# Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior

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URL: https://www.frixlaw.com/law-library/documents/fr%3A2020-04328

## Record

- **Collection:** Federal Register
- **Document type:** Rule
- **Published:** March 6, 2020
- **Citation:** 85 FR 13312

## Text

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 882 and 895
[Docket No. FDA-2016-N-1111]
Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA, the Agency, or we) is finalizing a ban on electrical stimulation devices (ESDs) for self-injurious or aggressive behavior. FDA has determined that these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling. This ban includes both new devices and devices already in distribution and use; however, this ban provides transition time for those individuals currently subject to ESDs for the identified intended use to transition off ESDs under the supervision of a physician.

DATES:

This rule is effective April 6, 2020. However, compliance for devices currently in use and subject to a physician-directed transition plan is required on September 2, 2020. Compliance for all other devices is required on April 6, 2020.

ADDRESSES:

For access to the docket to read background documents or comments received, go to
https://www.regulations.gov/
and insert the docket number found in brackets in the heading of this final rule into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Rebecca Nipper, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1540, Silver Spring MD 20993-0002, 301-796-6527,
rebecca.nipper@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary

A. Purpose of the Final Rule

B. Summary of the Major Provisions of the Final Rule

C. Legal Authority

D. Costs and Benefits

II. Table of Abbreviations and Acronyms

III. Background and Determination

A. Public Participation, Clarifications, and Key Changes

B. FDA's Determination That ESDs for SIB or AB Present an Unreasonable and Substantial Risk of Illness or Injury

IV. Legal Authority

V. Comments on the Proposed Rule and FDA's Responses

A. Background Information About ESDs, SIB, and AB

B. Evidence Interpretation

C. Risks of ESDs for SIB or AB

D. Effects of ESDs on SIB and AB

E. State of the Art for the Treatment of SIB and AB

F. Labeling and Correcting or Eliminating Risks

G. Legal Issues

H. Transition Time

VI. Effective Date and Compliance Dates

VII. Economic Analysis of Impacts

VIII. Analysis of Environmental Impact

IX. Paperwork Reduction Act of 1995

X. Federalism

XI. References

I. Executive Summary

A. Purpose of the Final Rule

FDA is banning ESDs for self-injurious behavior (SIB) or aggressive behavior (AB). ESDs are aversive conditioning devices that apply a noxious electrical stimulus (a shock) to a person's skin to reduce or cease such behaviors. SIB and AB frequently manifest in the same individual, and people with intellectual or developmental disabilities exhibit these behaviors at disproportionately high rates. Notably, many such people have difficulty communicating and cannot make their own treatment decisions because of such disabilities, meaning many people who exhibit SIB or AB are part of a vulnerable population. SIB commonly includes head-banging, hand-biting, excessive scratching, and picking of the skin. However, SIB can be more extreme and result in: (1) Bleeding; (2) broken, even protruding bones; (3) blindness from eye-gouging or poking; (4) other permanent tissue damage; or (5) injuries from swallowing dangerous objects or substances. AB involves repeated physical assaults and can be a danger to the individual, others, or property. In this rule, like much of the scientific literature, we discuss SIB and AB in tandem and use the phrase “SIB or AB” to refer to SIB or AB or both.

Although the available data and information show that some individuals subject to ESDs exhibit an immediate interruption of the targeted behavior, the available evidence has not established a durable long-term conditioning effect or an overall-favorable benefit-risk profile for the devices. The medical literature shows that ESDs present risks of a number of psychological harms including depression, posttraumatic stress disorder (PTSD), anxiety, fear, panic, substitution of other negative behaviors, worsening of underlying symptoms, and learned helplessness (becoming unable or unwilling to respond in any way to the ESD); and the devices present the physical risks of pain, skin burns, and tissue damage.

Because the medical literature likely underreports adverse events (AEs), risks identified through other sources, such as from experts in the field, State agencies that regulate ESD use, and records from the only facility that has recently manufactured and is currently using ESDs for SIB or AB, demand closer consideration. As discussed in the proposed rule, these sources further support the risks reported in the literature and indicate that ESDs pose additional risks such as suicidality, chronic stress, acute stress disorder, neuropathy, withdrawal, nightmares, flashbacks of panic and rage, hypervigilance, insensitivity to fatigue or pain, changes in sleep patterns, loss of interest, difficulty concentrating, and injuries from falling. State-of-the-art treatments for SIB and AB further demonstrate that the risks of ESDs for SIB or AB are unreasonable.

The ESDs subject to this ban are aversive conditioning devices intended to reduce or cease SIB or AB. Aversive conditioning pairs a noxious stimulus, such as a noxious electric shock delivered to an individual's skin by an ESD, with a target behavior such that the individual begins to associate the noxious stimulus with the behavior. The intended result is that the individual ceases engaging in the behavior and, over time, becomes conditioned not to manifest the target behavior. Some ESDs are intended for other purposes, such as smoking cessation; however, the ban includes only those devices intended to reduce or eliminate SIB or AB. ESDs are not used in electroconvulsive therapy, sometimes called electroshock therapy or ECT, which is unrelated to this rulemaking.

The effects of the shock are both psychological (including suffering) and physical (including pain), each having a complex relationship with the electrical parameters of the shock. As a result, the subjective experience of the person receiving the shock can be difficult to predict. Physical reactions roughly correlate with the peak current of the shock delivered by the ESD. However, various other factors such as sweat, electrode placement, recent history of shocks, and body chemistry can physically affect the sensation. As a result, the intensity or pain of a particular set of shock parameters can vary from person to person and from

shock to shock. Possible adverse psychological reactions are even more loosely correlated with shock intensity. The shock need only be subjectively stressful enough to cause trauma or suffering. Trauma becomes more likely, for example, when the recipient does not have control over the shock or has developed a fear of future shocks, neither of which is an electrical parameter of the shock.

