CDRH New Update

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.govon May 2, 2019. To view listings for other dates, see CDRH New - News and Updates.

Patient Preference Information (PPI) in Medical Device Decision-Making Priority List of Patient Preference-Sensitive Areas Patient Preference-Sensitive Areas: Using Patient Preference Information in Medical Device Evaluation Medical Device Reporting (MDR): How to Report Medical Device Problems Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities Transcript posted for March 21, 2019 Neurological Devices Panel of the Medical Devices Advisory Committee Meeting Statement from FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health on FDA’s new efforts to protect women’s health and help to ensure the safety of breast implants FDA In Brief: FDA advances the science of patient input by seeking specific feedback on patient preferences that may impact regulatory decisions on medical devices Federal Register: List of Patient Preference-Sensitive Priorities; Establishment of a Public Docket; Requests for Comments