Rule2024-19414
Medical Devices and Device-Led Combination Products; Voluntary Malfunction Summary Reporting for Manufacturers
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Published
August 29, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing a minor, technical modification to an alternative that permits manufacturer reporting of certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis. We refer to this alternative as the "Voluntary Malfunction Summary Reporting Program."
Full Text
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<title>Federal Register, Volume 89 Issue 168 (Thursday, August 29, 2024)</title>
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[Federal Register Volume 89, Number 168 (Thursday, August 29, 2024)]
[Rules and Regulations]
[Pages 70096-70100]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-19414]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 803
[Docket No. FDA-2017-N-6730]
Medical Devices and Device-Led Combination Products; Voluntary
Malfunction Summary Reporting for Manufacturers
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Notification; order granting modification to alternative.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing a minor, technical modification to an alternative that
permits manufacturer reporting of certain device malfunction medical
device reports (MDRs) in summary form on a quarterly basis. We refer to
this alternative as the ``Voluntary Malfunction Summary Reporting
Program.''
DATES: This modification applies to voluntary summary reports for
reportable malfunction events that manufacturers become aware of on or
after August 29, 2024.
FOR FURTHER INFORMATION CONTACT: Michelle Rios, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1116, Silver Spring, MD 20993-0002, 301-796-6107;
or James Myers, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
Every year, FDA receives over two million MDRs of suspected device-
associated deaths, serious injuries, and malfunctions. The Agency's MDR
program is one of the postmarket surveillance tools FDA uses to monitor
device performance, detect potential device-related safety issues, and
contribute to benefit-risk assessments. Malfunction reports represent
most of the MDRs FDA receives on an annual basis.
Medical device reporting requirements for manufacturers are set
forth in section 519 of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360i) and the regulations contained in part 803 (21 CFR
part 803). Among other things, part 803 requires the submission of an
individual MDR when a manufacturer becomes aware of information, from
any source, that reasonably suggests that one of its marketed devices
malfunctioned and the malfunction of the device or a similar device
marketed by the manufacturer would be likely to cause or contribute to
a death or serious injury if the malfunction were to recur (Sec. Sec.
803.10(c)(1) and 803.50(a)(2)). Throughout this document, we refer to
such malfunctions as ``reportable malfunctions'' or ``reportable
malfunction events.''
Under Sec. 803.19, FDA may grant exemptions or variances from, or
alternatives to, any or all of the reporting requirements in part 803,
and may change the frequency of reporting to quarterly, semiannually,
annually, or other appropriate time period. FDA may grant such
modifications upon request or at its discretion, and when granting such
modifications, FDA may impose other reporting requirements to ensure
the protection of the public health (see Sec. 803.19(c)).
In accordance with section 519(a)(1)(B)(i) of the FD&C Act and
Sec. 803.19, FDA granted to manufacturers of devices in eligible
product codes, as identified in the FDA Product Classification Database
(<a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm">https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm</a>) on August 17, 2018, an alternative that permits
submission of malfunction summary reports on a quarterly basis for
certain device malfunctions. The Agency published a document of the
alternative in the Federal Register (83 FR 40973, August 17, 2018).
Consistent with that document, FDA subsequently determined that
additional product codes are eligible for the Voluntary Malfunction
Summary Reporting Program (the program) and granted the same
alternative to manufacturers of devices in those product codes.
FDA believes that for the devices in eligible product codes,
quarterly, summary reporting in accordance with the conditions of the
alternative is as effective as the current MDR regulatory requirements
for purposes of identifying and monitoring potential device safety
concerns and device malfunctions. The program allows manufacturers to
submit summary reports with event narratives that help FDA more
efficiently process malfunction reports and identify malfunction
trends. In addition, FDA's determination of product code eligibility
and the conditions of participation in the program serve to require
submission of individual 30-day or 5-day malfunction reports in
circumstances where such reports are necessary to protect public
health.
