable event (see Sec.  820.198 (21 CFR 
820.198)).
    6. Summary reporting information should not be duplicative of 
information received through other MDR reporting processes.

III. Proposed Voluntary Malfunction Summary Reporting Program

    Based on the findings from the 2015 Pilot Program, the Agency's 
experience with summary reporting programs, and its experience with MDR 
reporting generally, FDA has determined it is appropriate to expand the 
opportunity to participate in summary malfunction reporting, consistent 
with the principles identified above. The Agency believes that for many 
types of reportable malfunctions, submission of summary reports on a 
quarterly basis would allow FDA to collect sufficient detail to monitor 
devices effectively. Currently, however, there are still situations in 
which submission of individual malfunction reports on a more prompt 
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 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. Thus, the Agency has determined that, at this time, all 
devices should remain subject to the reporting requirements at part 
803, to protect the public health.
    To expand the opportunity to participate in summary malfunction 
reporting, FDA is proposing that under Sec.  803.19, manufacturers of 
devices within eligible product codes would be granted an alternative 
to the reporting requirements at Sec. Sec.  803.10(c)(1), 
803.20(b)(3)(ii), 803.50(a)(2), and 803.52 with respect to reportable 
malfunction events associated with those devices. FDA is also 
considering how this proposed alternative may apply to combination 
products, and seeks comment on this issue (see 21 CFR 3.2(e) for 
definition of combination products and 21 CFR part 4, subpart B, for 
postmarketing safety reporting requirements for combination products). 
This proposed alternative would permit manufacturers to submit 
malfunction reports for devices within eligible product codes in 
summary format on a quarterly basis, subject to certain conditions. The 
proposed Voluntary Malfunction Summary Reporting Program would not 
apply to importers or device user facilities. Therefore, requirements 
under part 803 for importers and device user facilities would be 
unaffected. For example, importers will continue to submit individual 
MDRs to the manufacturer under Sec.  803.40.
    The remainder of this section describes the following aspects of 
the proposed program: (1) The conditions of participation in the 
program, (2) the format for summary malfunction reports, (3) the 
schedule and other logistics for submission of summary reports, (4) 
FDA's proposed implementation strategy for the program, and (5) adding 
to the list of product codes eligible for the program.

A. Program Conditions

    The proposed Voluntary Malfunction Summary Reporting Program would 
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 proposed program became aware of information 
reasonably suggesting that a device that it markets has malfunctioned, 
and that the malfunction may have caused or contributed to a death or 
serious injury, then the manufacturer would need to submit an 
individual MDR for that event because it involves a reportable death or 
serious injury.

[[Page 60925]]

    Manufacturers of devices in eligible product codes could continue 
submitting individual, 30-day malfunction reports in compliance with 
Sec. Sec.  803.50 and 803.52 if they choose to do so. However, under 
the proposed program, those manufacturers would be permitted to submit 
all reportable malfunction events for devices in eligible product codes 
in the summary format and according to the schedule described below in 
section III.B and C of the document, unless one of the following 
individual reporting conditions applies:
1. A Reportable Malfunction Is Associated With a 5-Day Report
    The reporting requirements at Sec.  803.53 would continue to apply 
to manufacturers participating in the proposed 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. 
Manufacturers participating in the proposed Voluntary Malfunction 
Summary Reporting Program must continue to submit reportable 
malfunction events that meet this standard as 5-day reports. In 
addition, after you submit a 5-day report, 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 90 days past the date that the 
remedial action has been resolved to FDA's satisfaction. Summary 
reporting of malfunctions may then resume on the regularly scheduled 
summary reporting cycle.
    If FDA has made a written request for the submission of a 5-day 
report, you 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)).
    Submission of reportable malfunctions associated with 5-day reports 
in this manner would allow FDA to monitor the time course and 
resolution of the issue presenting an unreasonable risk of substantial 
harm to the public health (see section II, summary reporting principle 
4).
2. A Reportable Malfunction Is the Subject of an Ongoing Device Recall
    When a device is the subject of a recall involving the correction 
or removal of a marketed product to address a malfunction, 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 to FDA until 90 days past the date the 
recall is terminated. Summary reporting may then resume on the 
regularly scheduled summary reporting cycle. This would allow FDA to 
monitor the frequency of reportable malfunctions associated with the 
recall and effectiveness of the recall strategy.
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 would provide written notice via 
letter to manufacturers of relevant devices that individual MDR 
submissions are necessary. FDA would provide further written notice 
when manufacturers of those devices may resume participation in summary 
malfunction reporting. If necessary to protect the public health, FDA 
may also revoke or modify in writing an exemption, variance, or 
alternative reporting requirement, pursuant to Sec.  803.19(d).
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 proposed 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 would provide written notification to the 
device manufacturer to submit individual malfunction reports in 
compliance with Sec. Sec.  803.50 and 803.52.
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.

