Medical Devices and Device-Led Combination Products; Voluntary Malfunction Summary Reporting for Manufacturers
fda-device · Food and Drug Administration · Rule · Published 2024-08-29 · 89 FR 70096
Document
Document number
2024-19414
Federal Register citation
89 FR 70096
CFR reference
21 CFR 803
Type
Rule
Action
Notification; order granting modification to alternative.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2024-08-29
HHS docket
Docket No. FDA-2017-N-6730
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."