The FDA recently launched a new pilot program called Quality in 510(k) or Quik that allows manufacturers of moderate risk medical devices to use the eSubmitter software program to submit their 510(k) application to the FDA. There are approximately 40 product codes, all product that are well understood, that are eligible for the Quik program. Examples of the types of products that are included are electronic stethoscopes, surgical wire and ophthalmic cameras.
The project represents the efforts of FDA Commissioner Scott Gottlieb to modernize the agency and to advance progress in the medical device industry. According to Commissioner Gottlieb the review time for 510(k) submitted through the Quik program will be cut from 90 days to 60 days. By streamlining the process for low risk and moderate risk devices, the agency can therefore spend more resources on reviewing high risk medical devices.
The pilot program is scheduled to run for about a year and the agency will then assess the program and decide to continue it or even expand it.
To learn more about the Quik program please visit the FDA site here.
eSubmitter software downloads can be found here.