Premarket Notification “Not Substantially Equivalent” Rates Trending Upward
The rate of 510(k)s found "not substantially equivalent" has been rising over the last four fiscal years, an FDL-1Office of Device Evaluation annual report suggests
The rate of 510(k)s found "not substantially equivalent" has been rising over the last four fiscal years, an FDL-1Office of Device Evaluation annual report suggests