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

Hong Kong’s Department of Heath issued safety warnings for Boston Scientific Ingevity MRI endocardial pacing leads and Percuflex Urinary Diversion stents, Draeger Medical GmbH Oxylog 3000 and Oxylog 3000plus ventilators,…

United Contact Lens received a warning letter for failing to test finished products and establish written customer complaint procedures. Source: The GMP Letter

Hoggan Scientific LLC was hit with a Form 483 after an inspection revealed a lack of adequate procedures for design control, corrective and preventive actions, complaint evaluation, and other issues.…

Final guidance on reducing cross-contamination from irrigation valves and accessories for flexible gastrointestinal endoscopes adds a new section on testing for backflow prevention. Source: The GMP Letter

CryoSurgery Inc. landed a Form 483 for poorly documented acceptance activities and inadequate procedures for ensuring the quality of received products. Source: The GMP Letter

Manufacturing-related provisions in the recently enacted 21st Century Cures Act establish a program for “breakthough” devices, exempt some categories of medical software from regulation as a medical device, and require…

Aesculap Inc. was cited in a Form 483 for neglecting to file timely medical device reportable (MDR) events and establish timely corrective and preventive actions in response to complaints. Source:…

Precision Interconnect was hit with a Form 483 for poor corrective and preventive action (CAPA) procedures and failing to ensure that products conformed to requirements. Source: The GMP Letter