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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. Oh, the name calling was not name calling, it was merely social commentary making this point, which is on the minds of many, as an aside to the article's focus: https://answers.yahoo.com/question/index?qid=20100111082327AAmlmMa Or, if you prefer a local angle, I give you exhibit A in that analysis of viva la difference: http://fox59.com/2015/03/16/moed-appears-on-house-floor-says-hes-not-resigning/

  2. Too many attorneys take their position as a license to intimidate and threaten non attorneys in person and by mail. Did find it ironic that a reader moved to comment twice on this article could not complete a paragraph without resorting to insulting name calling (rethuglican) as a substitute for reasoned discussion. Some people will never get the point this action should have made.

  3. People have heard of Magna Carta, and not the Provisions of Oxford & Westminster. Not that anybody really cares. Today, it might be considered ethnic or racial bias to talk about the "Anglo Saxon common law." I don't even see the word English in the blurb above. Anyhow speaking of Edward I-- he was famously intolerant of diversity himself viz the Edict of Expulsion 1290. So all he did too like making parliament a permanent institution-- that all must be discredited. 100 years from now such commemorations will be in the dustbin of history.

  4. Oops, I meant discipline, not disciple. Interesting that those words share such a close relationship. We attorneys are to be disciples of the law, being disciplined to serve the law and its source, the constitutions. Do that, and the goals of Magna Carta are advanced. Do that not and Magna Carta is usurped. Do that not and you should be disciplined. Do that and you should be counted a good disciple. My experiences, once again, do not reveal a process that is adhering to the due process ideals of Magna Carta. Just the opposite, in fact. Braveheart's dying rebel (for a great cause) yell comes to mind.

  5. It is not a sign of the times that many Ind licensed attorneys (I am not) would fear writing what I wrote below, even if they had experiences to back it up. Let's take a minute to thank God for the brave Baron's who risked death by torture to tell the government that it was in the wrong. Today is a career ruination that whistleblowers risk. That is often brought on by denial of licenses or disciple for those who dare speak truth to power. Magna Carta says truth rules power, power too often claims that truth matters not, only Power. Fight such power for the good of our constitutional republics. If we lose them we have only bureaucratic tyranny to pass onto our children. Government attorneys, of all lawyers, should best realize this and work to see our patrimony preserved. I am now a government attorney (once again) in Kansas, and respecting the rule of law is my passion, first and foremost.

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