Business · 12/04/2005Updated: 10/17/2026 · 1 min read
FDA Releases Guidance on Resolving Premarket Review Disputes for Combination Products
Summary
The FDA has made available a guidance document to help resolve disputes about the timeliness of premarket review for combination products, a process overseen by the Office of Combination Products under the Medical Device User Fee and Modernization Act of 2002.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →