The FDA has reclassified antigen-based rapid influenza virus antigen detection test systems (RIDTs) from Class I to Class II devices and has introduced special controls aimed at improving the quality…

FDA inspectors hit Covidien with a Form 483 for inadequate complaint evaluation and process control procedures, as well as failure to ensure appropriate design and installation of manufacturing equipment. Source:…

Nomax received a warning letter for failing to evaluate complaints, document corrective and preventive actions, and committing other violations. Source: The GMP Letter

Zimmer Biomet’s Warsaw, Ind., medical device facility was hit with a massive, 58-page Form 483 arising from an inspection carried out from September to November of 2016. Source: The GMP…

The China Food and Drug Administration (CFDA) has issued new guidance on quality control, finished product inspection, and other procedures for medical devices Source: The GMP Letter

The FDA and the Department of Homeland Security have flagged cybersecurity weaknesses in some St. Jude Medical implantable cardiac devices used with the company’s Merlin@home transmitters. Source: The GMP Letter