In light of scientific advances, out of concern for ethical treatment, and in an attempt to create generalizable interventions that work in community settings, behavioral scientists have developed safer, successful treatments for SIB and AB. The development of the functional behavioral assessment, a formalized tool to analyze and determine triggering conditions, has allowed providers to formulate and implement plans based on positive behavioral techniques. As a result, multielement positive interventions (
e.g.,
paradigms such as positive behavior support or dialectical behavioral therapy) have become state-of-the-art treatments for SIB and AB. Such interventions achieve success through environmental modification and an emphasis on teaching appropriate skills. Behavioral intervention providers may also recommend pharmacotherapy (the use of medications) as an adjunctive or supplemental method of treatment. Positive-only approaches have low risk and are generally successful even for challenging SIB and AB, in both clinical and community settings. The scientific community has recognized that addressing the underlying causes of SIB or AB, rather than suppressing it with painful shocks, not only avoids the risks posed by ESDs, but can achieve durable, long-term benefits.

Based on all available data and information, FDA has determined that the risk of illness or injury posed by ESDs for SIB or AB is substantial and unreasonable and that labeling or a change in labeling cannot correct or eliminate the unreasonable and substantial risk of illness or injury.

B. Summary of the Major Provisions of the Final Rule

This ban only includes aversive conditioning devices that apply a noxious electrical stimulus to a person's skin to reduce or cease aggressive or self-injurious behavior. The ban applies to devices already in commercial distribution and devices already sold to the ultimate (end) user, as well as devices to be sold or commercially distributed in the future. A banned device is an adulterated device, subject to enforcement action. The ban does not, however, prevent further study of such devices pursuant to an investigational device exemption, if the requirements for such are met.

C. Legal Authority

An ESD used for SIB or AB is a “device” as defined by the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FD&C Act authorizes FDA to ban a device intended for human use by regulation if we find, on the basis of all available data and information, that such a device presents substantial deception or an unreasonable and substantial risk of illness or injury, which cannot be corrected by labeling or a change in labeling. A banned device is adulterated except to the extent it is being studied pursuant to an investigational device exemption. This final rule is also issued under the authority to issue regulations for the efficient enforcement of the FD&C Act.

D. Costs and Benefits

Under this final rule we are banning ESDs for SIB or AB. Because we lack sufficient information to quantify the benefits, we include a qualitative description of some potential benefits of the final rule. We expect that the rule will affect only one entity. In addition to the incremental costs this entity will incur to comply with the requirements of the final rule, the ban may create potential transfer payments of between $14 million and $15 million annually, either within the affected entity or between entities. The present value of total costs over 10 years ranges from $0 million to $44 million, with a primary estimate of $22 million at a three percent discount rate, and ranges from $0 million to $38 million, with a primary estimate of $18.8 million at a seven percent discount rate. Annualized costs range from $0 million to $5.0 million, with a primary estimate of $2.5 million at a three percent discount rate, and range from $0 million to $5.0 million, with a primary estimate of $2.5 million at a seven percent discount rate.

II. Table of Abbreviations and Acronyms

Abbreviation or acronym
What it means

AB
Aggressive behavior.

ABA
Applied behavior analysis.

ABC-I
Aberrant Behavior Checklist—Irritability (scale).

ADHD
Attention deficit hyperactivity disorder.

AE
Adverse event.

APA
American Psychiatric Association.

ASD
Autism spectrum disorder.

DBT
Dialectical behavioral therapy.

DDS
(Massachusetts) Department of Developmental Services.

DEEC
(Massachusetts) Department of Early Education and Care.

DMDD
Disruptive mood dysregulation disorder.

DPPC
(Massachusetts) Disabled Persons Protection Committee.

DSM
Diagnostic and Statistical Manual of Mental Disorders.

EA
Environmental assessment.

ESD
Electrical stimulation device.

FAS
Fetal alcohol syndrome.

FBA
Functional behavioral assessment.

FD&C Act
Federal Food, Drug, and Cosmetic Act.

FONSI
Finding of no significant impact.

GED
Graduated Electronic Decelerator.

ICD
Implantable cardioverter defibrillator.

JRC
Judge Rotenberg Educational Center, Inc.

MDD
Major depressive disorder.

NASDDDS
National Association of State Directors of Developmental Disability Services.

NDD
Neurodevelopmental disorder.

NYSED
New York State Education Department.

PBS
Positive behavioral support.

PKU
Phenylketonuria.

PTSD
Post traumatic stress disorder.

SIB
Self-injurious behavior.

SIBIS
Self-Injurious Behavior Inhibiting System.

SNRI
Serotonin-norepinephrine reuptake inhibitor.

SSRI
Selective serotonin reuptake inhibitor.

III. Background and Determination

On April 25, 2016, FDA published a proposed rule to ban ESDs used to treat SIB or AB and requested comments on the proposal (81 FR 24386).
1

As explained in the proposed rule, ESDs for SIB or AB are aversive conditioning devices that apply a noxious electrical stimulus (a shock) to a person's skin to reduce or cease such behaviors. Although FDA cleared a few of these devices more than 20 years ago, due to scientific advances and ethical concerns tied to the risks of ESDs, state-of-the-art medical practice has evolved away from their use and toward various positive behavioral treatments, sometimes combined with pharmacological treatments. Only one facility in the United States has manufactured these devices or used them on individuals in recent years. As a result of this evolution in treatment over the past several decades, the available data and information on the risks and benefits of ESDs are limited.

1
Available at
https://www.federalregister.gov/documents/2016/04/25/2016-09433/banned-devices-proposal-to-ban-electrical-stimulation-devices-used-to-treat-self-injurious-or.

A. Public Participation, Clarifications, and Key Changes

FDA convened a meeting of the Neurological Devices Panel of the Medical Devices Advisory Committee (“the Panel”) on April 24, 2014 (“the Panel Meeting”), in an open public forum, to discuss issues related to FDA's consideration of a ban on ESDs for SIB or AB (see 79 FR 17155, March 27, 2014
2

; Ref. 1). FDA is not required to hold a panel meeting before banning a device, but FDA decided to do so in the interest of gathering as much data and information as possible, from experts in relevant medical fields as well as all interested stakeholders, and in the interest of obtaining independent expert advice on the scientific and clinical matters at issue. In considering whether to ban ESDs, FDA also conducted an extensive, systematic literature review to assess the benefits and risks associated with ESDs as well as alternative treatments for patients exhibiting SIB and AB.

