The Federal Food, Drug, and Cosmetic Act (FFDCA) requires a reasonable assurance of safety and effectiveness before a device can be marketed; It is responsible for enforcing this requirement. Devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the 510(k) process. Recently some policymakers and patients, as well as the medical-device industry, have asserted that the process has become too burdensome and time-consuming and that it is delaying important new medical devices from entering the market. FDA asked IOM to answer 2 questions: 1) Does the current 510(k) clearance process optimally protect patients and promote innovation in support of public health? 2) If not, what legislative, regulatory, or administrative changes are recommended to achieve optimally the goals of the 510(k) clearance process?
After all the reviews, IOM came up with 2 conclusions: 1) The 510(k) clearance process generally is not intended to evaluate the safety and effectiveness of medical devices because the standard for clearance is substantial equivalence to any previously cleared device 2) Information that would allow an understanding
of the extent to which the 510(k) clearance process either facilitates or inhibits innovation does not exist.
The Institute of Medicine concludes that the FDA should replace the 510k with a standard that provides reasonable assurance of safety and effectiveness.