The FDA rapped Newton, North Carolina devicemaker Sarstedt after a June 28 to July 2, 2018 inspection revealed deficiencies in its document change and labeling procedures. Source: The GMP Letter

Australia’s Therapeutic Goods Administration issued two new guidances, one proposing a regulatory framework for personalized medical devices and the other on regulation of software, including software as a medical device…

The FDA hit Imaging Biometrics with a Form 483, calling the Elm Grove, Wisconsin healthcare software developer out for its medical device reporting procedure and complaint records. Source: The GMP…

The FDA cited Acorda Therapeutics’ Chelsea, Massachusetts manufacturing facility for its handling of discrepancy investigations observed during a June 4-18, 2018 inspection. Source: The GMP Letter

The FDA warned La Mesa, California-based devicemaker Total Thermal Imaging for marketing an unapproved device for breast cancer screening. Source: The GMP Letter

Australia’s Therapeutic Goods Administration is seeking feedback from devicemakers on how personalized devices should be regulated. Source: The GMP Letter

With a looming hard Brexit exit less than 60 days away, BSI is warning devicemakers that their CE certificates in the UK could become invalid if the UK and EU…

The FDA rapped six device facilities for a variety of deficiencies identified during inspections, including problems with CAPAs and medical device reporting. Source: The GMP Letter

China’s National Medical Products Administration is increasing its scrutiny of foreign manufacturers and will begin routine, risk-based inspections of foreign facilities to confirm they are in compliance with Chinese regulations.…

The Healthcare and Public Health Sector Coordinating Council (HSCC) has developed a new guide for managing the security of medical devices. Source: The GMP Letter