FDA proposes exempting certain devices from premarket requirements

The U.S. Food and Drug Administration has issued draft guidance that would exempt certain medical devices from premarket submission requirements.

The proposed guidance indicates certain Class I and Class II medical devices that "are sufficiently well-understood and do not present risks that require premarket notification (510(k)) review to assure their safety and effectiveness," according to the document.

The draft guidance identifies certain classified devices from a range of specialties, including anesthesiology, cardiology, dental, gastroenterology and urology. The identified devices are deemed low risk, therefore not requiring all the premarket submission requirements, according to the report.

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