FDA Announces Parallel Review Indefinitely Extended - McDermott+Consulting

FDA Announces Parallel Review Indefinitely Extended

The Food & Drug Administration (FDA) together with the Centers for Medicare and Medicaid Services (CMS) have announced that medical device Parallel Review has been fully implemented and will be extended indefinitely.


The Parallel Review program was launched in 2010 and is a two-stage process designed to shorten wait time while seeking FDA approval and a CMS coverage decision for a new medical device. Stage 1: pivotal clinical trial design development stage; Stage 2: concurrent evidentiary review stage.

Manufacturers seeking parallel review should submit a request prior to the start of the first stage by emailing Parallel-Review@fda.hhs.gov.

FDA and CMS intend to review requests and respond within 30 days after receipt of the e-mail.

Additional information can be found in the Federal Register notice.