[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]
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