Medical Devices and Device-Led Combination Products; Voluntary Malfunction Summary Reporting for Manufacturers

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <CFR>21 CFR Part 803</CFR> <DEPDOC>[Docket No. FDA-2017-N-6730]</DEPDOC> <SUBJECT>Medical Devices and Device-Led Combination Products; Voluntary Malfunction Summary Reporting for Manufacturers</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, Department of Health and Human Services (HHS). <HD SOURCE="HED">ACTION:</HD> Notification; order granting modification to alternative. <SUM> <HD SOURCE="HED">SUMMARY:</HD> 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.” </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This modification applies to voluntary summary reports for reportable malfunction events that manufacturers become aware of on or after August 29, 2024. </EFFDATE> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> 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. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> 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 (§§ 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 § 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 § 803.19(c)). In accordance with section 519(a)(1)(B)(i) of the FD&C Act and § 803.19, FDA granted to manufacturers of devices in eligible product codes, as identified in the FDA Product Classification Database ( <E T="03">https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm</E> ) 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 <E T="04">Federal Register</E> (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. <HD SOURCE="HD1">II. Modification to Malfunction Summary Reporting Format for the Voluntary Malfunction Summary Reporting Program</HD> Under § 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 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 § 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 “<NOE> XXX <NOE>” in the “Describe Event or Problem” section of Form FDA 3500A, manufacturers must use the following fields: In the “Exemption/Variance Number” field, include the term “VMSR.” 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. <HD SOURCE="HD1">III. Voluntary Malfunction Summary Reporting Program</HD> 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 § 803.19, FDA has granted the manufacturers of devices within eligible product codes, as identified in FDA's Product Classification Database ( <E T="03">https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm</E> ), an alternative to the reporting requirements at §§ 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. <SU>1</SU> <FTREF/> 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 ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 34k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━