CDRH New

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on Month DD, 2019. To view listings for other dates, see CDRH New - News and Updates.

Providing Regulatory Submissions for Medical Devices in Electronic Format - Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act - Draft Guidance for Industry and Food and Drug Administration Staff