FDA Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance (Catapult’s regulatory round-up – february 2024)
The FDA has issued a draft guidance to propose selected updates to the FDA guidance document “Medical Device User Fee Small Business Qualification and Certification”. It provides additional information on how small businesses can show financial hardship to qualify for a small business registration fee waiver. The existing Small Business Guidance remains in its current form, until this draft guidance is finalized. FDA is seeking feedback on revisions proposed in this select update. Comments can be submitted until 23 April 2024.
Published on the 5th of March 2024 in Catapult’s regulatory round-up for february 2024.
OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (5 novembre 2024). FDA Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance (Catapult’s regulatory round-up – february 2024). ELSIBI. Consulté le 19 janvier 2025 à l’adresse https://doi.org/10.58079/12mil
