The FDA released a notice today announcing updated, withdrawn and modified standards that the agency will use in reviewing premarket applications for a variety of medical devices.
The standards can be used to support 510(k) applications by demonstrating "reasonable assurance of safety and/or effectiveness for many applicable aspects of medical devices."
Far from ditching the 510(k) program, as recommended by the Institute of Medicine’s recent report, the FDA newest updates to the consensus standards outline new standards and modify existing standards for applicants to base their submissions on.
Changes cover updated intraocular lens guidelines, modified endurance testing for total hip joint implants and new standards for fatigue-testing dental implants.
The FDA’s notice titled "Modifications to the List of Recognized Standards, Recognition List Number: 027," can be accessed via the agency’s site.