A
What do people think of the GAO report on the 510(k) process?
I am slightly disappointed. After all the promise and expectation that it would “shake-up” the 510(k) process, it has under-delivered. What happened to the rumours that it would lead to the creation of another Class, increased data requirements for 510(k) submissions, and increased evaluation time?
By focusing this report has been on Class III devices that are able to be cleared through the 510(k) process (rather than the PMA process), the GAO has taken the easy path. Instead of using this as an opportunity to challenge the status quo and consider alternatives, the report has focused on 1 colour from the bigger picture.
Medical Devices: FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process. GAO-09-190, January 15. http://www.gao.gov/cgi-bin/getrpt?GAO-09-190
I am slightly disappointed. After all the promise and expectation that it would “shake-up” the 510(k) process, it has under-delivered. What happened to the rumours that it would lead to the creation of another Class, increased data requirements for 510(k) submissions, and increased evaluation time?
By focusing this report has been on Class III devices that are able to be cleared through the 510(k) process (rather than the PMA process), the GAO has taken the easy path. Instead of using this as an opportunity to challenge the status quo and consider alternatives, the report has focused on 1 colour from the bigger picture.
Medical Devices: FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process. GAO-09-190, January 15. http://www.gao.gov/cgi-bin/getrpt?GAO-09-190