Join our mailing list!

Official PayPal Seal

(Your shopping cart is empty)

  Home > Diane Publishing Books >

Medical Devices: FDA Should Take Steps to Ensure That High-Risk Device Types are Approved through the Most Stringent Premarket Review Process
Medical Devices: FDA Should Take Steps to Ensure T

Our Price: $30.00
By Marcia Crosse (au)
Year: 2009
Pages: 64
Binding Paperback

Product Code: 1437913059

The FDA is responsible for oversight of medical devices sold in the U.S. Regulations place devices into 3 classes, with class III including those with the greatest risk to patients. New devices must clear FDA premarket review via either the 510(k) premarket notification process, which determines if a new device is substantially equivalent to another legally marketed device, or the more stringent premarket approval (PMA) process, which requires the manufacturer to supply evidence providing reasonable assurance that the device is safe and effective. This report examined which premarket review process -- 510(k) or PMA -- FDA used to review selected types of device submissions in FY 2003 through FY 2007. Includes recommendations. Illus.

Share your knowledge of this product with other customers... Be the first to write a review
Diane Publishing Co
PO Box 617
Darby, PA 19023-0617
 About Us
 Become an Affiliate
 Privacy Policy
 Send Us Feedback
Company Info | Advertising | Product Index | Category Index | Help | Terms of Use
Copyright � 2004 Diane Publishing Company. All Rights Reserved.
Built with Volusion