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All new biomaterials require proof that they are effective and safe before they can be approved for marketing. In the United States, the process for approval follows strict guidelines and regulations set out by the United States Food & Drug Administration (FDA).Biomaterials are expected to be approved as medical devices according to a 510k, or pre-market approval (PMA) paths. Highlights of that approval process are explained here.For complete information about the biomaterials development process, see the FDAs Center for Devices and Radiological Health (CDRH).

Medical Devices
At the FDA, medical devices are classified as Class I, II, and III. Regulatory control increases from Class I to Class III. The device classification defines the regulatory requirements for a general device type. Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k); most Class III devices require PMA.

A 510(k) is a premarket notification made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to PMA. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. PMA is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s). An approved PMA is, in effect, a private license granting the applicant (or owner) permission to market the device. FDA regulations provide 180 days to review the PMA and make a determination.

Read Expert Advice on the FDA to learn more about the approvals for medical devices.

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