FDA’s Center for Devices and Radiological Health called for feedback from stakeholders on its priorities for developing guidance for the year ahead. Source: The GMP Letter

Health Canada released a three-part action plan aimed at improving how devices get on the market, strengthening monitoring and providing more information to consumers about the devices they use. Source:…

The European Association for Medical Devices of Notified Bodies (Team-NB) is sounding alarms over the shortage of notified bodies to conduct audits and certify devicemakers in time to comply with…

Contract manufacturer Thatcher Company failed to exercise appropriate controls over computers and related systems to assure that changes in production were only instituted by authorized personnel, FDA inspectors found during…

Lax medical device reporting and CAPA procedures as well as a host of other quality issues were uncovered during a July 31 to Aug. 2 FDA inspection of LED Intellectual…

FDA inspectors found shoddy process controls and a lack of validation documentation in a Sept. 17 to Sept. 21 inspection of Footprint Medical’s San Antonio, Texas facility. Source: The GMP…

Health Canada released guidance for devicemakers on how to comply with premarket cybersecurity requirements. Source: The GMP Letter

International medical device associations rejected a recent report by the International Consortium of Investigative Journalists (ICIJ), which pointed to inadequate oversight of devices globally. Source: The GMP Letter

The FDA issued draft guidance to clarify radiation control regulations for diagnostic x-ray systems and their major components, including recordkeeping, reporting, manufacturing, importing and installation requirements for “electronic products.” Source:…

Seven months after issuing a Form 483 to MiBo Medical Group following an inspection of its Dallas, Texas facility, the FDA warned the devicemaker that it had not fully addressed…