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The FDA released version 0.2 of its Developing Software Precertification Program intended to allow the agency to more efficiently approve software as a medical device (SaMD) without risking patient health and safety. Read More
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. Read More
The FDA issued 483s to six device facilities for a variety of deficiencies including design control procedures, data integrity, CAPAs and complaint handling. Read More
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 not to implement regulatory changes for the devices at this time. Read More
Health Canada is making further reductions in audit times for its Medical Device Single Audit Program for smaller companies with lower-risk products. Read More
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. Read More
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. Read More
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. Read More
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. Read More
The FDA recommended factors to consider and precautions to take for premarket submissions of multiple function device products, noting there is no all-encompassing approach for the wide variety of multiple function devices. Read More