Proposed FDA Guidance Would Provide Alternate Route For 510(k) Applications
US FDA has proposed new requirements for its abbreviated 510(k) program that could help certain sponsors get clearance for their products without having to compare to predicate devices.
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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.
Two 510(k) pilots from US FDA indicate the agency's desire for faster, easier clearances. But some observers aren’t sure if they’ll lead to real improvements.
The US regulatory agency has touted its newly proposed voluntary "expanded abbreviated" 510(k) program as a modern approach to regulation that will simplify the path for many. But industry groups are mostly scratching their heads.