Link to episode on Apple Podcasts
A play-by-play of the latest FDA CDRH guidance CDRH entitled “General Wellness: Policy for Low Risk Devices.” Learn what defines a low-risk general wellness product, and how to tell if YOUR product falls under this guidance. Comments on this draft are open for 30 days starting January 20, 2015. Call Frestedt Inc. if you have questions about this guidance and want to discuss your product.
To read the full guidance, visit:
To learn more about the Center for Devices and Radiological Health, visit:
To learn more about the FD&C Act, visit:
Federal Food, Drug, and Cosmetic Act (FD&C Act) | FDA