[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 [www.gpo.gov]
[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 
(https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm) 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:
     Use of dedicated fields to identify the report as a VMSR 
summary malfunction report. Instead of using XML tags `` XXX 
'' 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.
     Update the adverse events code references, from Method, 
Results and Conclusions to ``Type of Investigation'', ``Investigation 
Findings'', and ``Investigation Conclusions''.
     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 (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm), 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:
     Exemption/Variance Number--Type in ``VMSR''.
     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.
     Brand Name--Include the device brand name.
     Common Device Name and Product Code--Include the common 
name of the device and its product code.
     Manufacturer Name, City, and State--Add the manufacturer's 
name and identify its location.
     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.
     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.
     Phone Number of Contact Office--Include a phone number for 
the contact office.
     Combination Products (if applicable)--Check if the report 
involves a combination product.
     Type of Reportable Event--Check ``Malfunction.'' 
Manufacturers must check the ``Summary Report'' box and identify the 
number of events being summarized.
     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.

     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:
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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 https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/voluntary-malfunction-summary-reporting-program. 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 
[email protected] 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 
https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/voluntary-malfunction-summary-reporting-program, 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 https://www.regulations.gov. References without 
asterisks are not on public display at https://www.regulations.gov 
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: https://www.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safety-reporting.
2. FDA. Electronic Medical Device Reporting (eMDR) website. 
Available at: https://www.fda.gov/industry/fda-esubmitter/electronic-medical-device-reporting-emdr.
3. * FDA. Medical Device User Fee Agreement IV Commitment Letter. 
Available at: https://www.fda.gov/downloads/ForIndustry/UserFees/MedicalDeviceUserFee/UCM535548.pdf.

    Dated: August 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-19414 Filed 8-28-24; 8:45 am]
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