2
Available at
https://www.federalregister.gov/documents/2014/03/27/2014-06766/neurological-devices-panel-of-the-medical-devices-advisory-committee-notice-of-meeting-request-for.

FDA invited interested parties to comment on the proposed rule by May 25, 2016. However, we received a request to extend the comment period and, in the
Federal Register
of May 23, 2016, we announced a 60-day extension, ending July 25, 2016 (81 FR 32258).
3

In addition to requesting comments on the proposal generally, we specifically sought comments on the determinations that the risk of illness or injury posed by ESDs for SIB or AB is unreasonable and substantial, and that labeling or a change in labeling cannot correct or eliminate the unreasonable and substantial risk of illness or injury. We also sought comments on other issues related to the proposal to ban these devices.

3
Available at
https://www.federalregister.gov/documents/2016/05/23/2016-12026/banned-devices-proposal-to-ban-electrical-stimulation-devices-used-to-treat-self-injurious-or.

FDA received more than 1,500 comments from several types of stakeholders. We received hundreds of comments from parents of individuals with intellectual and developmental disabilities. We received comments from several people who have themselves manifested SIB and AB in their lifetimes. We received submissions from dozens of State agencies and their sister public-private organizations. We received comments from the affected manufacturer and residential facility, some of its employees, and parents of individual residents. State and Federal legislators also expressed interest, as did State and national advocacy groups.

For this rulemaking, we also associated the Panel Meeting docket with this action (Docket No. FDA-2014-N-0238) and considered the approximately 300 comments submitted to the Panel Meeting docket. The types of stakeholders and the concerns they raised were similar to the comments on the proposed rule, in which we discussed many of the Panel Meeting comments in detail.

The overwhelming majority of comments supported this ban. The comments in opposition to this ban were primarily from the Judge Rotenberg Center (JRC) and people affiliated with JRC; this includes comments made during the Panel Meeting and through submission of comments to the Panel Meeting docket. Specifically, these comments were from three former JRC residents, family members of individuals on whom ESDs have been used at JRC (one of the parents association comments included 32 letters from family members), a former JRC clinician, a Massachusetts State Representative, and one concerned citizen.

In its comments on the proposed rule, JRC included the hearing transcripts and exhibits from a recent Massachusetts court proceeding that considered the use of ESDs, in particular the Judge Rotenberg Center's (JRC's) graduated electronic decelerator (GED) devices.
See Judge Rotenberg Center, Inc., et al.,
v.
Comm'r of the Dep't of Developmental Servs., et al.,
Docket No. 86E-0018-GI (Bristol, Mass. Probate and Family Court, June 20, 2018) (Mass. Docket No 86E-0018-GI). Therefore, some expert testimony from these transcripts is discussed in this final rule to the extent the testimony is relevant to the risks or benefits of ESDs for SIB or AB, or to the state of the art of treatment for this patient population.
4

However, the issues in that State proceeding are different from the ones in FDA's ban proceeding, and the court's decision has no legal or scientific bearing on this ban.

4
Any references to hearing transcripts or hearing exhibits herein refer to transcripts and exhibits from Mass. Docket No. 86E-0018-GI.

The Bristol County (Massachusetts) Probate and Family Court considered whether a consent decree should be vacated based on significant changes in fact or law, in particular whether the professional consensus is that JRC's GED does not now conform to the accepted standard of care for treating individuals with intellectual and developmental disabilities. The court ultimately determined that no significant change in consensus warranted vacating the consent decree: “the evidence at the hearing did not establish that there is a professional consensus with respect to whether Level III aversive treatment [use of ESDs]

conforms to the accepted standard of care.” (Opinion at 48). The professional consensus regarding the accepted standard of care and such use of ESDs is not an issue in this ban. Rather, to ban a device under section 516 of the FD&C Act (21 U.S.C. 360f), FDA must determine the device presents an “unreasonable and substantial risk of illness or injury.” As explained in the proposed rule, in making this determination, FDA analyzes whether the risks the device poses to individuals are important, material, or significant in relation to its benefits to the public health, and FDA compares those risks and benefits to the risks and benefits posed by alternative treatments being used in current medical practice (81 FR 24386 at 24388).

Compared to the proposed rule, we have made minor changes to the codified text of the classification regulation to make clear that only ESDs, not other aversive devices for SIB or AB, are banned. We have also added text to the device type classification to make clear that this ban is not a special control. We reconsidered a few of the representations and attributions of data and information made in the proposed rule. Our explanation of these changes, as well as our explanation why the revisions did not affect our overall evaluation of the benefit-risk profile and our ultimate conclusion with respect to the substantial and unreasonable risk of illness or injury from ESDs used for SIB or AB, are in section V.C. in the corresponding comment responses.

B. FDA's Determination That ESDs for SIB or AB Present an Unreasonable and Substantial Risk of Illness or Injury

FDA considered all available data and information from a wide variety of sources, including the data and information submitted to the docket for the Panel Meeting and proposed rule: scientific literature, information and opinions from experts, information from State agencies that also regulate ESDs as well as their actions on ESDs, information from the affected manufacturer/residential facility, information from individuals subject to ESDs and their family members, and information from disability rights groups, other government entities, and other stakeholders. In weighing each piece of data and information, FDA took into account its quality, such as the level of scientific rigor supporting it, the objectivity of its source, its recency, and any limitations that might weaken its value. Thus, for example, we gave much more weight to the results of a study reported in a peer-reviewed journal by an objective author than we did to anecdotal evidence.