II. Modification to Malfunction Summary Reporting Format for the
Voluntary Malfunction Summary Reporting Program
Under Sec. 803.19(d), FDA ``may revoke or modify in writing an
exemption, variance, or alternative reporting requirement if we
determine that revocation or modification is necessary to protect the
public health.''
To meet the conditions of the Voluntary Malfunction Summary
Reporting Program (VMSR), manufacturers of devices in eligible product
codes who elect to participate in the program must submit summary
malfunction reports electronically using Form FDA 3500A (Ref. 1)
pursuant to the malfunction reporting summary format described in the
document published in 2018 (83 FR 40973, August 17, 2018). However,
since the program began in 2018, FDA has revised Form FDA 3500A. For
example, FDA has added a ``check box'' and field in which the
manufacturer may specifically indicate that a report is a ``summary
report'' and enter the number of events being summarized. Additionally,
FDA has added a field that facilitates clearer identification of a
report as a VMSR summary reports. Use of these features of the revised
Form 3500A allows FDA to more efficiently identify VMSR summary reports
and the number of events summarized, enabling more effective review of
these reports. Certain fields in the Form FDA 3500A have also changed
so that they no longer align exactly with the instructions describing
the required malfunction reporting summary format for the program. In
addition, FDA's MDR references for adverse event codes have been
updated.
Revising the required format for summary malfunction reports
submitted under the VMSR Program to align with the most current Form
FDA 3500A and adverse event codes will avoid confusion and help ensure
the accuracy and consistency of information in summary malfunction
reports. Consistent, accurate summary reports are necessary to ensure
that both FDA
[[Page 70097]]
and the public are able to find information about device malfunctions
and identify malfunction trends more readily. Therefore, we have
determined that modifying the malfunction reporting summary format
under Sec. 803.19(d) to align with the revised Form FDA 3500A and
updated references for MDR adverse event codes is necessary to protect
the public health. Specifically, we are making the following changes:
<bullet> Use of dedicated fields to identify the report as a VMSR
summary malfunction report. Instead of using XML tags ``<NOE> XXX
<NOE>'' in the ``Describe Event or Problem'' section of Form FDA 3500A,
manufacturers must use the following fields:
[ssquf] In the ``Exemption/Variance Number'' field, include the
term ``VMSR.''
[ssquf] In the ``Type of Reportable Event'' section of the Form FDA
3500A, check the ``Summary Report'' box and identify the number of
events in the ``Number of Events Summarized'' field.
<bullet> Update the adverse events code references, from Method,
Results and Conclusions to ``Type of Investigation'', ``Investigation
Findings'', and ``Investigation Conclusions''.
<bullet> Remove references to the specific number identifiers for
the Form FDA 3500A sections from the description of the malfunction
summary reporting format and individual reporting conditions (as
applicable) to remove inconsistency with the current version of the
Form FDA 3500A. The sections are instead identified only by description
name.
III. Voluntary Malfunction Summary Reporting Program
FDA is republishing the conditions that manufacturers must follow
if they choose to participate in the Voluntary Malfunction Summary
Reporting Program with the changes described in section II of this
document incorporated, along with a few editorial changes for clarity.
