FDA Finalizes First Two Guidances For 510(k) Pathway That Uses Performance Measurements
The guidances outline testing and performance criteria for Foley catheters and cutaneous electrodes submissions through the new abbreviated 510(k) pathway.
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Device center officials at the US agency focused on new approval pathways at RAPS Convergence 2020.
The 13-page guidance document lays out what the agency looks for in deciding which consensus standards it can rely upon for premarket submissions.
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.