9 Jun 2025
💼FDA Notice on Medical Device User Fee Small Business Certification
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Small Business Qualification and Certification
Summary
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The text details the FDA’s information collection related to medical device user fee qualifications, which directly affects small businesses seeking fee waivers and certifications. It outlines the requirements for qualifying as a "small business," thus influencing financial obligations for these entities.