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The Use of Polyurethanes In Medical Device Applications

SpecialChem / Jun 26, 2007

Raw materials, including resins are not approved per se, by FDA. In fact, the great majority of medical devices entering the market today are never actually approved by FDA. Instead, manufacturers must notify the Center for Devices and Radiological Health (510(k) notification) of their own determination that their device is substantially equivalent to a type of medical device which has been on the market since 1976.Therefore, the manufacturer’s selection of a raw material or component part is based on its suitability for the intended use of the device, and its potential impact on a substantial equivalence determination. If substantial equivalence is not obtainable, then the device manufacturer must file a PMA (Pre Market Approval) on the new device. Even the raw materials and component parts of devices which are subject to premarket approval are not approved individually. FDA will evaluate the safety and effectiveness of a device for its intended use, and approvals are granted to the final product based on these considerations.

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