In what the Food and Drug Administration (FDA) referred to as a “first-of-a-kind guidance,” the FDA released its “Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications.”
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 process (PMA) 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). As part of this decision, the FDA reviews the data submitted with the device to assure that it demonstrates that the probable benefits of the device outweigh its probable risks. 21 C.F.R. 860.7. 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).
The de novo approval process is similar to the PMA process but involves low to moderate risk devices that may not need to confer as substantial a benefit to patients in order to have a favorable benefit-risk profile. Finally, 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).
The process discussed in the FDA’s guidance is primarily applicable to devices approved through the PMA and de novo approval processes. The intent behind the guidance is to provide industry insiders with an explanation of the principal factors the FDA considers when making benefit-risk determinations during the premarket review of certain medical devices, making the approval process predictable, consistent and transparent. The guidance also includes a worksheet for device reviewers that incorporates the principal factors that influence the benefit-risk determination. Beginning May 1, 2012, the FDA reviewers began to use this guidance document in the review of all PMA and de novo applications.
A copy of the Guide Document is available here.