It’s Raining Guidance Docs: FDA Expands Abbreviated 510(k) Program
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.
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The guidances outline testing and performance criteria for Foley catheters and cutaneous electrodes submissions through the new abbreviated 510(k) pathway.
Through a draft guidance, the US agency has established performance criteria for magnetic resonance coils, making the devices eligible for the standards-based Safety and Performance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.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-five guidance documents have been posted on the tracker since its last update.