The FDA put out a list of alternative ways to comply with quality system requirements for device combination products, making suggestions for design controls and quality system regulation exemptions. Source:…
The FDA invited stakeholder comments on how it should craft rules governing medical device software under the 21st Century Cures Act. Source: The GMP Letter
India’s Drugs Controller General adopted essential principles for safety and performance of medical devices. Source: The GMP Letter
The FDA issued 483s to six device facilities for a variety of deficiencies including design control procedures, data integrity, CAPAs and complaint handling. Source: The GMP Letter
Australia’s Therapeutic Goods Administration released findings from a public consultation on proposed regulatory changes for personalized and 3D printed medical devices and said, based on the stakeholder feedback, it decided…
Health Canada is making further reductions in audit times for its Medical Device Single Audit Program for smaller companies with lower-risk products. Source: The GMP Letter
The FDA rejected a push to impose additional regulations on third-party servicers of medical devices, saying there is insufficient evidence to justify imposing new regulatory requirements. Source: The GMP Letter
FDA Commissioner Scott Gottlieb offered more perspective on new initiatives the agency is undertaking to improve medical device safety in remarks at the FDLI annual conference in Washington, D.C. Source:…
Australia’s Therapeutic Goods Administration plans to conduct a product safety review on ventilators used in high-care hospital settings for long-term therapy of intubated patients. Source: The GMP Letter
New Zealand’s Medicines and Medical Devices Safety Authority is proposing fee increases for the majority of its services, including reviewing new devices and GMP inspections. Source: The GMP Letter