The International Organization for Standardization released a new standard to help devicemakers improve their risk management. Source: The GMP Letter

Health Canada has finalized guidance on software as a medical device (SaMD) that clarifies how it fits into the agency’s regulatory framework and how devicemakers can comply. Source: The GMP…

The Federal Court of Australia has found Johnson & Johnson responsible in a lawsuit by more than 1,350 women over injuries linked to failures of its pelvic mesh. Source: The…

Health Canada is creating a stand-alone Medical Devices Directorate (MDD) within its Health Products and Food Branch that will take a “lifecycle approach” and also take on postmarket functions currently…

The FDA cited six device manufacturers for GMP and other violations found during agency inspections. Source: The GMP Letter

Sens. Chuck Grassley (R-Iowa), Elizabeth Warren (D-Okla.) and three representatives urged the Centers for Medicare & Medicaid Service to begin including information from unique device identifiers (UDIs) for high-risk implants…

The proposal by Australia’s Therapeutic Goods Administration to align its regulation of software as a medical device with the EU’s approach drew general support from stakeholders, with some also urging…

The FDA released draft guidance outlining the performance criteria sponsors of certain magnetic resonance coils should use to support substantial equivalence instead of a direct comparison. The guidance applies to…

The FDA sent a warning letter to American Contract Systems for process validation violations at its Houston, Texas medical device manufacturing and sterilizing facility. Source: The GMP Letter

A European Medicines Agency expert group has raised concerns about notified bodies assessing companion diagnostics. Source: The GMP Letter