Monday, April 20, 2009

FDA Scrutinizing "New" Medical Devices

Filed under: Business of Medicine , Public Health , Regulation

The Wall Street Journal is reporting that the Food and Drug Administration is requiring Johnson & Johnson, Medtronic, Inc., Royal Philips Electronics, and a various other medical device manufacturers to further explain and justify their products' safety and efficacy.

This is a part of the Safe Medicals Act of 1990, passed by Congress, that tightens control and testing of Class 3 devices. There is some concern that these new actions by the FDA will lead to further increases the cost of development of new medical equipment and lengthen the time to clinical use in patients.

While the bill was made into law in the 1990s, the FDA has had significant problems fully implementing all of the aspects of it, and this has allowed Class 3 devices to be put into use based on a previous statute. The FDA is reviewing all of these devices now, and calls on companies to test efficacy and safety under the "new" 1990 guidelines, or possibly seek reclassification of devices.

From the WSJ:

Mary Long, an agency spokeswoman, said it could take several years for the agency to finish the process. Manufacturers would be granted a grace period to submit enough evidence backing their devices under the more-rigorous standard. "It is a priority, but it will really depend on the kind and amount of information we get on each type," she said.

We support our patient safety above all else, but mention this FDA review because of the potential impact it may have to current and future medical device development.

WSJ : Medical Devices Face new Scrutiny from FDA

Library of Congress : Safe Medical Device Act of 1990 (H.R. 3095 and S. 3006)

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