Johnson & Johnson agreed to settle consumer complaints of defective artificial hips for more than $400 million. Source: The GMP Letter

Australia’s Therapeutic Goods Administration is reviewing how it regulates software as a medical device (SaMD) and has issued guidance on its latest thinking. Source: The GMP Letter

The FDA issued separate draft guidances on blood glucose monitors used in health care settings and on over-the-counter products used in the home. When finalized, they will replace guidances the…

The FDA has withdrawn a proposed rule that would have required manufacturers to submit labels and package inserts in electronic format for certain home-use medical devices. Source: The GMP Letter

Monteris is releasing a new version of its NeuroBlate probe to address a problem with overheating of its magnetic resonance-guided laser thermal therapy device. The new probe is equipped with…

The FDA plans to continue building out its National Evaluation System for health Technology (NEST) and it is increasing its focus on device therapies unique to women, Commissioner Scott Gottlieb…

The FDA flagged seven devicemakers for quality system and other failures observed during inspections. Source: The GMP Letter

The FDA hit three foreign device manufacturers with warning letters, calling the firms out for quality system violations that led to adulterated products. Source: The GMP Letter

The FDA posted an update on its Accreditation Scheme for Conformity Assessment (ASCA) pilot, which aims to streamline conformity assessments for medical device submissions that meet yet-to-be-announced standards. Source: The…

The FDA said it will allow device manufacturers of Class I and unclassified devices another two years to comply with its unique device identification system requirements, which are being phased…