B. Malfunction Reporting Summary Format

    Manufacturers of devices in eligible product codes who participate 
in this proposed voluntary program would submit summary malfunction 
reports in the format described below.
1. Format Rationale
    The proposed format for summary reporting largely adopts the format 
that was tested in the Pilot Program for Medical Device Reporting on 
Malfunctions.
    FDA considered several approaches to summarizing information, given 
the summary reporting principles identified in section II. Since 
contextual information is needed to sufficiently understand reported 
malfunctions, FDA considered formats in which narrative text fields 
would provide sufficient context (see section II, summary reporting 
principle 1). In addition, summary text narratives without patient-
specific information can often be shared publicly with fewer 
redactions, which may provide greater transparency of device-related 
malfunction information (see section II, summary reporting principle 
3).
    The QS regulation requires manufacturers to review, evaluate, and 
investigate any complaint that represents an event which must be 
reported to FDA under part 803, including reportable malfunction events 
(see Sec.  820.198). In situations where several malfunction complaints 
are similar, FDA has found that many manufacturers aggregate 
information at the device model and device problem level in their 
investigation process. While this does not reduce the investigation 
requirements for manufacturers under part 803 or part 820 (see section 
II, summary reporting principle 5), aggregating malfunction reports by 
product and device problem would significantly reduce the number of 
reports. Likewise, FDA generally evaluates malfunction information at 
the product and device problem level, which streamlines the processing 
of malfunction reports and accelerates FDA's understanding of device 
issues. Therefore, FDA has determined that it would be mutually 
beneficial to organize summary malfunction

[[Page 60926]]

reporting information according to product and device problem.
    A malfunction report may describe more than one device problem, and 
FDA believes that summary reporting information should not be 
duplicative (see section II, summary reporting principle 6). Therefore, 
FDA has developed a methodology to help ensure that summary malfunction 
reports are non-overlapping. Consider a hypothetical situation in which 
a manufacturer reports 100 malfunction events for a device, where 70 of 
those 100 reports represent device problem A, and 50 of those 100 
reports represent device problem B. Reporting device problems A and B 
separately would create confusion regarding the total number of events 
received. Thus, in this example, device problem A, device problem B, 
and the subsequent overlap A+B, would be reported as three separate 
MDRs: A report describing 50 occurrences of device problem A, a report 
describing 30 occurrences of device problem B, and a report describing 
20 occurrences involving both device problems A and B. In this way, the 
three separate MDRs would be mutually exclusive and unambiguous.
    In consideration of the least burdensome means of reporting, FDA 
has developed a format that is compatible with the Form FDA 3500A (Ref. 
3), 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). This would streamline the 
process of reporting (see section II, summary reporting principle 5). 
Because summary malfunction reports represent a grouping of malfunction 
events for a specific model of a device, the proposed 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 in section III.B.2., 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 would provide the most compact and efficient reporting 
mechanism for streamlining malfunction reporting that still provides 
sufficient detail for FDA to monitor devices effectively.
2. Format Instructions
    Separate summary malfunction reports would be submitted for each 
unique combination of device model and problem code(s). (See Appendix A 
for case examples of how to report (Ref. 5).) Each summary malfunction 
report would be required to include at least the following information 
collected on Form FDA 3500A and to 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, 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) 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(s) or model(s) that are 
the subject of the MDR.
     SECTION G.1: Contact Office (and Manufacturing Site 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 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 III.B.3).
     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. 5).)
    [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 your investigation for the reported 
malfunctions, including any followup actions taken, and any additional 
information that would be helpful in understanding how you 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 to you, the number of devices that were 
labeled ``for single use'' (if any), and the number of devices that 
were reprocessed and re-used (if any).
3. Combination Product Considerations
    As noted above, FDA is considering how the alternative that would 
be granted under Sec.  803.19 to permit summary malfunction reporting 
may apply to combination products that contain a device constituent 
part and seeks comment on this issue. FDA anticipates that 
modifications may be needed to the above format instructions for 
purposes of addressing combination product considerations. 
Additionally, if such combination products that received marketing 
authorization under a biological product or drug marketing application 
are included in the proposed alternative that would permit summary 
malfunction reporting, FDA anticipates that such reporting would be 
made through the Center for Drug Evaluation and Research's or CBER's 
electronic reporting system with adjustments made to the above format 
instructions for purposes of reporting through these systems. FDA seeks 
comment on these issues.