Under Sec. 803.19, FDA has granted the manufacturers of devices within
eligible product codes, as identified in FDA's Product Classification
Database (<a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm">https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm</a>), an alternative to the reporting requirements at
Sec. Sec. 803.10(c)(1), 803.20(b)(3)(ii), 803.50(a)(2), 803.52, and
803.56 with respect to reportable malfunction events associated with
those devices. The alternative permits manufacturers of devices within
eligible product codes to submit malfunction reports in summary format
on a quarterly basis for those devices, subject to the conditions of
the alternative described in the remainder of this section. Such
manufacturers ``self-elect'' to participate by submitting summary
malfunction reports in accordance with the conditions of the
alternative. They do not need to submit a separate application to FDA
to participate.\1\ The remainder of this section describes the
following conditions that manufacturers must follow if they choose to
submit summary malfunction reports for devices within eligible product
codes under the alternative: (1) the conditions under which individual
malfunction reports are required; (2) submission of supplemental
reports; (3) the revised format for summary malfunction reports; (4)
considerations for combination products; and (5) the schedule and other
logistics for submission of summary reports. Because this is an
alternative, if a manufacturer does not submit summary reports for
reportable malfunction events in accordance with the conditions
described in this section, including the reporting schedule and format,
then the manufacturer must submit individual malfunction reports in
compliance with all requirements under part 803 (unless the
manufacturer has been granted a different exemption, variance, or
alternative that applies).
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\1\ We note that the Voluntary Malfunction Summary Reporting
Program does not apply to importers or device user facilities.
Therefore, requirements under 21 CFR part 803 for importers and
device user facilities are unaffected by this alternative. For
example, importers will continue to submit individual MDRs to the
manufacturer under Sec. 803.40.
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A. Events Outside the Scope of This Alternative
The Voluntary Malfunction Summary Reporting Program does not apply
to reportable death or serious injury events, which are still required
to be reported to FDA within the mandatory 30-calendar-day timeframe,
under Sec. Sec. 803.50 and 803.52, or within the 5-work day timeframe
under Sec. 803.53. Thus, if a manufacturer participating in the
program becomes aware of information reasonably suggesting that a
device that it markets may have caused or contributed to a death or
serious injury, then the manufacturer must submit an individual MDR for
that event because it involves a reportable death or serious injury.
The reporting requirements at Sec. 803.53 also continue to apply
to manufacturers participating in the program. Under Sec. 803.53(a), a
5-day report must be filed if a manufacturer becomes aware of an MDR
reportable event that necessitates remedial action to prevent an
unreasonable risk of substantial harm to the public health. Further,
under Sec. 803.53(b), if FDA has made a written request for the
submission of a 5-day report, the manufacturer must submit, without
further requests, a 5-day report for all subsequent reportable
malfunctions of the same nature that involve substantially similar
devices for the time period specified in the written request. FDA may
extend the time period stated in the original written request if the
Agency determines it is in the interest of the public health (see Sec.
803.53(b)).
B. Individual Reporting Conditions
Manufacturers of devices in eligible product codes may continue
submitting individual, 30-day malfunction reports in compliance with
Sec. Sec. 803.50 and 803.52 if they choose to do so. However, those
manufacturers may submit all reportable malfunction events for devices
in eligible product codes in the summary format and according to the
schedule described below in section III.D. and F, unless one of the
following individual reporting conditions applies:
1. A Reportable Malfunction Is Associated With a 5-Day Report
After submitting a 5-day report required under Sec. 803.53(a), all
subsequent reportable malfunctions of the same nature that involve
substantially similar devices must be submitted as individual MDRs in
compliance with Sec. Sec. 803.50 and 803.52 until the date that the
remedial action has been terminated to FDA's satisfaction. Summary
reporting of malfunctions may then resume on the regularly scheduled
summary reporting cycle. Submission of reportable malfunctions
associated with 5-day reports in this manner will assist FDA in
monitoring the time course and resolution of the issue presenting an
unreasonable risk of substantial harm to the public health.
2. A Reportable Malfunction Is the Subject of Certain Device Recalls
When a device is the subject of a recall involving the correction
or removal of the device to address a malfunction and that correction
or removal is required to be reported to FDA under part 806 (21 CFR
part 806), all reportable malfunction events of the same nature that
involve the same device or a similar device marketed by the
manufacturer must be submitted as individual MDRs in accordance with
Sec. Sec. 803.50 and 803.52 until the date that the recall is
terminated. As stated in 21 CFR 806.10(a), FDA regulations require
[[Page 70098]]
that manufacturers submit a written report to FDA of any correction or
removal of a device by the manufacturer if it was initiated to reduce a
risk to health posed by the device; or to remedy a violation of the Act
caused by the device which may present a risk to health unless the
information has already been provided or the corrective or removal
action is exempt from the reporting requirements under Sec. 806.1(b).
