Fierce Medical Devices

July 13, 2012 | By Damian Garde

In keeping with its pledge to work with devicemakers to speed up the approval process, the FDA has released draft guidance on a prospective pre-submissions program, allowing companies to get early feedback before submitting devices for approval.

The proposed program would allow devicemakers to file a pre-sub before conducting clinical studies or before applying for approval, and the FDA hopes the program will reduce the regulatory hurdles companies face by looping in the agency before starting the PMA process. Furthermore, the FDA is offering to hold informal meetings with devicemakers before starting approval hearings…

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