C. Submission Schedule and Logistics

    Under the proposed program, manufacturers submitting summary 
malfunction reports would be required to use electronic reporting (Ref. 
6) to submit those reports on a quarterly basis according to the 
schedule in table 1.

[[Page 60927]]



             Table 1--Summary Malfunction Reporting Schedule
------------------------------------------------------------------------
Reportable malfunctions that you become
   aware of during these timeframes:       Must be submitted to FDA by:
 
------------------------------------------------------------------------
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 summary malfunction report would be required to 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.
    With respect to combination products that include a device 
constituent part and that received marketing authorization under a 
biological product or drug marketing application, FDA seeks comment on 
whether a different reporting schedule would be more appropriate.

D. 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 summary format, as 
outlined in the MDUFA IV Commitment Letter (Ref. 4), in a manner that 
provides for effective monitoring of devices and is beneficial for FDA, 
industry, and the public. An important part of this proposed voluntary 
program is providing clarification to manufacturers regarding the 
product codes eligible for the program. FDA is currently in the process 
of evaluating device product codes to determine which ones should be 
eligible. The Agency is requesting comments on the product codes that 
should be eligible for this proposed Voluntary Malfunction Summary 
Reporting Program, including for combination products. FDA will 
consider the proposed list of eligible product codes submitted by 
industry along with any comments received on this proposal in 
determining the product codes that would be included in the proposed 
alternative granted to permit summary malfunction reporting.
    Consistent with the MDUFA IV Commitment Letter (Ref. 4), when this 
proposed voluntary program is finalized through publication of a 
Federal Register document granting the alternative under Sec.  803.19, 
FDA will identify on its website a list of device product codes that 
are eligible for the Voluntary Malfunction Summary Reporting Program as 
part of granting the alternative. Manufacturers that choose to 
participate in quarterly summary reporting through the proposed program 
would remain responsible for complying with applicable MDR requirements 
under part 803 (such as requirements to establish and maintain MDR 
event files under Sec.  803.18) and QS requirements under part 820 
(such as 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 would notify 
relevant manufacturers that they must submit individual reports and 
provide an explanation for that decision and 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.

