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Concerns About Expanded 510(k)

AdvaMed says that if properly defined and implemented, a proposed new 510(k) expanded pathway “potentially complements the current 510(k) pathways, all of which assure that patients have timely access to safe, effective, and high-quality medical devices.” The trade group expresses a concern that an expanded abbreviated 510(k) depends on guidance documents written by FDA for each device type, defining the performance criteria for each device type. “The draft guidance states that source criteria will come from FDA staff, information in literature, and analysis of data for existing devices,” AdvaMed says. “Absent from the list is input from healthcare professionals and other relevant stakeholders.”

The Medical Imaging and Technology Alliance says it is unclear what benefit will come from an expanded pathway. “A clearly stated reduction in review time would be helpful,” it says. The association also notes that an issue in the program will be the clinical and scientific evidentiary standards for validation of equivalent analytical and clinical performance despite the lack of direct comparisons with the predicate device.

The American Medical Association tells FDA that it supports the scope of devices that will be eligible for the expanded pathway, the process for identifying performance criteria, and the provisions made for review of data including the agency’s ability to review upon request the underlying data demonstrating the performance criteria, where necessary.

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