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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
Investigators found that the facility’s design validation procedures did not include a requirement to demonstrate equivalency to the production units. Read More