📑FDA Notice on Electronic Submissions of Medical Device Registration
Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Submissions of Medical Device Registration and Listing
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 associated with electronic submission of medical device registration and listing.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The notice pertains to compliance requirements for medical device establishments regarding electronic submissions for registration and listing, critical for industry members. Businesses must prepare for changes in information collection practices affecting regulatory compliance.