We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Upcoming events in the coming weeks include four FDA advisory committee meetings as well as the WCG MAGI Clinical Research Conference and webinars on the FDA’s sterilization pilot and design control. Read More
The Case for Quality (CfQ) — an FDA initiative in which the agency works closely with the public-private partnership the Medical Device Innovation Consortium (MDIC) — has key programs coming to fruition in its mission to get the industry to focus on continuous improvement in their quality operations. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. Read More
While most comments on the FDA’s draft guidance on providing predetermined change plans for devices that include use of AI or machine learning (ML) offer improvements of one sort or another, one commenter doesn’t believe such change plans are even needed. Read More
Deeply embedded supply chain challenges, such as “just in time” manufacturing methodology and sole sourcing to maximize profit, are key drivers of low inventories and offshoring, said Mark Abdoo, associate commissioner of FDA’s Office for Global Policy and Strategy (OGPS) in a recent speech. Read More
Certain recalled extended dwell catheters from Teleflex, and its subsidiary Arrow International, have a risk of separating while still in the blood vessel, resulting in the FDA deeming the recall Class I because of the risk of serious injury or death. Read More
Over the past week, the FDA issued final guidances on direct-to-consumer promotional labeling and advertisements and treatment for chronic rhinosinusitis with nasal polyps. Draft guidances were issued on psychedelic drugs, orthopedic implants and wholesaling under section 503B. Read More
Significant moves to limit amounts of the known human carcinogen ethylene oxide (EtO), commonly used to sterilize medical devices, will adversely affect delicate supply chains, making it difficult for hospitals to access devices needed to treat cardiac ailments, diabetes and Parkinson’s disease as well as medical supplies needed for surgery. Read More