CDRH New Update

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

Use of the Stryker Wingspan Stent System Outside of Approved Indications Leads to an Increased Risk of Stroke or Death: FDA Safety Communication Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions - Guidance for Industry and Food and Drug Administration Staff Unique Device Identification: Convenience Kits - Guidance for Industry and Food and Drug Administration Staff Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices - Guidance for Industry and Food and Drug Administration Staff Transcripts posted for March 25-26, 2019 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee meeting Webinar - Unique Device Identification: Convenience Kits Final Guidance - May 21, 2019 Federal Register: Medical Device User Fee Small Business Qualification and Certification Federal Register: Unique Device Identification: Convenience Kits Federal Register: Characterization of Ultrahigh Molecular Weight Polyethylene Used in Orthopedic Devices Federal Register: Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions