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The draft guidance identifies certain classified devices from a range of specialties, including anesthesiology, cardiology, dental, gastroenterology and urology.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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