FDA Releases Draft Guidances on 510(k) Submissions
On September 6, 2023, the U.S. Food & Drug Administration (FDA) released three draft guidance documents to provide updated recommendations on the 510(k) Program to “keep pace with the increasing...
FDA Releases Draft Guidance for Studies of Medical Devices for Opioid Use Disorder
The U.S. Food and Drug Administration (FDA) recently released draft guidance regarding clinical considerations for studies of medical devices intended to treat opioid use disorder (OUD). According to the FDA’s...
