A committee of the Institute of Medicine concludes that the Food and Drug Administration's 510(k) process for approving medical devices deemed to have a moderate risk to patients needs not to be reworked, but replaced.

IOM studied the 510(k) issue at the request of the FDA. The committee was asked to answer two questions:

* Does the current 510(k) process protect patients optimally and promote innovation in support of public health?

* If not, what legislative, regulatory or administrative changes are recommended to achieve the goals of the 510(k) process optimally?

The IOM committee in a new report concludes that the 510(k) process "lacks the legal basis to be a reliable premarket screen of the safety and effectiveness of moderate-risk devices and, furthermore, that it cannot be transformed into one."

Nor is the committee impressed with FDA's "postmarketing surveillance" program to monitor the safety and effectiveness of devices after they are approved, calling it inadequate and unfixable.

Further, the committee can't determine whether the 510(k) process over 35 years has had a positive or negative effect on device innovation.

Consequently, "The committee finds that the current 510(k) process is flawed based on its legislative foundation," IOM contends in a new report, Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. "Rather than continuing to modify the 35-year-old 510(k) process, the committee concludes that the FDA's finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle."

For more information, including a report brief, the committee's letter to FDA, and to purchase the full report, click here.

An FDA request for public comment, soon being published in the Federal Register, is here.


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