The U.S. Food and Drug Administration has issued new draft guidance that would exempt certain Class I and II medical devices from premarket submission requirements.
The FDA has identified certain Class II medical devices for which the regulatory agency believes a 510(k) review is not necessary to assure safety and effectiveness before these devices enter the marketplace, and certain Class I medical devices which it believes no longer meet the reserved criteria of the Federal Food, Drug, and Cosmetic Act .
These devices are sufficiently well understood and do not present risks that require premarket notification review to assure their safety and effectiveness, states the draft guidance. In addition, until the publication of a final rule or order exempting these devices from 510(k), the FDA states that it does not intend to enforce compliance with premarket submission requirements for these devices and does not expect manufacturers to submit 510(k)s for these devices during this time period.
This is big news and a huge boost to the mHealth industry, said Bradley Merrill Thompson, an attorney at Washington, D.C.-based law firm Epstein Becker Green who counsels medical device companies on FDA regulatory issues. It shows that FDA is being extremely practical in reviewing its own practices and updating its regulatory requirements where the risks simply do not merit the investment of regulatory resources. My hat is off to FDA.
The draft guidance is available here.
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