As discussed in detail in the comment responses in section V, although we found that certain risks had weaker support than we asserted in the proposed rule, other information submitted in comments provided greater support for other risks. We continue to find that the medical literature shows that ESDs present a number of psychological risks including depression, PTSD, anxiety, fear, panic, substitution of other negative behaviors, worsening of underlying symptoms, and learned helplessness; and the devices present the physical risks of pain, skin burns, and tissue damage. Because the medical literature suggests an underreporting of AEs, FDA carefully evaluated risks identified through other sources, such as from experts in the field, State agencies that regulate ESD use, and records from the only facility that is currently using ESDs for SIB or AB. As discussed in the proposed rule, these sources further support the risks reported in the literature and indicate that ESDs have been associated with additional risks such as suicidality, chronic stress, acute stress disorder, neuropathy, withdrawal, nightmares, flashbacks of panic and rage, hypervigilance, insensitivity to fatigue or pain, changes in sleep patterns, loss of interest, difficulty concentrating, and injuries from falling.

Although the available data and information show that some individuals subject to ESDs may exhibit an immediate interruption of the targeted behavior, the available evidence has not established a durable conditioning effect or an overall-favorable benefit-risk profile for ESDs for SIB or AB. No randomized, controlled clinical trials have been conducted, and the studies that have been conducted are very small and suffer from various limitations, including the use of concomitant treatments that make determining the cause of any behavioral changes difficult. The additional references cited in the comments on the proposed rule suffer from the same methodological and other limitations as those FDA considered previously, and the records and summaries JRC submitted regarding its residents constitute an even weaker source of evidence regarding the effectiveness of ESDs for SIB or AB.

State-of-the-art treatments for SIB and AB are positive-based behavioral approaches along with pharmacotherapy, as appropriate. The medical community now broadly recognizes that conducting careful functional assessments and addressing the underlying causes of SIB and AB rather than suppressing behaviors with shocks not only avoids the risks posed by ESDs, but can achieve durable, long-term benefits. As a result, research on the use of positive behavioral methods continues to grow; literature published since the proposed rule shows even greater success than described previously, as detailed in section V. Further, recent advancements in psychiatric research and clinical care have improved the understanding of psychiatric diagnosis and treatment, particularly in individuals with intellectual and developmental disabilities. This has facilitated the use of pharmacological treatments that reduce SIB and AB, whether the drug products target SIB or AB symptoms directly, regardless of the underlying condition, or by more indirectly reducing SIB and AB by improving the underlying condition. ESDs are only used at one facility in the United States on individuals from a small number of States, and there is evidence, including from the Massachusetts hearing, that the overwhelming majority of patients exhibiting SIB or AB throughout the country are being treated without the use of ESDs. Although positive behavioral interventions may not always be completely successful in all patients, the literature shows that they are typically successful, on their own or in conjunction with pharmacotherapy, regardless of the severity of the behavior targeted or the setting, and can achieve durable long-term results while avoiding the risks posed by ESDs.

Based on the serious risks posed by ESDs for SIB or AB, the inadequacy of data to support their effectiveness, and the positive benefit-risk profiles of the state-of-the-art alternatives for the treatment of SIB or AB, FDA has determined that the risks posed by ESDs for SIB or AB are important, material, or significant in relation to their benefits to the public health, and that ESDs present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling. FDA has decided to ban these devices under section 516 of the FD&C Act. This rule applies to devices already in distribution and use, as well as to future distribution of these devices. The vulnerable population subject to ESDs for SIB or AB, like all individuals, are entitled to the public health protections under the FD&C Act.

IV. Legal Authority

An ESD used for SIB or AB is a “device” as defined under section 201(h) of the FD&C Act (21 U.S.C. 321(h)). Section 516 of the FD&C Act authorizes FDA to ban a device

intended for human use by regulation if it finds, on the basis of all available data and information, that such a device presents substantial deception or an unreasonable and substantial risk of illness or injury, which cannot be corrected or eliminated by labeling or change in labeling (21 U.S.C. 360f(a)(1) and (2)). A banned device is adulterated under section 501(g) of the FD&C Act (21 U.S.C. 351(g)), except to the extent it is being studied pursuant to an investigational device exemption under section 520(g) of the FD&C Act (21 U.S.C. 360j(g)). This rule is also issued under section 701(a) of the FD&C Act (21 U.S.C. 371(a)), which provides authority to issue regulations for the efficient enforcement of the FD&C Act.

In determining whether a deception or risk of illness or injury is “substantial,” FDA will consider whether the risk posed by the continued marketing of the device, or continued marketing of the device as presently labeled, is important, material, or significant in relation to the benefit to the public health from its continued marketing (see 21 CFR 895.21(a)(1)). Although FDA's device banning regulations do not define “unreasonable risk,” in the preamble to the final rule issuing 21 CFR part 895, FDA explained that, with respect to “unreasonable risk,” we will conduct a careful analysis of risks associated with the use of the device relative to the state of the art and the potential hazard to patients and users (44 FR 29214 at 29215, May 18, 1979).
5

The state of the art with respect to this rule is the state of current technical and scientific knowledge and medical practice with regard to the treatment of patients exhibiting self-injurious and aggressive behavior.

5
Available at
https://www.govinfo.gov/content/pkg/FR-1979-05-18/pdf/FR-1979-05-18.pdf.

Thus, in determining whether a device presents an “unreasonable and substantial risk of illness or injury,” FDA analyzes the risks and the benefits the device poses to individuals, comparing those risks and benefits to the risks and benefits posed by alternative treatments being used in current medical practice. Actual proof of illness or injury is not required; FDA need only find that a device presents the requisite degree of risk on the basis of all available data and information (H. Rep. 94-853 at 19; 44 FR 29214 at 29215).

Whenever FDA finds, on the basis of all available data and information, that the device presents substantial deception or an unreasonable and substantial risk of illness or injury, and that such deception or risk cannot be, or has not been, corrected or eliminated by labeling or by a change in labeling, FDA may initiate a proceeding to ban the device (see 21 CFR 895.20). If FDA determines that the risk can be corrected through labeling, FDA will notify the responsible person of the required labeling or change in labeling necessary to eliminate or correct such risk (see 21 CFR 895.25).

FDA notes that a banned device is not barred from clinical study under an investigational device exemption pursuant to section 520(g) of the FD&C Act. However, any such study must meet all applicable requirements, including but not limited to, those for: protection of human subjects (21 CFR part 50), financial disclosure by clinical investigators (21 CFR part 54), approval by institutional review boards (21 CFR part 56), and investigational device exemptions (21 CFR part 812).

