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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
There has been a steady uptick in the number of FDA 483s that cite inadequate supplier controls — from 84 in 2011, to 110 in 2012 and 126 last year. Read More
Manufacturers should update their medical device tracking procedures to account for unique device identifiers, the FDA says in updated guidance. Read More