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The FDA gave sponsors of combination drug/device products another year to get their IT affairs in order before complying with new postmarket safety reporting requirements. Read More
The FDA issued final guidance recommending what information devicemakers should include in test report summaries, test protocols and complete rest reports for non-clinical bench performance testing for their premarket submissions. Read More
The FDA is considering a total product lifecycle monitoring approach to emerging artificial intelligence devices, the agency said in a proposed regulatory framework. Read More
A trade group representing hybrid drug- and device-makers is urging the FDA to draw bright lines among the agency’s centers as it considers voluntary quality standards. Read More
The FDA cited three devicemakers for nonconforming products, documentation failures, inadequate CAPAs and numerous other problems found during agency inspections. Read More
The FDA issued a draft guidance and proposed order designed to ensure the safe and effective use of surgical staplers and staples for internal use. Read More
The European Commission released long-awaited guidance on Eudamed (the European Database on Medical Devices) and the device nomenclature system that will be used for the EU’s new medical device and in vitro diagnostic regulations. Read More
Abaxis was hit with an FDA warning letter over changes it made to a potassium assay used with its chemistry analyzer device that caused the product to be adulterated and misbranded. Read More
The FDA issued a warning letter to TEI Biosciences’ for “systemic” quality failures the agency found during an Oct. 9 to Nov. 2, 2018, inspection of its Boston, Mass., facility. Read More
MedTech Europe is warning European regulators that the EU’s new regulatory system for devices won’t be ready on time and said the delay will jeopardize patient lives. Read More