FDA Weighing Future of Third-Party Device Review http://ow.ly/1o28W
Faster Than The Speed Of Guidance: FDA Explores New Ways To Issue Updates
March 18, 2010 – Medical Device Today Article reprinted from “The Gray Sheet” – March 15, 2010 FDA is exploring ways to inform industry of changes to its regulatory expectations more quickly than guidance documents or standards development allow, device center
AAMI News: Online Med Dvc Stan…
AAMI News: Online Med Dvc Standards Portal Access to Over 2,000 Std’s & Reg’s (AAMI, ANSI, ASTM, DIN, IEC/ISO, FDA) http://ow.ly/1n2Jg
FDA Formally Recognize IEC 60601-1, 3rd ed.
The FDA is to Formally Recognize the Medical Electrical Safety Standard IEC 60601-1:2005, 3rd ed From AAMI March 12, 2010 press release The U.S. Food and Drug Administration (FDA) will formally recognize the electrical equipment standard IEC 60601-1/Ed.3:2006.
FDA 510(k) process Meeting of 2/18/10
FDA staff say agency may need new device powers Reuters on 2/18/10 wrote about the well attended meeting by industry representatives.