United States: FDA Off-Label Promotion Memo Should Affect §510k Preemption & Evidence

Last Updated: February 6 2017
Article by James Beck

Remember how Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), dismissed the §510k "substantially equivalence" medical device clearance as non-preemptive because it was supposedly "focused on equivalence, not safety"? Id. at 493. In the same vein:

"[S]ubstantial equivalence determinations provide little protection to the public. These determinations simply compare a post − 1976 device to a pre − 1976 device to ascertain whether the later device is no more dangerous and no less effective than the earlier device. If the earlier device poses a severe risk or is ineffective, then the later device may also be risky or ineffective."

Id. (quoting from pro-plaintiff law review article).

Most of our readers know that this characterization, assuming it was true for the 1980s-era (implanted 1987) device that the Court considered in Lohr, was no longer true, even at the time Lohr was decided, and certainly hasn't been the case since the FDAAA was passed a year after Lohr was decided. Still, this anachronistic view of §510k has flourished for twenty years, affecting first preemption and now (thanks mostly to Mesh MDL rulings) admissibility of evidence.

That's why we were interested in what the FDA had to say about today's §510k clearance process in its recent memorandum entitled "Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products," which is available here. One of our guest bloggers, Liz Minerd, recently discussed the First Amendment aspects of that document, here.

However, Appendix A to that memorandum contains the FDA's current view of the nature of §510k clearance, and we think it could come in handy with respect to debunking the out-of-date discussion in Lohr. (Note: Lohr is also impaired in that it relied heavily, 518 U.S. 485, 494, on the presumption against preemption, which as we discussed here, has since been abolished in express preemption situations such as this). Here's what – according to the FDA, and not some pro-plaintiff commentator – §510k clearance is all about in 2017:

The type of premarket review pathway is determined by the degree of review and regulation that FDA deems necessary to provide a reasonable assurance of safety and effectiveness for a given device type. Although the premarket submission review pathways (e.g., approval application (PMA), de novo, and 510(k)) differ in various ways, they all fit within the same regulatory framework that enables FDA to ensure that devices on the market are ones that have been determined by FDA to have a reasonable assurance of safety and effectiveness for each and every use for which they are intended.

Memorandum at 40 (emphasis added). In particular, since 1990, "Congress . . . required FDA to evaluate whether a new device is as safe and effective as a predicate device." Id. at at 44 n.137 (discussing Safe Medical Devices Act of 1990) (emphasis added).

In clearing devices under §510k, the FDA does not distinguish between device classifications (I, II, or III) with respect to devices being safe and effective – all devices must be, regardless of classification:

Classification determinations must be based on an evaluation of the safety and effectiveness of the device considering (1) the persons for whose use the device is intended; (2) the intended conditions of use prescribed, recommended, or suggested in the labeling of the device; and (3) the probable benefits of the device as compared with the probable risks of its use.

Id. at 41 (footnote omitted) (emphasis added). In particular, "Class II devices are devices for which general controls, by themselves, are insufficient to provide reasonable assurance of the safety and effectiveness of the device, and for which there is sufficient information to establish special controls necessary to provide such assurance." Id. at 41 n.122 (citation omitted) (emphasis added). Thus, clearance of Class II devices is, contrary to Lohr's anachronistic statements, governed by "safety and effectiveness" criteria.

Specifically, as to §510k, while the "standard is comparative," review is intended to assure device safety and effectiveness:

The 510(k) review standard is comparative, whereas the PMA and de novo review standards rely on an independent demonstration of safety and effectiveness. Nonetheless, the principles of safety and effectiveness underlie the substantial equivalence determination in every 510(k) review.

Memorandum at 42-43 (emphasis added). We repeat: "every 510k review" is conducted in accordance with with "principles of safety and effectiveness." That's the FDA speaking in 2017.

During the 510(k) review, FDA considers the device's safety and effectiveness in its substantial equivalence determination (as discussed more fully below), and also in its evaluation of compliance with any applicable special controls, which FDA has determined to be necessary to provide a reasonable assurance of safety and effectiveness for the device type.

Id. at 43 (emphasis added).

Although the 510(k) process involves a comparison of a new device to a predicate device rather than an independent demonstration of the new device's safety and effectiveness . . ., in all these cases FDA's review process reflects a determination of the level of control necessary to provide a "reasonable assurance of safety and effectiveness."

Id. at 44-45 (emphasis added).

Indeed, the FDA explains how "safety and effectiveness" are addressed in two ways during the §510k clearance process. "First, FDA must find that the intended use of the device and its predicate are "the same." Id. at 44. "Second, when comparing a new device to a predicate device, FDA must find that the two devices have the same technological characteristics," or that any "change" "does not raise different questions of safety and effectiveness." Id. at 45. As to the first stage:

FDA determines the indications for use of the new device based upon review of the proposed labeling, and then may rely upon relevant clinical or scientific information that does not appear in the proposed labeling submitted with the 510(k) regarding the safety and effectiveness of the new indications for use.

Id. at 44-45 (footnote omitted) (emphasis added). This "information" may include "clinical data" of many types that constitutes "valid scientific evidence." Id. at 45 (listing types of acceptable studies). As to the second stage:

When evaluating whether a new device is as safe and effective as a predicate device, if the risks associated with the new device increase as compared to the predicate device . . ., FDA may still determine that the new device is substantially equivalent to the predicate device if . . . there are also increased benefits with the new device as compared to the predicate device. When looking at the increased risks posed by the new device, FDA may consider the degree of risk in comparison to the predicate device. FDA may also consider whether additional measures may help mitigate the increased risks.

Id. at 45 (footnotes omitted) (emphasis added).

Thus, as the FDA's current description of the §510k process demonstrates, a lot of attention is paid to "safety and effectiveness" during the course of this type of product evaluation. Whether or not the United States Supreme Court was wrong in Lohr's description of the §510k process applicable to a 1987 device, its characterizations are demonstrably in error if asserted against the currently applicable §510k process described by the FDA earlier this month. The FDA's regulatory world has not been static over the past quarter century. Likewise, where court precedent has been superseded by events, it needs to change to reflect current realities.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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James Beck
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