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GUIDANCE DOCUMENT

Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance Draft Guidance for Industry and Food and Drug Administration Staff February 2024

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2018-D-1873

Docket Number:
FDA-2018-D-1873
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

FDA has developed this draft guidance to propose select updates to the FDA guidance document Medical Device User Fee Small Business Qualification and Certification.  This guidance provides additional information for the granting of the small business registration fee waiver. The existing guidance on small business user fees remains in effect, in its current form, until this draft guidance is finalized. FDA is seeking feedback on revisions proposed in this select update.

 
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