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Bowing to industry pressure, the FDA said Thursday it is withdrawing a rule to move cranial electrotherapy stimulators to Class III and will continue to regulate the devices in Class II with special controls. Read More
An audit of the FDA’s device review process recommends that the agency analyze the root cause of withdrawn submissions and create mechanisms to reduce their occurrence — good news for devicemakers fed up with inefficient reviews. Read More
The FDA has provided devicemakers with nitty-gritty details on how to set up and use the Global Unique Device Identification Database, a key component of the universal tracking system set to take effect for Class III implantable devices on Sept. 24. Read More
Coronary device company HeartWare International said Wednesday that it received an FDA warning letter related to the company’s Miami Lakes, Fla., manufacturing facility. Read More
Cook Vascular was handed an FDA warning letter for marketing the Cook Evolution RL and the Shortie RL Bi-directional Dilator Sheath Sets without marketing clearance or approval. Read More
BALTIMORE — Devicemakers in the process of setting unique device identification codes with the FDA may want to bake in some extra time, agency officials say. Read More