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Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance Draft Guidance for Industry and Food and Drug Administration Staff February 2024
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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All written comments should be identified with this document's docket number: FDA-2018-D-1873
- Docket Number:
- FDA-2018-D-1873
- Issued by:
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Guidance Issuing OfficeCenter 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FDA has developed this draft guidance to propose select updates to the FDA guidance document Medical Device User Fee Small Business Qualification and Certification.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 The existing guidance on small business user fees remains in effect, in its current form, until this draft guidance is finalized.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.