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As the clock ticks down for high-risk devices to comply with the FDA’s unique device identifier rule, the first organization accredited to issue UDIs is offering devicemakers some advice. Read More
Medtronic Navigation of Louisville, Colo., received an FDA Form 483 for issues related to design validation, process validation, CAPAs, acceptance activities and nonconforming product. Read More
All devicemakers holding CE certificates for Class IIa medical devices and higher should be prepared for unannounced quality system visits by notified body inspectors. Read More
Manufacturers should update their medical device tracking procedures to account for unique device identifiers, the FDA says in updated guidance. Read More
An FDA warning letter last year to Biosense Technologies was a heads-up to mobile app developers, but “the fears of the mobile app industry … that the letter to Biosense represented some new trend of aggressive FDA enforcement” have not come true, one expert says. Read More