Business · 05/06/2025Updated: 10/17/2026 · 1 min read
FDA Announces Draft Guidance on Transfer of 510(k) Clearance
Summary
The FDA has released a draft guidance document addressing frequently asked questions about transferring 510(k) clearance from one holder to another, providing information for industry and FDA staff.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →