Device Firms Weigh Pros And Cons Of FDA-CMS Parallel Review

Article preview from "The Gray Sheet" - November 22, 2010

As FDA and CMS edge closer to a joint program for pre-market review and reimbursement decision-making, device and diagnostic firms are expressing wariness about participating.

Device Firms Weigh Pros And Cons Of FDA-CMS Parallel Review

Article preview from "The Gray Sheet" - November 22, 2010

As FDA and CMS edge closer to a joint program for pre-market review and reimbursement decision-making, device and diagnostic firms are expressing wariness about participating.

In September, the agencies announced their intent to explore the parallel review pathway through a pilot program for medical devices. (See " FDA And CMS Parallel Reviews Will Begin With Device Pilot Program " – "The Gray Sheet" Sept. 20, 2010.)

The agencies are still hashing out the details and accepting public comments on key questions through Dec. 16, after which they will begin vetting applicants to participate in the pilot.

But while FDA and CMS tout potential time and resource savings of parallel FDA and CMS reviews, some device firms remain unconvinced.

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