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European regulators have granted Edwards Lifesciences’ next-generation Intuity Elite valve system CE Mark approval, the Irvine, Calif., devicemaker said Friday. Read More
The FDA has finalized a guidance on interactive reviews to include commitments it made in the MDUFA III commitment letter and to expand use of the process. Read More
House and Senate lawmakers passed separate bills to extend the current sustainable growth rate patch and provide other benefits to diagnostics manufacturers. Read More
Beginning this month, all devicemakers holding CE certificates for devices classified as Class IIa and above should be prepared for unannounced quality system visits by notified body inspectors. Read More
The International Medical Device Regulators forum will immediately suspend auditing organizations from the Medical Device Single Audit Program if there is evidence of any wrongdoing during a facility audit. Read More
The FDA has closed out a warning letter issued to online genetics testing firm 23andMe, following the company’s agreement to take its health-related analysis off the market. Read More
Manufacturers should update their medical device tracking procedures to account for unique device identifiers, the FDA says in updated guidance. Read More
A federal panel is recommending that the FDA retain regulatory authority over high-risk device software, while loosening regulations around two categories considered to be lower risk. Read More