CDRH New - October 25, 2019

CDRH New October 25, 2019 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on October 24, 2019. To view listings for other dates, see CDRH New - News and Updates.

Presentation and Transcript added to Webinar: Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions - Final Guidance Federal Register: Orthopedic Devices; Classification of Orthopedic Surgical Instrumentation Designed for Osteochondral Implants with Press-Fit Fixation Federal Register: Physical Medicine Therapeutic Devices; Classification of the Internal Therapeutic Massager Federal Register: Administrative Procedures for Clinical Laboratory Improvement Amendments Categorization Federal Register: Exemptions from Premarket Notification: Class II Devices