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An audit of the FDA’s device review process recommends that the agency analyze the root cause of withdrawn submissions and create mechanisms to reduce their occurrence — good news for devicemakers fed up with inefficient reviews.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
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
A chief architect of a 2007 law promoting the development of medical devices for children has asked the FDA to provide evidence the agency is making progress on meeting its goals. Read More
Stryker will use ongoing inquiries to continually assess its supplies for conflict minerals, according to a new supply chain policy outlined in the company’s first conflict minerals disclosure report to the SEC. Read More
The FDA is trying to encourage mobile app and web developers to give wide distribution to adverse events information by providing the data in an easy-to-use electronic format. Read More
Manufacturers of some cellulite-reduction devices may have an easier time bringing their products to market, thanks to an FDA reclassification order. Read More