CDRH New Update

CDRHNew

Date: June 22, 2017

The following new items were added to the CDRH web pages on June 21, 2017. Previous items can be found on the CDRHNew Page.

• Class I Medical Device Recall: Vascular Solutions Inc. Recalls Venture Catheters due to Excess Material that May Split or Separate During Use
• Federal Register: Use of Electronic Records and Electronic Signatures in Clinical Investigations Under Part 11--Questions and Answers; Draft Guidance for Industry; Availability