V. Comments on the Proposed Rule and FDA's Responses

In the proposed rule, in addition to seeking comment on our determination of substantial and unreasonable risk that cannot be corrected or eliminated with a change in labeling, we sought comments on other issues such as how long transitions away from ESDs for SIB or AB may take as well as the proposed effective date. We also requested comments on the proposed regulatory impact (economic) analysis. We have divided the comments and responses by subject matter, organized like the proposed rule: background information, evidence interpretation, risks of ESDs for SIB or AB, effects of ESDs on SIB or AB, state-of-the-art for the treatment of SIB or AB, labeling and correcting or eliminating risks, legal issues, and finally, transition time. Of the comments to the docket, the overwhelming majority supported a finding of substantial and unreasonable risk that cannot be corrected or eliminated with a change in labeling. The comments related to transitioning away from ESDs for SIB or AB, as well as the proposed effective date, supported no transition time and an immediate effective date. We received no comments on the proposed regulatory impact analysis.

Any comments received relating to ECT are outside the scope of this rulemaking, and consequently, we do not address those comments. We issued a Final Order on ECTs in 2018. (see 83 FR 66103, December 26, 2018).
6

6
Available at
https://www.federalregister.gov/documents/2018/12/26/2018-27809/neurological-devices-reclassification-of-electroconvulsive-therapy-devices-effective-date-of.

We describe and respond to the comments in this section. We have numbered each comment to help distinguish between different comments. We have grouped similar comments together under the same number, and in some cases, we have separated different issues discussed in the same comment and designated them as distinct comments for purposes of our responses. The number assigned to each comment or comment topic is purely for organizational purposes and does not signify the comment's value or importance or the order in which comments were received. As most of the comments support this ban without raising questions or concerns, our responses primarily relate to the few comments that do not support the ban.

A. Background Information About ESDs, SIB, and AB

(Comment 1) A comment states that FDA's characterization of behaviors associated with SIB and AB is broadly true but does not adequately convey the extreme behaviors exhibited by some individuals on whom ESDs are used. The comment states that such behaviors can put both the patients and caregivers at immediate risk of irreparable, serious, and even life-threatening injury.

(Response) FDA agrees with the commenter that in some cases the behaviors exhibited by individuals with SIB or AB are extreme and could cause serious injury to the individual or their caregiver. As stated in the proposed rule, SIB commonly includes: Head-banging, hand-biting, excessive scratching, and picking of the skin. However, SIB can be more extreme and result in bleeding; broken and even protruding bones; blindness from eye-gouging or poking; other permanent tissue damage; or injuries from swallowing dangerous objects or substances. AB involves repeated physical assaults and can be a danger to the individual, others, or property. We referred in the proposed rule to a JRC submission that states a link between SIB and death. Thus, FDA has taken into account the extremity of behaviors associated with SIB and AB.

(Comment 2) A comment states that FDA incorrectly defined the intended use population for ESDs and, in doing so, overstated the limited patient population that uses ESDs for SIB or AB. The commenter asserts that FDA has performed an erroneous benefit-risk analysis by “improperly inflating the intended use population by orders of magnitude.”

(Response) FDA disagrees with this assertion. The commenter has incorrectly interpreted FDA's estimates,

which we explained in the proposed rule. The commenter focuses on the narrow “patient population that uses ESD therapy for SIB and AB” whereas FDA's estimate more broadly refers to the total number of individuals in the United States who exhibit SIB and AB (330,000) and the number of the most extreme cases (25,000), regardless of how they are treated (81 FR 24386 at 24389).

We based these numbers on the scientific literature, which shows that the prevalence of SIB in individuals with intellectual or developmental disabilities ranges from 2.6 percent to 40 percent, or 2 to 23 percent in community samples (Ref. 2). More recently, one analysis found a prevalence of SIB in a clinical population of children with developmental disabilities at 32 percent, suggesting that the actual prevalence may be at the high end of earlier estimates (Ref. 3). Further, estimates of the prevalence of AB in individuals with intellectual or developmental disabilities range as high as 52 percent, though 10 percent is more commonly reported (Ref. 2). Thus, by conservative estimates, based on a population of 330 million in which 1 to 3 percent of individuals have intellectual or developmental disabilities (and counting only them, not all people who manifest SIB or AB), at least 330,000 people in the United States manifest SIB, AB, or both; less conservative estimates are much higher (see Ref. 2).

Elsewhere in its comments, the commenter, JRC, appears to agree with FDA's estimates of 330,000 and 25,000 but explains that it enrolls an even smaller subset of the most severe, refractory residents. This represents, in its view, the totality of the intended use population for ESDs for SIB or AB, which in 2016 numbered 51 individuals from 12 States.

FDA does not contest that ESDs for SIB or AB were, in 2016, used on about 51 individuals in the United States, or that these individuals come from 12 States (in the proposed rule, FDA estimated the number of States to be 6-11 (81 FR 24386 at 24408)). Indeed, as explained in the comment responses about the state of the art, the professional field, with the sole exception of JRC, has moved beyond the use of ESDs for SIB or AB. However, FDA continues to believe that 25,000 is a reliable, conservative estimate for the number of the more extreme cases of SIB and AB in the United States. We have no evidence establishing that, of those, JRC receives the most extreme or refractory cases. The comment does not provide evidence of this other than contending that ESDs are only used after all alternative treatments have failed and offering some documentation purporting to show as much. This does not mean that JRC is unique in encountering severe cases. Rather, this shows that JRC is unique in which methods it chooses to employ. We have evidence that extreme cases are treated elsewhere in the United States without the use of ESDs, as discussed in more detail in the comment responses regarding the state of the art. Thus, in considering the number of more extreme cases in the United States compared to the limited number and geographic origins of patients subject to ESDs at JRC, we continue to believe that JRC's patients are not uniquely refractory or responsive to ESDs.

