The Food and Drug Administration (FDA) may be closing in on solving one of its perennial regulatory problems, namely, the absence of a workable regulatory pathway for devices that seek to use older, mainly generic drugs in innovative ways.
The Food and Drug Administration (FDA) recently released statitistics regarding its enforcement actvities for FY 2016. Of note, the number of warning letters issued by the Center for Devices and Radiological Health (CDRH), the FDA center that governs medical devices, reached an 8 year low, down 50% from FY 2015.
On September 21, 2016, FDA issued a draft guidance titled “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices – Draft Guidance for Industry and Food and Drug Administration Staff.” This draft guidance describes FDA’s suggested steps for seeking approval of an antimicrobial drug and any related antimicrobial susceptibility test (AST) devices in order
Based on stakeholder comments raising serious concerns about a significant increase in the number of new 510(k) submissions that would be required for minor changes to 510(k)-cleared devices, CDRH Director, Jeffrey Shuren, recently signaled that the medical device center is revisiting its 27 July 2011 proposed draft guidance, 510(k) Modifications: Deciding When to Submit a