Breakthrough Devices Will Get Priority Reviews Under CDRH Initiative

Article preview from "The Gray Sheet" - February 9, 2011

For a select few devices per year, FDA says it will speed up pre-market decision times by intensifying staff efforts, with a particular focus on very early-stage interactions with product sponsors.

Breakthrough Devices Will Get Priority Reviews Under CDRH Initiative

Article preview from "The Gray Sheet" - February 9, 2011

For a select few devices per year, FDA says it will speed up pre-market decision times by intensifying staff efforts, with a particular focus on very early-stage interactions with product sponsors.

The new priority review program, termed the "innovation pathway," is the core component of an initiative announced yesterday by CDRH to reduce the costs and time required for development of groundbreaking technologies.

It appears to closely parallel a proposal that has been circulated by the National Venture Capital Association to create a new review path for novel devices. (See "¹ VC Firms Seek New FDA Review Path, User Fee For 'Novel' Devices" - "The Gray Sheet" June 28, 2010.)

More generally, the CDRH initiative is intended to align with an increased focus both inside and outside of government on improving the global competitiveness of U.S. industry. (See "² Device Innovation: Report Paints Dire Picture; Prez, FDA Take 'Positive' Steps" - "The Gray Sheet" Jan. 24, 2010.)

 

To purchase this article online or get it FREE when you subscribe to "The Gray Sheet".

Plus:

To find out about more about more about Elsevier Business Intelligence's medical device publications and databases, multi-user access and/or advertising with Medical Devices Today, please contact Kristy Kennedy at (480) 985-9512