The Institute of Medicine recently released a report finding that the Food and Drug Administration's 510(k) clearance process is flawed based on its legislative foundation, according to an IOM report.
The report suggests that the current process lacks the legal basis to support a reliable premarket screen of moderate-risk Class II devices. Under the current system, the 510(k) clearance relies on "substantial equivalence," or similarity to a previously approved comparable product, for approval. The IOM report says this system cannot assure the devices reaching the market now are safe and effective.
The report recommended the FDA focus its resources on developing an integrated premarket and postmarket regulatory framework that will provide reasonable assurance of safety and effectiveness of medical devices instead of continuing to modify the current process. The report also suggested the FDA explore a modified version of its de novo process, which could replace the 510(k) process. However, the de novo system would need to become less time-consuming and more easily navigable.
The report also found substantial weakness in the postmarket oversight of devices and it faces litigation on its authority to address problems associated with products already on the market. The report recommended Congress pass legislation to remove barriers to the FDA's use of postmarket regulatory authority if the agency fails to identify and correct its current weaknesses.
Read the release about the IOM report.
Related Articles on IOM:
IOM Completes Study of FDA 510(k) Process, Seeks Imput from Industry
Generalists Should Handle Most Pain Cases, Says IOM Report
AAOS: Review FDA 510(k) Program, Don't Switch to the PMA Process
The report recommended the FDA focus its resources on developing an integrated premarket and postmarket regulatory framework that will provide reasonable assurance of safety and effectiveness of medical devices instead of continuing to modify the current process. The report also suggested the FDA explore a modified version of its de novo process, which could replace the 510(k) process. However, the de novo system would need to become less time-consuming and more easily navigable.
The report also found substantial weakness in the postmarket oversight of devices and it faces litigation on its authority to address problems associated with products already on the market. The report recommended Congress pass legislation to remove barriers to the FDA's use of postmarket regulatory authority if the agency fails to identify and correct its current weaknesses.
Read the release about the IOM report.
Related Articles on IOM:
IOM Completes Study of FDA 510(k) Process, Seeks Imput from Industry
Generalists Should Handle Most Pain Cases, Says IOM Report
AAOS: Review FDA 510(k) Program, Don't Switch to the PMA Process