We note that under part 806, manufacturers and importers are not
required to report a correction or removal that meets the definition of
a class III recall under part 7 (21 CFR part 7). (See Sec. Sec. 7.3(g)
and (m), 806.2(d) and (j) through (k), and 806.10(a); see also 62 FR
27183 at 27184.) After the recall is terminated, summary reporting may
resume on the regularly scheduled summary reporting cycle. The
requirement to submit individual reports under this condition is
triggered on the date that the manufacturer submits a report of a
correction or removal required under part 806 (or the date that the
manufacturer submits a report of the correction or removal under part
803 or 21 CFR part 1004 instead, as permitted under Sec. 806.10(f)).
This will allow FDA to monitor the frequency of reportable malfunctions
associated with the recall and effectiveness of the recall strategy.
If a manufacturer becomes aware of reportable malfunction events
before the date that the requirement to submit individual reports is
triggered and a summary report for those events has not yet been
submitted to FDA, then the manufacturer must submit any of those
malfunction events related to the recall in a summary MDR format within
30-calendar days of submitting the required report of correction or
removal. In the summary MDR, the manufacturer must indicate the check
box of recall in the ``Remedial Action Initiated, Check Type'' in the
electronic Form FDA 3500A.
3. FDA Has Determined That Individual MDR Reporting Is Necessary To
Address a Public Health Issue
If FDA has determined that individual malfunction reports are
necessary to provide additional information and more rapid reporting
for an identified public health issue involving certain devices,
manufacturers must submit reportable malfunction events for those
devices as individual MDRs in compliance with Sec. Sec. 803.50 and
803.52. Under these circumstances, FDA will provide written
notification to manufacturers of relevant devices that individual MDR
submissions are necessary. FDA will provide further written
notification when manufacturers of those devices may resume
participation in summary malfunction reporting.
The requirement to submit individual reports under this condition
is triggered on the date the manufacturer receives the written
notification from FDA. If a manufacturer became aware of reportable
malfunction events before the date that the requirement to submit
individual reports is triggered and a summary report for those events
has not yet been submitted to FDA, then the manufacturer must submit
any of those malfunction events for the identified devices to FDA
within 30-calendar days of receiving notification from FDA.
4. FDA Has Determined That a Device Manufacturer May Not Report in
Summary Reporting Format
FDA may determine that a specific manufacturer is no longer allowed
to participate in the Voluntary Malfunction Summary Reporting Program
for reasons including, but not limited to, failure to comply with
applicable MDR requirements under part 803, failure to follow the
conditions of the program, or the need to monitor a public health
issue. In that case, FDA will provide written notification to the
device manufacturer to submit individual malfunction reports in
compliance with Sec. Sec. 803.50 and 803.52. The requirement to submit
individual reports under this condition is triggered on the date the
manufacturer receives the written notification from FDA. If a
manufacturer became aware of reportable malfunction events before the
date that the requirement to submit individual reports is triggered
under this condition and a summary report for those events has not yet
been submitted to FDA, then the manufacturer must submit those
malfunction events to FDA within 30-calendar days of receiving
notification from FDA.
5. A New Type of Reportable Malfunction Occurs for a Device
If a manufacturer becomes aware of information reasonably
suggesting a reportable malfunction event has occurred for a device
that the manufacturer markets and the reportable malfunction is a new
type of malfunction that the manufacturer has not previously reported
to FDA for that device, then the manufacturer must submit an individual
report for that reportable malfunction in compliance with Sec. Sec.
