The FDA issued a warning letter to a devicemaker in Pest, Hungary for serious quality system failures, including inadequate design and process controls. Source: The GMP Letter

The European Commission has adopted a proposal to delay implementation of the EU Medical Device Regulation (MDR) for a year due to the COVID-19 pandemic. Source: The GMP Letter

The International Medical Device Regulators Forum (IMDRF) released final guidance on harmonized regulations for adverse event reporting, cybersecurity, and personalized medical devices. Source: The GMP Letter

The FDA issued a final rule banning electrical stimulation devices (ESDs) used to reduce aggressive or self-harming behavior, saying that better treatment options are now available. Source: The GMP Letter

Under a settlement with the Federal Trade Commission, devicemaker NeuroMetrix agreed to pay at least $4 million and stop making deceptive claims that its Quell transcutaneous electrical nerve stimulation device…

Six devicemakers drew the FDA’s attention for lax validations, CAPAs, training and other failures found during agency inspections. Source: The GMP Letter

The FDA issued warning to four devicemakers for lax design controls, inaccurate labeling and other serious failures at their manufacturing facilities. Source: The GMP Letter

The FDA announced in a new guidance that it does not plan to object to delays in adverse event reporting for medical products during the pandemic. Source: The GMP Letter

HHS is providing immunity from legal liability for activities related to medical countermeasures against COVID-19. Source: The GMP Letter

The European Commission has authorized the National Standards Authority of Ireland (NSAI) as the 11th notified body under the EU’s Medical Device Regulation. Source: The GMP Letter