United States

In the USA medical devices are regulated by the Center of Devices and Radiological Health (CDRH) a component within the FDA. Based on the level of regulatory control required for a respective device it will be classified into class I, II, or III.

In the US two regulatory pathways for medical devices exist: 1) The so called “510(k) process” based on the demonstration of substantial equivalence. For this process the manufacturer will need to show in a premarket submission to the FDA that the new device is as safe and efficient as a legally marketed device. FDA then “clears” the device for commercial distribution within the US by issuing an order stating that the device is substantially equivalent. Far over 90% of the medical devices marketed in the US are marketed based on a 510(k) clearance. 2) Class III medical devices are regulated via the Premarket Approval (PMA) process. PMA is the most stringent regulatory pathways for medical devices. The applicant must receive explicit FDA approval of its PMA application prior to marketing the device. Before approving a PMA application FDA will assess whether there is sufficient scientific evidence on the products safety and effectiveness for its intended use(s).

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