The U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) are considering a process for overlapping evaluations of premarket, FDA-regulated medical products when the product sponsor and both agencies agree to a parallel review.
The proposed process is designed to reduce the time between FDA marketing approval or clearance decisions and CMS national coverage determinations.
The two agencies currently are establishing a docket to receive information and comment from the public on which products would be most appropriate for parallel review, what procedures should be developed, how a parallel review process should be implemented, and other issues related to the effective operation of the process. Public feedback will be accepted until December 16.
The FDA and CMS also want to create a pilot program for parallel review of medical devices. The initiative would begin after both agencies have reviewed the public comments on this notice.
Details are published in the September 17 issue of the Federal Register.
Related Reading
FDA targets improvements to 510(k) process, August 4, 2010
FDA changes PMA advisory panel process, April 27, 2010
FDA launches transparency Web site, April 20, 2010
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