USA – FDA posts final guidance on device-specific performance criteria

FDA has released three device-specific guidance documents detailing performance criteria in support of its Safety and Performance Based Pathway. The texts cover magnetic resonance (MR) receive-only coils, spinal plating systems and non-spinal metallic bone screws.
 
Last year, FDA published guidance on the optional Safety and Performance Based Pathway. The text set out the agency’s thinking on a pathway intended to enable companies to show a new product is as safe and effective as a legally marketed device using FDA-identified performance criteria.
 
FDA went on to release draft guidance documents on the specific criteria for spinal plating systems, non-spinal metallic bone screws and two other device types later in 2019. Draft guidance on MR coils followed before the end of the year…