803.50 and 803.52. After the manufacturer submits this initial
individual report, subsequent malfunctions of this type may be
submitted in summary form according to the reporting schedule in Table
1, unless another individual reporting condition applies.
C. Supplemental Reports
In general, if a manufacturer obtains information required in a
malfunction summary report (see section III.D. describing the required
content of a summary report), that the manufacturer did not provide
because it was not known or was not available when the manufacturer
submitted the initial summary malfunction report, the manufacturer must
submit the supplemental information to FDA in an electronic format in
accordance with Sec. 803.12(a). The supplemental information must be
submitted to FDA by the submission deadline described in the Summary
Malfunction Reporting Schedule (Table 1), according to the date on
which the manufacturer becomes aware of the supplemental information.
Manufacturers must continue to follow the requirements for the content
of supplemental reports set forth at Sec. 803.56(a) through (c),
meaning that on a supplemental or follow up report, the manufacturer
must: (a) indicate that the report being submitted is a supplemental or
follow up report; (b) submit the appropriate identification numbers of
the report that you are updating with the supplemental information
(e.g., your original manufacturer report number and the user facility
or importer report number of any report on which your report was
based), if applicable; and (c) include only the new, changed, or
corrected information.
However, if a manufacturer submits a summary malfunction report and
subsequently becomes aware of information reasonably suggesting that an
event (or events) summarized therein represents a reportable serious
injury or death event, or a new type of reportable malfunction, then
the manufacturer must submit reports as follows: The manufacturer must
submit an initial, individual MDR for the identified serious injury,
death, or new type of reportable malfunction event within 30-calendar
days of becoming aware of the additional information. The manufacturer
must simultaneously submit a supplement to the initial malfunction
summary report reducing the number of events summarized accordingly, so
that the total number of events remains the same.
D. Malfunction Reporting Summary Format
As discussed in section II, we are revising the malfunction summary
reporting format to reflect updates to the
[[Page 70099]]
Form FDA 3500A (Ref. 1) and to FDA's references to MDR adverse event
codes. While some aspects of the format in which manufacturers must
submit their summary reports will change, the information required to
be submitted by participating manufacturers will not.
Manufacturers of devices in eligible product codes who elect to
participate in the Voluntary Malfunction Summary Reporting Program must
submit summary malfunction reports in the format described below. FDA
believes that submission of summary reports in the format described
below will provide the most compact and efficient reporting mechanism
for streamlining malfunction reporting that still provides sufficient
detail for FDA to monitor devices effectively.
Separate summary malfunction reports must be submitted for each
unique combination of brand name, device model, and MDR adverse event
device problem code(s).
Each summary malfunction report must include at least the following
information collected on Form FDA 3500A and must be submitted in an
electronic format:
<bullet> Exemption/Variance Number--Type in ``VMSR''.
<bullet> Describe Event or Problem--The device event narrative must
include a detailed description of the nature of the events and, if
relevant and available, we recommend including a range of patient age
and weight and a breakdown of patient gender, race, and ethnicity.
Inclusion of patient age, weight, gender, race, and ethnicity is not a
required entry for the form; however, FDA recommends including these
descriptors in a text narrative if the information is available and if
a malfunction is more likely to affect a specific group of patients.
<bullet> Brand Name--Include the device brand name.
<bullet> Common Device Name and Product Code--Include the common
name of the device and its product code.
<bullet> Manufacturer Name, City, and State--Add the manufacturer's
name and identify its location.
<bullet> Model Number and other device identifying information--
Enter the device model and/or catalog number and lot number(s) and/or
serial number(s) for the devices that are the subject of the MDR.
Include any device identifier (DI) portion of the unique device
identifier for the device version or model that is the subject of the
MDR.
<bullet> Contact Office (and Manufacturing Site(s) for Devices)--
Enter the name, address, and email of the manufacturer reporting site
(contact office), including the contact name for the summary report
being submitted. Enter the name and address of the manufacturing
site(s) for the device, if different from the contact office.
