CDRH New

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on October 23, 2019. To view listings for other dates, see CDRH New - News and Updates.

Breast Implants - Certain Labeling Recommendations to Improve Patient Communication - Draft Guidance for Industry and Food and Drug Administration Staff Information on Breast Implants Press Release: Statement on the agency’s continued efforts to protect women’s health and enhance safety information available to patients considering breast implants Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Postmarket Surveillance of Medical Devices Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Premarket Approval of Medical Devices Federal Register: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 052 Federal Register: Guidance: Breast Implants--Certain Labeling Recommendations to Improve Patient Communication