CDRH New Update

CDRH New September 16, 2019 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on September 13, 2019. To view listings for other dates, see CDRH New - News and Updates.

Ethylene Oxide Sterilization for Medical Devices (Updated) 24 Hour Summary posted for September 10, 2019 Patient Engagement Advisory Committee meeting Federal Register: Medical Devices; Exemption From Premarket Notification: Class II; Powered Wheeled Stretcher; Request for Comments The Special 510(k) Program - Guidance for Industry and Food and Drug Administration Staff Format for Traditional and Abbreviated 510(k)s - Guidance for Industry and FDA Staff The Abbreviated 510(k) Program - Guidance for Industry and Food and Drug Administration Staff Refuse to Accept Policy for 510(k)s - Guidance for Industry and Food and Drug Administration Staff Webinar - The Special 510(k) Program: Final Guidance Class I Recall: Allergan Recalls Natrelle Biocell Textured Breast Implants Due to Risk of BIA-ALCL Cancer Ciertas Bombas de Insulina Medtronic MiniMed Presentan Posibles Riesgos de Ciberseguridad: Mensaje de Seguridad de la Administración de Alimentos y Drogas (FDA, siglas en inglés)