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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
AdvaMed has hung up its shingle at an office in Shanghai, hoping to play a more proactive role in regulatory and reimbursement policies impacting devicemakers in China. Read More
The FDA’s process for developing guidance documents needs a major revamp to speed efforts along and integrate feedback from stakeholders earlier, devicemakers and CDRH officials concluded during a Thursday public workshop. Read More