A medical device which “presents a potential unreasonable risk of illness or injury” that cannot be alleviated by alternate means such as proper labeling, prohibitions against adulteration, performance standards, or post-market surveillance falls within Class III under the Medical Device Amendments to the Food, Drug and Cosmetic Act, 21 U.S.C. § 301 et seq. See 21 U.S.C. § 360c(a)(1); 21 C.F.R. 860. Class III medical devices include pacemakers, artificial heart valves, and prosthetic hip joints.

All Class III devices are subject to premarket approval (PMA), a process by which the FDA evaluates a given device’s safety and efficacy using extensive data submitted by the manufacturer. Devices that clear the PMA process are shielded to some extent from potential liability by the MDA preemption clause, 21 U.S.C. §360k(a). In order to prevail on a claim that a device that has received premarket approval is defective, a claimant must in effect demonstrate that the device maker failed to comply with the conditions for the device’s manufacture and labeling established during the PMA process. See, e.g., Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).

Despite the lure of MDA preemption, many device makers choose to forego the PMA process when possible because of its time and expense. The PMA process is estimated to require an average of 1,200 hours of agency time for each device and a high multiple of that figure in manufacturer efforts. Medtronic, Inc. v. Lohr, 518 U.S. 470, 477 (1996).

The three widely understood exceptions to the PMA requirement for Class III medical devices are (1) the investigational device exception, 21 U.S.C. § 360j(g) (which allows use of the device only in a setting like clinical trial); (2) the predicate device exception, 21 U.S.C. § 360e(b)(1)(A) (which grandfathered medical devices on the market at the time of the MDA’s 1976 enactment); and (3) the 510k process exception, 21 U.S.C. § 360c(i)(1)(A) (under which a device may be approved for sale to the general public upon a showing that it is “substantially equivalent” to an approved device, with the same intended use and technical characteristics).

While a truly new device will have to undergo PMA, many devices for which approval is sought are refined iterations of predicate devices. What is not well understood is that the 510k process is not the exclusive path to market for these devices. A significant amount of litigation and attendant publicity has ensued over devices for which no 510k or other FDA approval was obtained before their use in patients. Indeed, “no prior approval by FDA” constitutes the gist of plaintiffs’ claims in cases of this type. See, e.g., Grotto and Shelton, Heart-Valve Rings Slip through FDA Loophole, Chi. Trib., May 22, 2011; Shelton and Grotto, Patients at Heart of Medical Device Issue, Chi. Trib., May 22, 2011. But claims that marketing these devices is “illegal” or gives rise to liability because contrary to FDA requirements are mistaken where the device at issue falls within the “justification to file” exception to 510k requirements.

A manufacturer must submit a 510k application for a Class III device based on an existing device only where the sum of incremental changes “could significantly affect the safety or effectiveness of the device.” 21 C.F.R. § 807.81(a)(3). (Alternately, the manufacturer may seek PMA approval.) Qualifying alterations include a significant change or modification in the device’s design, materials, chemical composition, energy source (in the case of a powered device like a pacemaker), or manufacturing process. Id.

Guidance issued by FDA has authorized manufacturers to carefully compare the device under consideration with a current, legally marketed predicate device in order to determine whether the conditions under which a 510k application is required are met. A manufacturer may test the device extensively as part of this evaluation. Manufacturers are required to document their analysis in writing, thereby justifying any determination that a given device is not required to undergo 510k approval. This “justification to file” procedure (sometimes referred to as “document to file”) authorizes the marketing of medical devices that embody evolutionary changes not requiring 510k (or PMA) approval. Given the prohibition against lawsuits premised on “fraud on the FDA” theories articulated in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), claims which seek to impose liability because a device that came to market through the “justification to file” route was not “approved by FDA” before use are tenuous at best.•

John P. Twohy is a member of the DTCI board of directors and is a partner in the Hammond office of Eichhorn & Eichhorn, LLP. The opinions expressed in this article are those of the author.