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CooperVision’s Puerto Rico facility has received an FDA warning letter for inadequate investigations into nonconformities and other GMP issues. While the company will need to improve staff training, the letter should not hurt operations or approvals, an analyst says. Read More
Manufacturers will get more guidance on how to communicate off-label uses by the end of the year, the FDA said in a June 6 response to two citizen petitions. Read More
Results from Team-NB’s third member survey show the number of ISO 13485 certificates issued to devicemakers last year declined by 10 percent. Read More
The FDA’s recent approval of a gene-based diagnostic to improve blood matching before transfusions is just the first step for a technology that could vastly improve patient care, a panel of experts said recently. 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An audit of the FDA’s device review process recommends that the agency analyze the root cause of withdrawn submissions and create mechanisms to reduce their occurrence — good news for devicemakers fed up with inefficient reviews.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
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