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While most comments on the FDA’s draft guidance on providing predetermined change plans for devices that include use of AI or machine learning (ML) offer improvements of one sort or another, one commenter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
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
The FTC and the DOJ are pushing for rules that would require companies planning a merger or acquisition to forestall consummation until federal agencies have had enough time to more deeply investigate whether the transaction would violate antitrust laws and “harm the American public.” Read More
The European Academy of Paediatrics (EAP) and 22 other European medical associations have written to the European Commission (EC) to warn that critical pediatric medical devices are being squeezed out of the market by the high cost of implementing the EU Medical Device Regulation 745/2017 (EU MDR). Read More
A new FDA draft guidance details what to include in a submission for regulatory approval of patient-matched guides used in pre-surgical planning for 3-D printed orthopedic implant systems such as knee or hip replacements. Read More
When communicating about the efficacy and risks of prescription and OTC drugs directly to consumers, quantitative information “can improve consumers’ accuracy in estimating the drug’s benefits and risks” and should be “accurate and understandable” says the FDA in a final guidance issued Tuesday. Read More