The program is a new pathway that will guide the user through constructing and submitting their 510(k) submissions electronically without having to submit a hard copy or a compact disc.
The FDA will be allowing any devices regulated by the CDRH’s Office of Device Evaluation ODE’s division of neurological and physical medicine devices, division of orthopedic devices or the division of surgical devices to participate in the program. It is intended to help make 510(k) submissions more compliant and less time-consuming, according to a report by the Regulatory Affairs Professional Society.
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