📋FDA Seeks Comments on Medical Device Reporting Regulations
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Reporting
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 revision 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 collections associated with requirements for medical device reporting for user facilities, manufacturers, importers, and distributors of medical devices.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The text announces a solicitation for public comments on the proposed collection of information regarding medical device reporting, signifying compliance and regulatory requirements for manufacturers, user facilities, and importers of medical devices. This affects operational compliance and potential reporting burdens for involved businesses.