E. Addition of Product Codes to the Program

    FDA recognizes that new product codes will be created after the 
date that the Agency would grant the proposed alternative under Sec.  
803.19 to initiate the Voluntary Malfunction Summary Reporting Program. 
In general, FDA does not intend to consider devices under product codes 
in existence for less than 2 years to be eligible for the proposed 
program, unless the new product code was issued solely for 
administrative reasons. However, FDA proposes to 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 is eligible, then it 
would grant manufacturers of devices within that product code the same 
proposed alternative under Sec.  803.19 for malfunction events 
associated with those devices. Manufacturers could also submit a 
request under Sec.  803.19(b) 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 proposed alternative for 
malfunction events associated with those devices.
    FDA believes that for many devices, the proposed quarterly summary 
reporting described above would be as effective as the current MDR 
reporting program for purposes of identifying and monitoring potential 
device safety concerns and device malfunctions. The proposed Voluntary 
Malfunction Summary Reporting Program would allow manufacturers to 
submit summary reports with event narratives that would help FDA more 
efficiently process malfunction reports and identify malfunction 
trends. In addition, FDA's determination of product code eligibility 
and the proposed conditions of participation in the program would 
require submission of individual 30-day or 5-day malfunction reports in 
circumstances where such reports are necessary to protect public 
health.

IV. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3520), Federal Agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct or sponsor. ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 
60-day notice in the Federal Register concerning each proposed 
collection of information, including each proposed revision of an 
existing collection of information, before submitting the collection to 
OMB for approval. To comply with this requirement, FDA is publishing 
notice of the proposed collection of information set forth in this 
document.
    FDA invites comments on the following topics: (1) Whether the 
proposed collection of information is necessary for the proper 
performance of FDA's functions, including whether the information will 
have practical utility; (2) the accuracy of FDA's estimate of the

[[Page 60928]]

burden of the proposed collection of information, including the 
validity of the methodology and assumptions used; (3) ways to enhance 
the quality, utility, and clarity of the information to be collected; 
and (4) ways to minimize the burden of the collection of information on 
respondents, including through the use of automated collection 
techniques, when appropriate, and other forms of information 
technology.

Medical Device Reporting: Electronic Submission Requirements--21 CFR 
part 803

OMB Control Number 0910-0437--Revision

    The information collection associated with part 803 is approved 
under OMB control number 0910-0437. We request revision of the 
information collection approval as described in this document.
    FDA is announcing this proposed program for manufacturer reporting 
of certain device malfunction MDRs in summary form--the Voluntary 
Malfunction Summary Reporting Program. The proposed program would 
permit manufacturers of devices in certain product codes to report 
malfunctions for those devices on a quarterly basis and in a summary 
format (instead of reporting them as individual, 30-day reports), 
subject to certain conditions. Therefore, we have added a line item to 
the reporting burden table for the proposed Voluntary Malfunction 
Summary Reporting Program.
    FDA believes that submission of voluntary summary reports in the 
format described in this document would provide the most compact and 
efficient reporting mechanism for streamlining malfunction reporting 
that still provides sufficient detail for FDA to monitor devices 
effectively. The proposed Voluntary Malfunction Summary Reporting 
Program is meant to streamline the process of reporting malfunctions. 
It does not change regulatory requirements for MDR-related 
investigations or recordkeeping by manufacturers. The proposed program 
would neither apply to importers or device user facilities, nor affect 
requirements under part 803 for importers or device user facilities. 
The proposed program would not apply to reportable death or serious 
injury events, as described above in section III.A. In addition, the 
reporting requirements at Sec.  803.53, which require a 5-day report to 
be filed at the written request of FDA or 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, 
would continue to apply to manufacturers participating in the proposed 
program. The conditions of the proposed Voluntary Summary Malfunction 
Reporting Program would also require manufacturers to submit individual 
malfunction reports in certain circumstances (see section III.A.). 
These factors were considered in determining the revised burden 
estimates described below in table 2.
    For the convenience of the reader, we have included below only the 
PRA line-items for the estimated annual reporting burden table from OMB 
control number 0910-0437 that we anticipate would be affected by the 
Voluntary Malfunction Summary Reporting Program. We have not included 
the information collection line-items that we do not anticipate would 
be affected by the proposed program and which we do not intend to 
revise at this time.

