Medmarc Blog (blog.medmarc.com)
Posts about
Food, Drug and Cosmetic Act (FDCA)
FDA’s Posts Final Guidance for Remanufacturing
May
14,
2024
The FDA has issued a final guidance for servicing and remanufacturing services for medical devices, which will end the agency’s enforcement discretion for remanufacturing activities. Manufacturers...
FDA Proposes End to Enforcement Discretion for Lab-Developed Tests
October
09,
2023
The FDA has released a draft rule for regulation of lab-developed tests (LDTs) that would terminate the existing policy of enforcement discretion over a period of approximately four years. The...