USA's CMS and FDA consider overlapping premarket evaluations, as latter schedules biologics hearing

The US Food and Drug Administration and the Centers for Medicare and Medicaid Services (CMS) are considering establishing a process for overlapping evaluations of premarket, FDA-regulated medical products when the product sponsor and both agencies agree to such parallel review.

They say this process will serve the public interest by reducing the time between FDA marketing approval or clearance decisions and CMS national coverage determinations (NCDs). The agencies are establishing a docket to receive information and comment from the public on what products would be appropriate for parallel review by them, what procedures should be developed, how a parallel review process should be implemented, and other issues related to the effective operation of the process.

The agencies are also announcing their intent to create a pilot program for parallel review of medical devices. The pilot program will begin after both agencies have reviewed the public comments on this notice. A memorandum of understanding (MOU) concerning the exchange of data and information has been completed between the two agencies.