Tag Archives: Premarket Approval

Busy Week for FDA’s Center for Devices and Radiological Health

This post was written by Jillian W. Riley. Earlier this week, FDA’s Center for Devices and Radiological Health (CDRH) published two separate draft guidance documents to advance the dual goals of FDA and industry to provide pathways for medical devices to reach the market quickly while ensuring the safety and efficacy of the product. The … Continue Reading

FDA Issues Draft Guidance Regarding Acceptance & Filing Review for PMA Applications

This post was written by Erin Janssen. FDA has announced the release of a draft guidance document concerning the necessary elements and contents of a complete premarket approval (PMA) application and the key decisions that are made during the filing process. The draft guidance applies to all devices reviewed in a PMA application and, if … Continue Reading

CMS and FDA Publish Parallel Review Pilot Program Notice

On October 7, 2011, the Centers for Medicare & Medicaid Services and the Food and Drug Administration announced they are soliciting nominations from sponsors of medical devices to participate in a parallel review pilot program. The Agencies officially published a Federal Register notice announcing the program October 11, 2011 (the “Notice”), with an effective date of … Continue Reading