Performance Criteria Issued On Magnetic Resonance Coils In New FDA Draft Guidance
Through a draft guidance, the US agency has established performance criteria for magnetic resonance coils, making the devices eligible for the standards-based Safety and Performance Based Pathway.
You may also be interested in...
In a new final guidance, the US agency has expanded its abbreviated 510(k) program for certain devices to look beyond conformity assessments and instead look at performance criteria. Alongside the guidance, the agency also released four draft guidances for devices it is considering clearing under the new pathway.
Sleep apnea treatment company ResMed Corp. will pay $39.5m to settle allegations that it violated the False Claims Act by giving free or discounted goods and services to distributors and health-care providers to encourage the use of the firm’s devices.
Three patients have filed suit against Medtronic in recent weeks alleging they were injured by malfunctioning surgical staplers made by the company. The lawsuits add to recent scrutiny of the device type’s safety.