<bullet> Phone Number of Contact Office--Include a phone number for
the contact office.
<bullet> Combination Products (if applicable)--Check if the report
involves a combination product.
<bullet> Type of Reportable Event--Check ``Malfunction.''
Manufacturers must check the ``Summary Report'' box and identify the
number of events being summarized.
<bullet> Adverse Event Problem--Enter the corresponding codes,
including as many codes as necessary to describe the event problem and
evaluation for the reportable malfunction events that are being
summarized:
[ssquf] ``Medical Device Problem Code''
[ssquf] ``Type of Investigation''
[ssquf] ``Investigation Findings''
[ssquf] ``Investigation Conclusions,'' even if the device was not
evaluated.
<bullet> Additional Manufacturer Narrative--Provide a summary of
the results of the investigation for the reported malfunctions,
including any follow up actions taken, and any additional information
that would be helpful in understanding how the manufacturer addressed
the malfunction events summarized in the report. Enter a breakdown of
the malfunction events summarized in the report: the number of devices
that were returned, the number of devices that were labeled ``for
single use'' (if any), and the number of devices that were reprocessed
and reused (if any).
E. Combination Product Considerations
Device-led combination products are included in this alternative.
The electronic Medical Device Reporting (eMDR) data system and
instructions (Ref. 2) support use of the Voluntary Malfunction Summary
Reporting Program for device-led combination products.
F. Submission Schedule and Logistics
Manufacturers submitting malfunction summary reports or
supplemental reports to a malfunction summary report must use
electronic reporting (Ref. 2) to submit those reports on a quarterly
basis according to the schedule in Table 1. The summary malfunction
report must include the MDR number, which consists of the registration
number of the manufacturer, the year in which the event is being
reported, and a 5-digit sequence number. Information included in a
malfunction summary report must be current as of the last date of the
quarterly timeframe identified in the first column of Table 1.
Table 1--Summary Malfunction Reporting Schedule
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Reportable malfunctions or supplemental
information that you become aware of during Must be submitted to FDA
these timeframes: 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.
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Under Sec. Sec. 803.17 and 803.18, manufacturers are required to
develop, maintain, and implement written MDR procedures and establish
and maintain MDR event files, and those requirements remain applicable
for manufacturers that elect to participate in this program. Among
other things, a manufacturer must develop, maintain, and implement MDR
procedures that provide for timely transmission of complete MDRs to
FDA. (See Sec. 803.17(a)(3).) Manufacturers participating in the
Voluntary Malfunction Summary Reporting Program must update their
internal MDR processes and procedures to provide for submitting summary
malfunction reports within the Summary Malfunction Reporting Schedule.
IV. Program Implementation
The goal of the Voluntary Malfunction Summary Reporting Program is
to permit manufacturers of devices under certain product codes to
report malfunctions on a quarterly basis and in a summary format, as
outlined in the Medical Device User Fee Agreement (MDUFA) IV Commitment
Letter (Ref.
[[Page 70100]]
3), in a manner that provides for effective monitoring of devices and
is beneficial for FDA, industry, and the public. An important part of
this voluntary program is providing clarification to manufacturers
regarding the product codes eligible for the program.
Consistent with the MDUFA IV Commitment Letter (Ref. 3), FDA has
identified eligible product codes for the Voluntary Malfunction Summary
Reporting Program in FDA's Product Classification Database, available
on FDA's website <a href="https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/voluntary-malfunction-summary-reporting-program">https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/voluntary-malfunction-summary-reporting-program</a>. Manufacturers that choose to participate in
quarterly summary reporting through this program will remain
responsible for complying with applicable MDR requirements under part
803 (e.g., requirements to establish and maintain MDR event files under
Sec. 803.18) and quality system requirements under part 820 (21 CFR
part 820) (e.g., the requirement to evaluate, review, and investigate
any complaint that represents an MDR reportable event under Sec.
