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DTCI: 'Justification to file' on medical device review

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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.
 

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  1. I grew up on a farm and live in the county and it's interesting that the big industrial farmers like Jeff Shoaf don't live next to their industrial operations...

  2. So that none are misinformed by my posting wihtout a non de plume here, please allow me to state that I am NOT an Indiana licensed attorney, although I am an Indiana resident approved to practice law and represent clients in Indiana's fed court of Nth Dist and before the 7th circuit. I remain licensed in KS, since 1996, no discipline. This must be clarified since the IN court records will reveal that I did sit for and pass the Indiana bar last February. Yet be not confused by the fact that I was so allowed to be tested .... I am not, to be clear in the service of my duty to be absolutely candid about this, I AM NOT a member of the Indiana bar, and might never be so licensed given my unrepented from errors of thought documented in this opinion, at fn2, which likely supports Mr Smith's initial post in this thread: http://caselaw.findlaw.com/us-7th-circuit/1592921.html

  3. When I served the State of Kansas as Deputy AG over Consumer Protection & Antitrust for four years, supervising 20 special agents and assistant attorneys general (back before the IBLE denied me the right to practice law in Indiana for not having the right stuff and pretty much crushed my legal career) we had a saying around the office: Resist the lure of the ring!!! It was a take off on Tolkiem, the idea that absolute power (I signed investigative subpoenas as a judge would in many other contexts, no need to show probable cause)could corrupt absolutely. We feared that we would overreach constitutional limits if not reminded, over and over, to be mindful to not do so. Our approach in so challenging one another was Madisonian, as the following quotes from the Father of our Constitution reveal: The essence of Government is power; and power, lodged as it must be in human hands, will ever be liable to abuse. We are right to take alarm at the first experiment upon our liberties. I believe there are more instances of the abridgement of freedom of the people by gradual and silent encroachments by those in power than by violent and sudden usurpations. Liberty may be endangered by the abuse of liberty, but also by the abuse of power. All men having power ought to be mistrusted. -- James Madison, Federalist Papers and other sources: http://www.constitution.org/jm/jm_quotes.htm RESIST THE LURE OF THE RING ALL YE WITH POLITICAL OR JUDICIAL POWER!

  4. My dear Mr Smith, I respect your opinions and much enjoy your posts here. We do differ on our view of the benefits and viability of the American Experiment in Ordered Liberty. While I do agree that it could be better, and that your points in criticism are well taken, Utopia does indeed mean nowhere. I think Madison, Jefferson, Adams and company got it about as good as it gets in a fallen post-Enlightenment social order. That said, a constitution only protects the citizens if it is followed. We currently have a bevy of public officials and judicial agents who believe that their subjectivism, their personal ideology, their elitist fears and concerns and cause celebs trump the constitutions of our forefathers. This is most troubling. More to follow in the next post on that subject.

  5. Yep I am not Bryan Brown. Bryan you appear to be a bigger believer in the Constitution than I am. Were I still a big believer then I might be using my real name like you. Personally, I am no longer a fan of secularism. I favor the confessional state. In religious mattes, it seems to me that social diversity is chaos and conflict, while uniformity is order and peace.... secularism has been imposed by America on other nations now by force and that has not exactly worked out very well.... I think the American historical experiment with disestablishmentarianism is withering on the vine before our eyes..... Since I do not know if that is OK for an officially licensed lawyer to say, I keep the nom de plume.

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