Is Your Change Control Program Ready for FDA 510(k) Scrutiny?
A trio of FDA 510(k) guidances demonstrate how important it is for medical device manufacturers to get a firm grip on document management and change control – especially when working within the Third Party (TP) Review Program or trying to determine if a medical device change warrants a new 510(k). The agency is attempting to make it easier on device makers if they understand how to work within the new system.
FDA’s New 510(k) Guidance Emphasizes Software as Device Factor
The path to medical device commercialization requires FDA approval, which most often means filing a pre-marketing notification, also known as a 510(k). The FDA has specific criteria for accepting a 51 [...]
FDA 510(k) Approval Process Now Averages Over Six Months
If you’ve got six months – and nerves of steel – here’s some good news: You have a 61% percent chance of getting your medical device approved by the FDA. That’s one nugget of interesting data to be f [...]