(Comment 3) A comment argues that applying the ban only to a discrete use of ESDs in one type of patient population, instead of all aversive conditioning devices, is arbitrary. The comment specifically outlines several shock aversive products and uses that FDA is not proposing to ban, including skin shock products for smoking cessation, alcohol and drug addiction, and other “bad habits,” shock aversives for inappropriate sexual behavior after traumatic brain injury, and shock aversives for nonsuicidal self-injury cutting behaviors. The commenter states that FDA has not provided a discussion or rationale distinguishing why the risks of skin shock are acceptable for these devices for these other conditions and not for the treatment of patients with SIB and AB. The commenter further argues that FDA's distinction based on patient control over the shocks is misplaced because in all cases, parental or guardian consent is required and obtained.

(Response) The commenter is correct in that this rule only applies to ESDs for SIB or AB and not to ESDs for other intended uses. FDA explained in the proposed rule that, although these products have parallels in technology and behavior modification strategy, products for other uses address different conditions or behaviors in different patient populations, and as a result, they present different benefit-risk profiles. We explained, for example, that many people who exhibit SIB or AB have disabilities that present vulnerabilities, such as difficulty communicating pain and other harms caused by ESDs, not likely to be present in people who use ESDs for other purposes. As a result, individuals who exhibit SIB or AB would bear a higher risk of injury or illness from the shock than, for example, smokers who choose to use an ESD to help quit smoking. Smokers can immediately communicate pain to the device's controller or remove the device themselves. They can communicate symptoms of other harms that may be caused by ESDs to their healthcare provider, which may lead to discontinuation of the device's use, or decide to stop using the device. In addition, people who exhibit SIB or AB may not be able to associate cause and effect or, as with some people with an autism spectrum disorder (ASD), they may express pain atypically or not at all.

ESDs for other intended uses also differ from ESDs for SIB or AB with respect to whether the individual subject to the shocks has control over them as well as the level of control they have. FDA recognizes that, at the facility that still uses ESDs for SIB or AB, legal consent is obtained to use the devices. However, the person who provides legal consent is typically not the person subject to the risks of the use of the device. This distinction is significant because consent does not mitigate the risk in that the person subject to the risk has no control over use of the device. For example, a person who fears future shocks could not opt out and thereby reduce the fear. Similarly, a person who experiences extreme pain or suffering could not opt out to avoid those harms in the future. FDA is not questioning the validity or importance of legal consent, but rather pointing out that legal consent does not eliminate concerns related to the shock recipients' communication difficulties and lack of control over use of the device on them.

B. Evidence Interpretation

(Comment 4) Many comments state that FDA's analysis for the proposed rule was thorough and well supported. Some of them characterize the evidence for the ban as strong and contrast that with the evidence for the effectiveness of ESDs for SIB or AB, which they characterize as weak.

(Response) FDA agrees. As we stated in the proposed rule, FDA first conducted an extensive, systematic literature review to assess the benefits and risks associated with ESDs as well as the state of the art of treatment of patients exhibiting SIB or AB. As we explained in the proposed rule, SIB and AB were considered in tandem, and these conditions presented in individuals with intellectual and developmental disabilities, such as ASD, Down syndrome, Tourette's syndrome, as well as other cognitive or psychiatric disorders and severe intellectual impairment (including a broad range of intellectual measures). The studies encompassed both children and adults.

As noted in section III.B, FDA convened the Panel Meeting on April 24, 2014, in an open public forum, to discuss issues related to FDA's consideration of a ban of ESDs for SIB or AB (see 79 FR 17155). Although FDA is not required to hold a panel meeting before banning a device, FDA decided to do so in the interest of gathering as much data and information as possible, from experts in relevant medical fields as well as all interested stakeholders, and in the interest of obtaining independent expert advice on the scientific and clinical matters at issue. Eighteen panelists with expertise in both pediatric and adult patients represented the following biomedical specialties: Psychology, psychiatry, neurology, neurosurgery, bioethics, and statistics; panelists included representatives for patients, industry, and consumers (Ref. 4). FDA provided a presentation that described the banning standard, the regulatory history of aversive conditioning devices, alternative treatments, and a summary of the benefits and risks of ESDs, including a comprehensive, systematic literature review based on the information available at that time (see generally Refs. 5 and 6). After the Panel Meeting, FDA reviewed approximately 300 comments submitted to the public docket created for the Panel Meeting (Docket No. FDA-2014-N-0238). FDA associated that docket with this rulemaking and considered those comments in this rulemaking, as appropriate.

(Comment 5) A comment asserts that FDA ignored, misrepresented, and distorted the available information and data, favoring evidence that supports the ban while dismissing evidence that supports the use of ESDs for SIB or AB.

(Response) FDA disagrees and addresses the commenter's assertions regarding specific information and data in separate comment responses in this final rule. FDA has thoroughly and fairly reviewed the available data and information, with multiple opportunities for input from stakeholders on all sides of the issue. FDA considered all additional information timely submitted to the docket in this rulemaking, including comments by the public. The public comments included data and information as well as court documents (including transcripts and exhibits) from litigation related to the use of ESDs for SIB or AB. In some cases, as explained in responses to various comments, the comments led FDA to reconsider and change its evaluations of particular sources. In other cases, the docket information repeated previously received material, thus reinforcing our evaluation. Some information was not relevant, for example, when it sought to refute a premise that FDA did not rely upon in the proposed ban.

However, FDA did not dismiss evidence that supports the use of ESDs for SIB or AB. We weighed all available data and information, taking into account its quality, such as the scientific rigor supporting it, the objectivity of its source, its recency, and any limitations that might weaken its value. Scientific rigor is greater when the study includes randomization or other controls and covers a large number of subjects. For less controlled studies, such as a case report, a greater number of study subjects across many reports will generally bolster confidence, for example, when many case reports are examined within a meta-analysis. Thus, we generally gave more weight to observations under controlled conditions than to reports of anecdotes. Similarly, peer review bolsters confidence because the process allows other experts to question or critique potential inaccuracies or errors. We generally gave more weight to the results of a study in a peer-reviewed journal than we did to non-peer-reviewed papers.

