CDRH New - February 13, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on February 12, 2020. To view listings for other dates, see CDRH New - News and Updates.

Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions - Guidance for Industry and Food and Drug Administration Staff Class I Recall: Medtronic Recalls MiniMed Insulin Pumps for Incorrect Insulin Dosing Three New CDRH Learn Modules: Overview of the 510(k) Process: Guide for Third Party Reviewers, Deficiency Writing for Third Party Reviewers, and Deficiency Writing for Third Party Reviewers: Examples Federal Register: Peripheral Vascular Atherectomy Devices--Premarket Notification Submissions Federal Register: Request for Nominations: Individuals and Industry Organizations for the Patient Engagement Advisory Committee