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FDA Launches Medical Device Innovation Initiative
Date:2/8/2011

mine their appropriateness for marketing.  

Because of the transformative nature of the devices that would be eligible for this pathway, CDRH expects them to generally be approval pathways intended for either high risk or novel products.

The FDA could conduct premarket reviews of products in the Innovation Pathway within 150 days, nearly half the time it currently takes the FDA to review most premarket approval applications.

CDRH has set up a public docket to solicit public comment on the Innovation Initiative and will host a public meeting on the topic on March 15, 2011 at the Center's White Oak campus.

For more information:

http://www.fda.gov/deviceinnovation

Consumer Inquiries: 888-INFO-FDA


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SOURCE U.S. Food and Drug Administration
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