C
chunlin
medical devices apply FDA approved success rate?
Hello chunlin and welcome to the Cove
Is your question asking for what is the success rate for FDA to approve a new medical device application ?
C
chunlin
Hello chunlin and welcome to the Cove
Is your question asking for what is the success rate for FDA to approve a new medical device application ?
yes
what is the success rate for FDA to approve medical device application ?
yes
what is the success rate for FDA to approve medical device application ?
As per the GAO report,http://gao.gov/new.items/d09190.pdf
In fiscal years 2003 through 2007, as part of its premarket review to determine whether devices should be permitted to be marketed in the United States, FDA
• reviewed 13,199 submissions for class I and II devices via the 510(k) process, clearing 11,935 (90 percent) of these submissions;
• reviewed 342 submissions for class III devices through the 510(k) process, clearing 228 (67 percent) of these submissions; and
• reviewed 217 original and 784 supplemental PMA submissions for class III devices and approved 78 percent and 85 percent, respectively, of these submissions.
There is a latest report here - http://www.gao.gov/assets/590/588969.pdf
C
chunlin
thx, so much.
C
chunlin
have success rate for EU medical device approval?
