AdvaMed Says Abbreviated 510(k) Guidance Needs More on Device Types

July 13, 2018

The FDA should clarify which device types will be eligible for its abbreviated 510(k) pathways, AdvaMed said in a written comment on the agency’s draft guidance.

AdvaMed said the pathway will depend on forthcoming FDA guidances specific to each device type and that the agency should provide more details about how it intends to prepare the guidances.

The draft guidance says source criteria will come from FDA staff, literature, and data from existing devices, but it makes no mention of input from healthcare professionals and other stakeholders.

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