The FDA has withdrawn a proposed rule that would have required manufacturers to submit labels and package inserts in electronic format for certain home-use medical devices.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…
The FDA cited eight drugmakers for a variety of quality and other violations observed during agency inspections. Source: Drug GMP Report
The FDA denied a petition from several pharmaceutical and outsourcing facilities urging the agency to keep implantable testosterone pellets off its Difficult to Compound list — but noted that so…
Generic drugmakers urged the FDA to allow for more flexibility in draft guidance on product identifiers under the Drug Supply Chain Security Act (DSCSA). Source: Drug GMP Report