CDRH New Update

The following new items were added to the CDRH web pages on September 27, 2018. Previous CDRH New items can be found on the CDRH New webpage. Consumer Information on: Eluvia Drug-Eluting Vascular Stent System - P180011 Caution When Using Pen Needles to Inject Medicines: FDA Safety Communication Labeling Request Letter to Pen Needle Manufacturers - September 27, 2018 The Special 510(k) Program - Draft Guidance for Industry and Food and Drug Administration Staff