DTCI: 'Justification to file' on medical device review

Back to TopCommentsE-mailPrintBookmark and Share

TwohyA 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.


Post a comment to this story

We reserve the right to remove any post that we feel is obscene, profane, vulgar, racist, sexually explicit, abusive, or hateful.
You are legally responsible for what you post and your anonymity is not guaranteed.
Posts that insult, defame, threaten, harass or abuse other readers or people mentioned in Indiana Lawyer editorial content are also subject to removal. Please respect the privacy of individuals and refrain from posting personal information.
No solicitations, spamming or advertisements are allowed. Readers may post links to other informational websites that are relevant to the topic at hand, but please do not link to objectionable material.
We may remove messages that are unrelated to the topic, encourage illegal activity, use all capital letters or are unreadable.

Messages that are flagged by readers as objectionable will be reviewed and may or may not be removed. Please do not flag a post simply because you disagree with it.

Sponsored by
Subscribe to Indiana Lawyer
  1. We do not have 10% of our population (which would mean about 32 million) incarcerated. It's closer to 2%.

  2. If a class action suit or other manner of retribution is possible, count me in. I have email and voicemail from the man. He colluded with opposing counsel, I am certain. My case was damaged so severely it nearly lost me everything and I am still paying dearly.

  3. There's probably a lot of blame that can be cast around for Indiana Tech's abysmal bar passage rate this last February. The folks who decided that Indiana, a state with roughly 16,000 to 18,000 attorneys, needs a fifth law school need to question the motives that drove their support of this project. Others, who have been "strong supporters" of the law school, should likewise ask themselves why they believe this institution should be supported. Is it because it fills some real need in the state? Or is it, instead, nothing more than a resume builder for those who teach there part-time? And others who make excuses for the students' poor performance, especially those who offer nothing more than conspiracy theories to back up their claims--who are they helping? What evidence do they have to support their posturing? Ultimately, though, like most everything in life, whether one succeeds or fails is entirely within one's own hands. At least one student from Indiana Tech proved this when he/she took and passed the February bar. A second Indiana Tech student proved this when they took the bar in another state and passed. As for the remaining 9 who took the bar and didn't pass (apparently, one of the students successfully appealed his/her original score), it's now up to them (and nobody else) to ensure that they pass on their second attempt. These folks should feel no shame; many currently successful practicing attorneys failed the bar exam on their first try. These same attorneys picked themselves up, dusted themselves off, and got back to the rigorous study needed to ensure they would pass on their second go 'round. This is what the Indiana Tech students who didn't pass the first time need to do. Of course, none of this answers such questions as whether Indiana Tech should be accredited by the ABA, whether the school should keep its doors open, or, most importantly, whether it should have even opened its doors in the first place. Those who promoted the idea of a fifth law school in Indiana need to do a lot of soul-searching regarding their decisions. These same people should never be allowed, again, to have a say about the future of legal education in this state or anywhere else. Indiana already has four law schools. That's probably one more than it really needs. But it's more than enough.

  4. This man Steve Hubbard goes on any online post or forum he can find and tries to push his company. He said court reporters would be obsolete a few years ago, yet here we are. How does he have time to search out every single post about court reporters and even spy in private court reporting forums if his company is so successful???? Dude, get a life. And back to what this post was about, I agree that some national firms cause a huge problem.

  5. rensselaer imdiana is doing same thing to children from the judge to attorney and dfs staff they need to be investigated as well