We considered the opinions of Panel members and other experts, some of whom support the use of ESDs for SIB or AB and some of whom do not. We generally gave more weight to expert opinions about scientific subjects than opinions from laypersons about scientific subjects. Although expert opinions are generally weaker scientific evidence than studies, the weight of such opinions is increased, for example, when they report data or include confirmatory or supportive citations to peer-reviewed scientific references, the subject matter is within the offeror's expertise, the opinion is based on regular professional practice or first-hand experiences, and/or the offeror is free from conflicts of interest. We considered opinions from commenters and others, including individuals at JRC, their parents, JRC staff, and JRC itself although such opinions merit relatively less weight in drawing scientific conclusions.

We explained in the proposed rule, and throughout this final rule, how this evidence relates to our conclusions and the strength of the evidence as it pertains to those conclusions. While the commenter may or may not agree with how we weighed any given piece of evidence, FDA did not ignore, misrepresent, distort, dismiss or favor evidence merely because it supported a particular result.

(Comment 6) A comment argues that FDA dismisses evidence supporting the benefits of ESDs for SIB or AB because of various weaknesses yet accepts evidence of risks that may have the same weaknesses.

(Response) FDA disagrees. FDA considered all available data and information, derived from a variety of sources and methods. As discussed in Responses 5 and 7, because the strength of different data and information—for example, from the scientific literature, experts, and various stakeholders—varied greatly, we weighed the evidence accordingly. Although the commenter may disagree with how FDA weighed the evidence, we did not dismiss evidence.

With respect to accepting evidence of risks from sources that exhibit weaknesses, we explain throughout this rulemaking that we believe AEs have been underreported and the reasons why (see Responses 26 to 28). Information submitted to FDA after the proposal supports that proposition and has helped us, upon further consideration, to update our evaluation. For example, as explained in Response 13, we believe the proposed rule understated the risk and harm of pain. We believe that the risk of pain is greater and that the harm of pain is more frequent than stated in the proposed rule.

In other cases, we explain that we evaluated particular risks consistent with our view of the weight of evidence. For example, we explain in Response 24 that the risk of seizures is not well established, in part because the information came from individuals who attributed their seizures to ESDs, lay people, as well as advocacy groups that stated shocks could trigger seizures (as opposed to,
e.g.,
peer-reviewed scientific articles). Because we did not accord this information significant weight, it did not greatly affect our evaluation of the benefit-risk profile.

As another example, the commenter argues that we have identified the risk of suicidality based on anecdotes from individuals who were subject to ESDs and that suicidality was not related specifically to ESD application. The comment highlights an individual who experienced suicidal ideation yet later credited use of the ESD for saving her life by replacing what the commenter describes as “ineffective and harmful psychotropic medication.” To support this risk of ESDs for SIB or AB, we explained in the proposed rule that experts in the field of behavioral science (including members of the Panel) and State agencies that regulate ESDs indicate that the devices have been

associated with short- and long-term trauma, including suicidal ideation (81 FR 24386 at 24399). Given that ESDs can also contribute to stress, anxiety, learned helplessness, and posttraumatic reactions, among other outcomes, we do not believe that it is reasonable to conclude that the risks presented by ESDs are unrelated to suicidal ideation.

The individual's belief that an ESD helped her does not speak to whether suicidal ideation is a risk posed by the device. FDA has no reason to doubt that she experienced suicidal ideation or that it stopped and she felt better. However, her statement is not strong evidence for the effects of ESDs on the processes underlying the ideation; the statement is not offered by an expert in the field and is not a result from a clinical study under controlled conditions. Such a statement, for example, does not rule out the possibility that concurrent therapies were responsible for the improvement, nor does it necessarily represent any other individual's point of view. It also does not provide any basis for concluding that state-of-the-art therapies, properly attempted and continuously administered, would not have succeeded.

In another instance, the comment criticizes FDA for using a double standard when presenting and evaluating data by quoting an expert in a media report who explained that an individual went into a catatonic condition after an ESD was used on him. However, this was one of multiple sources FDA relied on for this risk. We explained that catatonia may be an additional risk based on scientific literature that describes catatonic sit-down associated with the use of ESDs, and statements and comments from individuals on whom ESDs have been used, their family members, disability rights groups, and others. Because the statement appeared in a media report, we did we not accord it the same weight as the information in the scientific literature.

It is also important to understand that the premise of the critique—that the same type of evidence should support establishing benefits if it supports identifying risks—is flawed. For example, FDA has long recognized that isolated case reports, random experience, reports lacking sufficient details to permit scientific evaluation, and unsubstantiated opinions are not regarded as valid scientific evidence to show safety or effectiveness, but that such information may be considered, however, in identifying a device the safety and effectiveness of which is questionable (see 21 CFR 860.7(c)(2)). The same general principle applies here. While the evidence purporting to show the benefits of ESDs for SIB or AB is insufficient to establish the effectiveness of the device, the same type of evidence may provide useful risk information. For example, an isolated case report that describes an initial increase in self-mutilative behavior following ESD application indicates to FDA that an initial increase in self-mutilative behavior is a risk even though the same report would not meet the threshold of evidence to establish effectiveness. This does not mean that any type or amount of evidence is sufficient to support a risk of harm; it means only that certain evidence that may be inadequate to establish effectiveness may nonetheless be adequate to support certain risks.

(Comment 7) A comment states that, in FDA's Executive Summary for the Panel Meeting, we noted that the majority of behavioral studies identified prior to the Panel Meeting were confined to small sample sizes or case reports. The comment asserts that those limitations have not stopped FDA from relying on literature about positive behavioral support (PBS), while FDA dismisses evidence supportive of ESDs because of those same limitations.

(Response) FDA disagrees. The comment incorrectly attributes a description from the Executive Summary to materials that FDA identified after the Panel Meeting. Since the Panel Meeting, FDA identified additional information and data, including behavioral studies with larger numbers of subjects. Additionally, as explained elsewhere, although the commenter may disagree with how FDA weighed the evidence, FDA did not dismiss evidence due to small sample sizes or the fact that they were case reports. However, these factors did result in FDA assigning relatively less weight than we would to a more robust design such as a randomized controlled trial with a large number of subjects.