820.198).
If FDA determines that individual malfunction reports are necessary
from a specific manufacturer or for specific devices, FDA will notify
relevant manufacturers that they must submit individual reports and
provide an explanation for that decision and, as appropriate, the steps
necessary to return to summary, quarterly reporting. The Agency also
notes that, under Sec. 803.19(d), it may revoke or modify in writing
an exemption, variance, or alternative reporting requirement if it
determines that revocation or modification is necessary to protect the
public health.
V. Updating Product Codes for Inclusion Into the Program
FDA recognizes that new product codes will be created in the
future. In general, as explained in the document published in 2018 (83
FR 40973, August 17, 2018), FDA does not intend to consider devices
under product codes in existence for fewer than 2 years to be eligible
for the program, unless the new product code was issued solely for
administrative reasons. However, FDA will periodically evaluate new
product codes after they have been in existence for 2 years to
determine whether they should be added to the list of product codes
eligible for the Voluntary Malfunction Summary Reporting Program. If
FDA determines that a new product code should be added, then it will
grant manufacturers of devices within that product code the same
alternative under Sec. 803.19 for malfunction events associated with
those devices and update FDA's Product Classification database
accordingly to reflect the changes.
Manufacturers can send a request for a product code to be added to
the list of eligible product codes and for manufacturers of devices
within that product code to be granted the same alternative for
malfunction events associated with those devices to the
<a href="/cdn-cgi/l/email-protection#75383127251a191c160c351311145b1d1d065b121a03"><span class="__cf_email__" data-cfemail="1e535a4c4e7172777d675e787a7f3076766d30797168">[email protected]</span></a> mailbox.
VI. Conclusion
In accordance with section 519(a)(1)(B)(i) of the FD&C Act and
Sec. 803.19(d), FDA is modifying the alternative granted to
manufacturers of devices in eligible product codes, as identified in
the FDA's Product Classification Database, available on FDA's website
<a href="https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/voluntary-malfunction-summary-reporting-program">https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/voluntary-malfunction-summary-reporting-program</a>, for the Voluntary Malfunction Summary Reporting Program.
Specifically, we are modifying the malfunction summary reporting format
to enhance consistency with the revised Form FDA 3500A and to update
FDA references to MDR adverse event codes, as well as to make a few
editorial changes for additional clarity. This modification will help
ensure the accuracy and consistency of summary malfunction reporting
information submitted to FDA and thus help protect the public health.
VII. Analysis of Environmental Impact
The Agency has determined under 21 CFR 25.30(h) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
VIII. References
The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-
402-7500, and are available for viewing by interested persons between 9
a.m. and 4 p.m., Monday through Friday; they also are available
electronically at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. References without
asterisks are not on public display at <a href="https://www.regulations.gov">https://www.regulations.gov</a>
because they have copyright restriction. Some may be available at the
website address, if listed. References without asterisks are available
for viewing only at the Dockets Management Staff. Although FDA has
verified the website addresses in this document, please note that
websites are subject to change over time.
1. FDA. MedWatch Form FDA 3500A. Available at: <a href="https://www.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safety-reporting">https://www.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safety-reporting</a>.
2. FDA. Electronic Medical Device Reporting (eMDR) website.
Available at: <a href="https://www.fda.gov/industry/fda-esubmitter/electronic-medical-device-reporting-emdr">https://www.fda.gov/industry/fda-esubmitter/electronic-medical-device-reporting-emdr</a>.
3. * FDA. Medical Device User Fee Agreement IV Commitment Letter.
Available at: <a href="https://www.fda.gov/downloads/ForIndustry/UserFees/MedicalDeviceUserFee/UCM535548.pdf">https://www.fda.gov/downloads/ForIndustry/UserFees/MedicalDeviceUserFee/UCM535548.pdf</a>.
Dated: August 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-19414 Filed 8-28-24; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on August 29, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.