Walking Down the Innovation Pathway With the FDA


In February 2011, the Food and Drug Administration (FDA) and its Center for Devices and Radiological Health (Center) announced the Medical Device Innovation Initiative (Innovation Initiative), which will allow companies to achieve regulatory approval of ground-breaking medical devices quicker than ever before. See CDRH Innovation Initiative, U.S. Food and Drug Administration, Center for Devices and Radiological Health (Feb. 2011), available at the FDA website.

The United States is currently the world leader in developing medical devices. Bringing a cutting-edge medical device to market, however, is a time-consuming process. Currently, the majority of medical devices are approved under one of two processes: the premarket approval (PMA) process or the 510(k) process. An applicant seeking approval through the PMA process must demonstrate to the FDA a "reasonable assurance that the device is both safe . . . [and] effective." 21 U.S.C. § 360e(d)(2)(A). Upon a demonstration that the device is safe and effective, the FDA issues an order that allows the manufacturer to market the device as approved. See Davenport v. Medtronic, 302 F.Supp.2d 419, 426 (E.D. Pa. 2004). However, a device that is determined by the FDA to be the substantial equivalent of a "predicate device" may be marketed under a "510(k) notification" without further clinical study or the premarket approval that is required by the PMA process. 21 U.S.C. § 355(b)(1)(F). See also In re Orthopedic Bone Screw Prods. Liab. Litig., 1998 WL 964498 at *1 (E.D. Pa. Nov. 3, 1998).

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