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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
Abbott’s corrective and preventive action (CAPA) activities and results have not been adequately documented, FDA investigators found during an inspection at the company’s Arecibo, Puerto Rico, location. Read More
Failure to review and submit medical device reports (MDR) within 30 days of receipt is the key observation in an FDA form 483 received by Philips North America following an Oct. 11-27, 2022, inspection of its Bothell, Wash., facility. Read More
A lack of procedures for receiving, reviewing and evaluating complaints by a formally designated unit is one of nine observations that an FDA investigator made during a Dec. 5-9, 2022, inspection of San Diego-based Integrated Orbital Implants. 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
Upcoming events in the coming weeks include three FDA advisory committee meetings as well as webinars on the FDA's sterilization pilot and design control. 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A new FDA draft guidance details what to include in a submission for regulatory approval of patient-matched guides used in pre-surgical planning for 3-D printed orthopedic implant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