2024-19414. Medical Devices and Device-Led Combination Products; Voluntary Malfunction Summary Reporting for Manufacturers
Table 1—Summary Malfunction Reporting Schedule
Reportable malfunctions or supplemental information 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.
Document Information
- Published:
- 08/29/2024
- Department:
- Food and Drug Administration
- Entry Type:
- Rule
- Action:
- Notification; order granting modification to alternative.
- Document Number:
- 2024-19414
- Dates:
- This modification applies to voluntary summary reports for reportable malfunction events that manufacturers become aware of on or after August 29, 2024.
- Pages:
- 70096-70100 (5 pages)
- Docket Numbers:
- Docket No. FDA-2017-N-6730
- PDF File:
- 2024-19414.pdf
- Supporting Documents:
- » List of References - Voluntary Malfunction Summary Reporting Program fro Manufacturers
- » Ref. 1, FDA, Medical Device Reporting--Alternative Summary Reporting (ASR) Program Guidance for Industry
- » Ref. 2, Food and Drug Administration, MDR Adverse Event Codes
- » Ref. 3, FDA Form 3500A - MEDWATCH
- » Ref. 4, MDUFA IV Performance Goals and Procedures. Fiscal Years 2019 through 2022 Commitment Letter
- » Ref. 5, Appedix A, Case Examples of Summary Malfunction Reporting
- » Ref. 6, Food and Drug Administration, Electronic Medical Device Reporting
- CFR: (1)
- 21 CFR 803