FDA to Exempt Certain Medical Devices from Premarket Rules

The Association for the Advancement of Medical Instrumentation (AAMI) is reporting that the Food and Drug Administration (FDA) has proposed removing more than 100 medical devices from premarket notification requirements, concluding the products are understood well enough that their safety and effectiveness are not in question.

The move has significant implications for the makers of such devices because the exemption makes it a lot easier for companies to introduce these products into the market.

The devices are varied, covering categories that include cardiovascular, dental, gastroenterological, neurological, surgical, ophthalmic, and ear, nose and throat.  The devices on the list released by the FDA are either unclassified or classified as Class I and Class II, low and moderate risk respectively.

In its announcement about its plan, the agency said it was committed to identifying those medical devices whose risks were low enough that they could fall outside the premarket notification process, commonly referred to as 510(k). The devices on the list, the FDA concluded, are “sufficiently well understood.”

The FDA has taken a number of steps in recent years that it says improve the regulatory review process. The agency has been under pressure to do so from manufacturers who say the review process has been needlessly burdensome and confusing, stymieing innovation and delaying the delivery of products to patients. Earlier this month, the FDA released a report about its medical device program, calling it “markedly improved.”

The FDA’s guidance document about the proposed exemptions is available HERE.

Source: AAMI

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