The FDA today published a list of Class I and Class II medical devices that it now considers exempt from premarket notification, in accordance with the 21st Century Cures Act.

Sponsors of these devices will no longer have to apply for 510(k) clearance from the FDA. The agency said this action, published today in the Federal Register, decreases the regulatory burden on the medtech industry and eliminates private costs and expenditures required to comply with certain federal regulations.

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