📋FDA Notice on Postmarket Surveillance of Medical Devices
Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarket Surveillance of Medical Devices
Summary
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection requirements for postmarket surveillance of medical devices.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The regulation involves compliance requirements for medical device manufacturers regarding postmarket surveillance information collection. This means businesses in the medical device sector must adapt their processes to align with FDA's updated requirements, impacting operational costs and regulatory compliance.