Requests that the FDA to take administrative action relative to the operable definition of “malfunction” as it applies to Medical Device Reporting regulations. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2025-P-1100

Requests that the FDA to take administrative action relative to the operable definition of “malfunction” as it applies to Medical Device Reporting regulations.

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensApr 21, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Response Letter	Jul 20, 2026	--

Comment Statistics

Total Comments

Keywords

CDRH

Citizen Petition

to take

administrative action relative to the operable

definition of malfunction as it applies to

Medical Device Reporting regulations

CLOSED

Data from Regulations.gov