FDA, CMS Parallel Review Program To Be Made Permanent

The FDA and the Centers for Medicare & Medicaid Services are transitioning their pilot program for parallel review of medical devices to a permanent program and are asking manufacturers to submit applications.

The agencies learned two primary lessons from the pilot program.

They found that manufacturers benefit from receiving feedback from both agencies at the pivotal clinical trial design phase. This can assist manufacturers in designing pivotal trials that can answer both agencies’ evidentiary questions. — Jeff Kinney