CDRHNew
Date: August 20, 2014
The following new items were added to the CDRH web pages on August 19, 2014. Previous CDRH New Items can be found on the CDRHNew Page.
- Federal Register: Brain-Computer Interface Devices for Patients With Paralysis and Amputation; Public Workshop; Request for Comments
- Class I Medical Device Recall: Cardiovascular Systems Diamondback 360 Peripheral Orbital Atherectomy System - Sheath May Fracture During Use
- Consumer Information on: Cologuard - P130017
- Extension Letter to Class III Contact Lens and Intraocular Lens Labelers - August 15, 2014
- FDA Voice Blog: Providing Easy Access to Medical Device Reports Submitted to FDA since the Early 1990s
- Federal Register: Food and Drug Administration Decisions for Investigational Device Exemption Clinical Investigations: Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff; Availability