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Article: Long-awaited FDA DES draft guidance raises regulatory bar for 3.0 DES devices.(Food and Drug Administration, drug-eluting stents)
- Article from:
- Biomedical Business & Technology
- Article date:
- April 1, 2008
- Author:
CopyrightCOPYRIGHT 2008 AHC Media LLC. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Long-awaited FDA DES draft guidance raises regulatory bar for 3.0 DES devices
By DON LONG
BB&T Executive Editor
After more than two years of questions raised by clinical data concerning the safety and efficacy of drug-eluting stents (DES), steep declines in the sales of DES devices because of these questions, and DES developers looking for R&D and regulatory guidance, FDA in late March issued a new set of guidelines, in draft form, concerning the development, testing and manufacture of DES devices -- probably impacting the third generation and beyond of these devices.
In releasing the guidelines, the FDA acknowledged that it "and the ...