----------------------------------------------------------------------------------------------------------------
                                                   Number of
     Activity/CFR  section         Number of     responses per   Total annual    Average  burden    Total hours
                                  respondents     respondent       responses      per  response
----------------------------------------------------------------------------------------------------------------
Manufacturer Reporting--Sec.             1,240          272.50         337,900  0.10 (6 minutes)          33,790
 Sec.   803.50 through 803.53.
Voluntary Malfunction Summary            1,240           54.47          67,546  0.10 (6 minutes)           6,755
 Reporting Program.
Supplemental Reports--Sec.               1,050          128.71         135,148  0.10 (6 minutes)          13,515
 803.56.
----------------------------------------------------------------------------------------------------------------
\1\ There is no change to the capital costs or operating and maintenance costs associated with this revision of
  the collection of information.

    We believe the availability of the summary reporting option for 
manufacturers of certain devices would cause a decrease in the number 
of individual manufacturer reports for malfunctions submitted under 
Sec. Sec.  803.50 and 803.52. We have, therefore, revised the estimated 
number of responses for Manufacturer Reporting--Sec. Sec.  803.50 
through 803.53 accordingly. As explained above in section III.D., the 
Agency does not yet have a final list of the product codes that would 
be eligible for the proposed Voluntary Malfunction Summary Reporting 
Program, and FDA does not anticipate that all device product codes 
would be included in the alternative granted to permit summary, 
quarterly malfunction reporting. However, based on the scope and 
conditions of the proposed program, the interest industry has expressed 
in summary malfunction reporting, and our experience with MDR 
reporting, FDA estimates that approximately 10 percent of malfunction 
reports would continue to be submitted as individual reports after 
implementation of the proposed program. Approximately 67 percent of the 
manufacturer reports received under Sec. Sec.  803.50 through 803.53 
are malfunction reports (577,316 of the 857,484 total annual responses 
received in 2016). We therefore estimate the revised Responses per 
Respondent for ``Manufacturer Reporting--Sec. Sec.  803.50 through 
803.53'' to be 272.50.
    We estimate that a summary malfunction report would take 
approximately the same amount of time to prepare as an individual 
malfunction report. As discussed in section I of this document, FDA's 
Pilot Program for Medical Device Reporting on Malfunctions showed an 87 
percent reduction in the volume of reporting for malfunction reports 
with use of malfunction summary reporting. Assuming 90 percent of 
malfunction reports are submitted in summary reports, we estimate that 
manufacturers would submit an average of 54.47 summary reports annually 
under this proposed program.
    Based on our experience with supplemental reporting, we estimate 
that, at most, the number of supplemental reports would be 
approximately one third of the total number of individual reports and 
summary reports submitted annually. We, therefore, estimate the revised 
Responses per Respondent for ``Supplemental Reports--Sec.  803.56'' to 
be 128.71.
    We will update these estimates as appropriate based on comments 
received on this proposed information collection and the list of 
eligible device product codes that FDA develops.
    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-

[[Page 60929]]

3520). The collections of information in 21 CFR 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 21 CFR part 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 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.

V. References

    The following references are on display in the Dockets Management 
Staff (see ADDRESSES) 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. Food and Drug Administration, ``Medical Device Reporting--
Alternative Summary Reporting (ASR) Program, Guidance for 
Industry,'' available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072102.pdf.
    2. Food and Drug Administration, Event Problem Codes, available 
at https://www.fda.gov/medicaldevices/deviceregulationandguidance/postmarketrequirements/reportingadverseevents/mdradverseeventcodes/default.htm.
    3. Food and Drug Administration, FDA Form 3500A, available at 
https://www.fda.gov/downloads/aboutfda/reportsmanualsforms/forms/ucm048334.pdf.
    4. MDUFA IV Commitment Letter, available at https://www.fda.gov/downloads/ForIndustry/UserFees/MedicalDeviceUserFee/UCM535548.pdf.
    5. Appendix A, ``Case Examples of Summary Malfunction 
Reporting,'' available in Docket No. FDA-2017-N-6730.
    6. 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: http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm.

    Dated: December 19, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27650 Filed 12-22-17; 8:45 am]
BILLING CODE 4164-01-P


