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The FDA has taken recent steps that may, or may not, affect product liability litigation.  We’re discussing the “may” aspect.  For purely regulatory analysis, plenty of other commentary is available.

These actions occurred on September 7, 2023, and involve three “draft guidances” bearing on the “§510(k)” substantial equivalence clearance process for medical devices.  Any litigator with even passing knowledge of medical device preemption knows that this − more properly, a prior (1982) version − is the process that the Supreme Court stated, was “focused on equivalence, not safety” in Medtronic, Inc. v. Lohr, 518 U.S. 470, 493 (1996) (emphasis original).

We’ve already detailed a number of reasons why, at least after the 1990 Safe Medical Devices Act (“SMDA”), the Lohr decision is of questionable continuing validity, and we’re not going to repeat that today.  We’ve also discussed that predicate device safety are now evaluated in the FDA’s substantial equivalence determination. Not much court movement on these Lohr issues has occurred, but we remain warily hopeful.  Our interest in the FDA’s draft guidances is whether they undercut Lohr’s statement about the (1982 version of the) §510(k) process – by demonstrating that, in administering it, the FDA actually is concerned about the safety of “substantially equivalent” devices.  Remembering that draft, or even actual, FDA guidance documents do not have force of law, here’s what we found:

Best Practices for Selecting a Predicate Device

The most broadly applicable of the three draft guidances is entitled “Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission” and is available here.  A “predicate device” is the already marketed medical device against which the §510(k) “substantial equivalence” comparison is made. We searched this draft guidance for “safe” or “safety,” and yes, it did address the safety implications of predicate device selection – quite a bit (over 60 uses), actually:

  • The impetus for all three draft guidances arose from a 2018 FDA Safety Action Plan” “for modernizing measures to improve the safety of medical devices” by, inter alia, “improving safety by driving innovators toward reliance on more modern predicate devices.”  Predicate Device Draft Guidance, at 3.
  • The new device cannot have “different technological characteristics” that “raise different questions of safety” so “that the new device is as safe . . . as a predicate device.  FDA evaluates any “new/different technological characteristics’ effects on safety” of the new device.  Id. at 2.
  • Focusing on “the characteristics of predicate devices” rather than their “age” “will encourage the evolution of safer” devices because more recent predicates “include modern safety features due to rapid technological advances.”  Id. at 4.
  • “FDA considers it a best practice to select a predicate that was cleared using well-established methods, as this will . . . encourag[e] the evolution of safer . . . medical devices in the 510(k) program over time.”  Id. at 8.
  • The “best practice [is] to select a valid predicate device that continues to perform safely” “after considering how any reported medical device-related adverse events . . . may have a role in [the device’s] safety.”  Id. at 8.
  • Predicate devices should “not have unmitigated use-related or design-related safety issues, including consideration of emerging signals or safety communications.”    “FDA considers it a best practice to select a valid predicate device that is not associated with emerging signals or safety communications that relate to unmitigated use-related or design-related safety issues.”  Id. at 9 (footnote omitted).
  • A “510(k) Summary” must “provide[] an adequate summary of any information respecting safety.”  Id. at 11.  It should also “describe the ways performance testing was conducted to address any known safety . . . concerns with the predicate device.”  Id. at 12.

The predicate device draft guidance essentially is all about safety – as it should be.

Recommendations for the Use of Clinical Data

The second FDA draft guidance is “Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions,” available here.

  • This draft guidance was also created pursuant to the FDA’s “Safety Action Plan.” Clinical Data Draft Guidance at 2.
  • In addition to requiring no “different questions of safety, “FDA also weighs” a device’s benefits “against any probable risk of injury or illness from such use.”  Id. at 3 (footnote omitted).
  • Clinical data is necessary unless “a new device that is subject to 510(k) requirements can demonstrate SE [substantial equivalence] to a predicate device through robust non-clinical safety and performance data.”  Id. at 3.
  • “[W]hen considering whether data collected on a comparable device . . . may address certain questions of safety . . ., an adequate justification regarding the applicability of such data should be provided demonstrating why such data would be representative of the new device.  Id. at 4.
  • “[C]linical data often is used to determine whether the new device is ‘as safe and effective’ as a predicate device.”  Id. at 6.
  • New information about a device’s safety . . . may become available once the device is more widely . . . used in clinical practice.  In such cases, . . . there may be an awareness of new scientific information regarding a newly identified or increased risk of the predicate device, and clinical data may be needed to determine [substantial equivalence] in light of the new scientific information.  Id. at 11.

Thus, the chief reason the FDA requires submission of clinical data in connection with a §510(k) substantially equivalence determination is to address safety concerns.

Evidentiary Expectations for 510(k) Implant Devices

The third September 2023 draft FDA guidance is entitled “Evidentiary Expectations for 510(k) Implant Devices,” and is available here.  It addresses special considerations applicable to §510(k) implants (“a device that is placed into . . . of the human body” for at least 30 days).  It was also driven by safety concerns.

