A Question For Parallel Review Planners: When CMS Should Get Involved

Article preview from "The Gray Sheet" - December 20, 2010

As FDA and CMS officials develop steps for parallel medical product reviews, a key question is when CMS should be brought into the pre-market process.

A Question For Parallel Review Planners: When CMS Should Get Involved

Article preview from "The Gray Sheet" - December 20, 2010

As FDA and CMS officials develop steps for parallel medical product reviews, a key question is when CMS should be brought into the pre-market process.

“When do we bring in CMS? Do we engage CMS initially when we have a device where the manufacturer has indicated an interest in parallel review and [if] we think it is an appropriate candidate? Also, when does CMS begin its analysis for a preliminary national coverage determination recommendation?” asked Nancy Stade, deputy director for policy at FDA’s Center for Devices & Radiological Health.

“Those are two of the big questions we still have that we are going to need to sort through.”

Stade and two CMS regulators talked about their ongoing work to develop a parallel review process during a Dec. 10 session at the Elsevier-sponsored FDA/CMS Summit for Biopharma Executives in Washington, D.C.

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