CDRH: Updated Draft Guidances – 510(k) Program
October 30th, 2023 – Written by Mitchell Gorthy Summary On October 26th, the FDA’s Center for Devices and Radiological Health (CDRH) updated draft guidances to modernize their 510(k) program. Employees from the CDRH’s Office of Product Evaluation and Quality gave brief overviews of each draft guidance. Regulatory Advisor, Megha Reddy, explained “Best Practices for Selecting … Read more