  • This draft guidance was also created pursuant to the FDA’s “Safety Action Plan.” Implant Draft Guidance at 1, 2.
  • Its “recommendations,” particularly “those related to identification and mitigation of certain risks associated with implants,” extend beyond initial §510(k) clearance to “the total product lifecycle.”  Id.
  • In addition to requiring no “different questions of safety, “FDA also weighs” a device’s benefits “against any probable risk of injury or illness from such use.”  Id. at 3 (footnote omitted).
  • Implant “submitters [should] consider whether testing should be provided to address safety . . . questions associated with wear or degradation, whether intended or unintended.”  “[T]esting” should “account[] for ‘worst-case’ implantation conditions.”  Id. at 7.
  • Implant testing should ensure that the device does not “increase the [following] risks . . . relative to the predicate” device:  (1) “everyday activities,” (2) “ongoing or future medical care,” (3) “reoperation or revision,” (4) “different patient populations,” (5) “duration of use,” (6) “user interaction with the implant,” including “maintenance” and “updates,” (7) “device design/ergonomics and human factors,” and (8) “implantation procedure, including shorter or longer operating time, infection, tissue damage.”  Id.
  • Submitters should also “consider[]” “non-clinical” risks as “an important part of efforts to continuously improve the safety of 510(k) Implants.”  Id. at 8.
  • Mandatory non-clinical risks are “biocompatibility,” which is addressed by a separate FDA guidance also applicable to PMA devices, and “at a minimum”: (1) “Cytotoxicity,” (2) “Sensitization,” (3) “Irritation or intracutaneous reactivity,” (4) “Acute systemic toxicity,” and (5)“Material-mediated pyrogenicity.”  Id. at 8-9.
  • Depending “on the particular nature of body contact,” the FDA’s implant guidance recommends a number of “[a]dditional endpoints”:  (1) “Subacute/subchronic toxicity,” (2) “Genotoxicity,” (3) “Implantation,” (4) “Hemocompatibility,” (5) “Chronic toxicity,” (6) “Carcinogenicity,” (7) “Reproductive/developmental toxicity,” and (8) “Degradation.”  Id. at 9.
  • The implant guidance further states that the “FDA expects most implants to be sterilized prior to implantation for patient safety,” which is also the subject of a separate agency guidanceId.
  • Since “[p]atients may live with an implant for years, or even permanently . . ., long-lasting implants [should] promote patient safety by minimizing the need for removal due to outdated software or other related vulnerabilities.”  Id. at 11.
  • “[S]ubmitters [should also] provide in their 510(k) submissions information regarding the device’s cybersecurity risks and related controls to assure device functionality and safety, consistent with” yet another separate FDA guidanceId. at 11-12.
  • “[T]he electrical safety and electromagnetic compatibility (EMC) of implants with electrical [should] components demonstrate conformity with consensus standards for electrical safety.  Id. at 12.
  • “[S]ubmitters [should] consider the risks associated with their device when exposed to an MR [Magnetic resonance] environment and provide information to support that those risks have been adequately mitigated,” as required by another separate guidance “on testing and labeling for implants for safety and compatibility.”  Id. at 13.
  • Beyond these specific issues, implant “testing should be conducted to evaluate safety . . . issues raised by differences between the new device and the predicate to demonstrate SE and help ensure that the device will perform safely . . . across its expected lifespan.”  Id. at 14.
  • Such additional testing “may be applicable and needed to demonstrate SE . . . when evaluating the risks associated with”:  (1) “corrosion,” (2)“fatigue,” (3) “degradation,” (4) “particulate characterization,” including “wear debris” and “particulates left over from manufacturing,” (5) “coating characterization,” and (6) “imaging . . . and radiotherapy compatibility.”  Id. at 14-16.
  • Among the types of device testing addressed by the Implant Draft Guidance are:  (1) “engineering analysis,” (2) “materials specifications,” (3) “finite element analysis,” (4) “bench model testing,” and (5) “animal testing,” particularly when “knowledge and refinement of surgical technique . . . is important for the device to be used safely.”  Id. at 16-17.
  • “For certain implants, information regarding raw materials and critical aspects of manufacturing and processing steps . . . may be important to understanding the safety . . . of the final, finished device.”  Id. at 18.
  • “[T]o evaluate the impact of differences between the user interfaces of the new device and the predicate device on safety,” submitters “should conduct a use-related risk analysis.”  Id. at 19.
  • There are even “scenarios where [human] clinical data may be needed to support an SE determination,” thus the FDA “encourages the collection, analysis, and 712 integration of patient experience data for implants.”  Id. at 20-21 (referencing numerous guidances and draft guidances).
  • Implant labeling “must include adequate information for the use of the device, including indications, effects, routes, methods, frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions, under which practitioners licensed by law to employ the device can use the device safely.”  Id. at 22.
  • The FDA “recommend that manufacturers provide patient information . . ., which will help to ensure the implant is used safely,” particularly, “permanent implants may have risks for which labeling is especially important for safety during everyday activities or other medical procedures.”  Id. at 22.
  • “[T]o help ensure continued safety over the expected lifespan of the implant, FDA considers it important for manufacturers to provide patients with . . . an implant ID card.”  Id.

As for the safety aspects of the Implant Draft Guidance, all we can say is, “wow.”  The implant guidance would import into a §510(k) substantial equivalence determination essentially every device safety issue that we’ve ever seen litigated in medical device litigation – from simple fatigue failures, to electric shocks, to revision surgery, to biocompatibility, to cancer risks.  The FDA’s draft covers both design safety and risk-related warnings, including warnings that implanting surgeons could give to their patients.

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To us, none of this is unexpected.  The FDA is – rightfully – a safety-oriented agency.  The SMDA and subsequent FDCA statutory amendments provided the FDA with all the necessary safety-related authority to correct whatever safety-related deficiencies that the Supreme Court perceived in the 1980s version of §510(k) that it considered in Lohr.  At this point, every court that blindly continues quoting Lohr for the proposition that §510(k) involves only “equivalence, not safety” is not being honest.  The nature of the FDA’s substantial equivalence determination has fundamentally changed since the days of Lohr, and the concerted refusal of post-Lohr courts to recognize this fact is increasingly hard to justify.