With respect to the evidence supportive of ESDs, the only article specifically about JRC's GED device was published in a peer-reviewed journal over a decade ago, and it studied only nine subjects at JRC (Ref. 7). Studies of ESDs more generally have been published in peer-reviewed journals, but many of them are decades old. In the intervening decades, the understanding of pathophysiology has evolved as has the ability to identify and systematically record AEs. These developments are alongside heightened peer-review standards for study and reporting. Accordingly, it is reasonable to assign these studies less weight than more modern studies.

Since the Panel Meeting, FDA identified several studies of PBS in peer-reviewed journals that include more subjects, systematically record AEs, and benefit from recent (not decades-old) knowledge. For example, a recent single meta-analysis of PBS that FDA identified after the Panel Meeting synthesized information from 423 case reports (Ref. 8), whereas JRC has stated in a comment that it only applied its GED to 269 individuals since 1990. The peer-reviewed data and information about PBS were published more recently and better reflect modern scientific advances and contemporary ethical standards of the profession. The evidence also adheres to modern, more exacting peer-review standards for study conduct and reporting. Recent studies also benefit from the improvements in functional analysis and teaching adaptive or replacement behaviors that began in the mid-1980s (see Ref. 9). Refinement and application of such knowledge increases the success of the behavioral interventions (see Ref. 10). Further, more-modern study designs that include more coded baseline and treatment data points correlate with clearer demonstrations of treatment effects (see Ref. 10). Another benefit is that relatively recent studies of behavioral treatment of SIB more often report results that are generalizable across settings (see Ref. 11). Modern study designs are also more reflective of contemporary ethics and practice, making their results more relevant to treatment (see Ref. 12, discussing outmoded nomenclature and setting to study the effects of contingent shock on body rocking). It is noteworthy that even recent meta-analyses that included punishment techniques did not include the use of ESDs (see,
e.g.,
Ref. 10); one Panel member described the modern attitude toward ESDs for SIB or AB as “wholesale abandonment.” To summarize the advantages of more-recent data, the quality and quantity of the available data tend to be higher, they tend to show clearer effects, and the corresponding refinement in techniques leads to greater treatment success.

Therefore, although some PBS studies rely on small sample sizes or are case reports, the overall number of subjects who have been studied is significantly larger than for ESDs for SIB or AB. More robust analysis has been conducted on these subjects, and the data and information are more recent, more reflective of scientific advances and modern ethical standards, and held to a higher peer-review standard. Thus, we believe we have appropriately weighed the evidence and disagree that we

should have considered the various studies to be of equivalent weight.

(Comment 8) A comment criticizes the 2006 New York State Education Department (NYSED) report on JRC as misleading and biased and questions FDA's reliance on the report. The comment points to an earlier NYSED report from 9 months prior that was more favorable to JRC.

(Response) FDA disagrees that the report is misleading and biased. As the 2006 report states, the NYSED undertook a review based on documentation it received subsequent to its 2005 inspections (Ref. 22). That documentation, according to NYSED, “raised concern about JRC's use of aversive interventions, as well as recent questions from legislators.” The 2005 Special Education Quality Assurance Nondistrict Program Review, the earlier NYSED report, was more general, focusing on “areas of greatest significance to the health and safety and provision of special education programs and services.” In contrast, the 2006 Observations and Findings of Out-of-State Program Visitation was specifically conceived “to gain an understanding of the scope of the behavior intervention plans,” paying particular attention to: (1) Health and safety issues related to the use of aversive interventions; (2) the general standard for implementing and monitoring behavior plans; (3) whether the interventions were commensurate with the individuals' behavioral difficulties; and (4) to determine if individuals were receiving interventions consistent with individualized education programs.

Although the 2005 Program Review and the 2006 Observations and Findings both examine practices at JRC, their scope and purpose are separate and distinct. Further, the 2005 document contemplated all students from New York, whereas the 2006 document considered those whose behavioral intervention plans included the use of ESDs. Thus, to the extent these documents shed light on the use of ESDs for SIB or AB, the 2006 document is more relevant than the 2005 document.

To provide context, the NYSED has itself submitted a docket comment consistent with their 2006 report (Ref. 23). Specifically, regarding the necessity of ESDs, the NYSED 2006 report relied in part on three behavioral psychologists serving as independent consultants. The NYSED in 2006 also conducted interviews with individuals at JRC. FDA believes it reasonable to give more weight to the 2006 report because, unlike the 2005 report, its objective was to examine the use of ESDs for SIB or AB, and it included evaluations from independent behavioral psychologists as well as the results of patient interviews.

(Comment 9) A comment asserts that, because FDA did not visit JRC and meet with its staff or obtain firsthand observations of residents, we did not educate ourselves on the complete facts regarding JRC's use of the device. The comment contrasts this with what it characterizes as ex parte discussions with other parties, including three former residents who approached FDA.

(Response) While FDA did not directly observe residents in JRC's facility, it did not need to do so to obtain relevant information for this rulemaking. Such observations are not necessary for FDA to understand JRC's use of ESDs or, more importantly, the risks and benefits of ESDs for SIB or AB. Such observations would not be part of a trial or study, nor would they proceed according to experimental controls that could allow observers or analysts to draw generalizable conclusions. Any observation may or may not be typical, whether by chance or, for example, because a tour at JRC's invitation would be controlled or the areas and individuals available for observation would not be representative. Elsewhere, this commenter criticizes the incorporation of anecdotal data and information; information obtained by FDA on such a tour would likely be subject to the same criticism.

Further, we have information about the residents at JRC and their views, including firsthand accounts. JRC has provided FDA with pictures and short biographies of many JRC residents. It has also provided copies of emails expressing individuals' sentiments that are favorable to JRC. During the Panel Meeting, individuals at JRC, including representatives of JRC, presented their views. FDA also conducted inspections of JRC.

While FDA had discussions with three former residents prior to issuing the proposed rule, to the extent we relied on these communications, we summarized the relevant content and provided our rationale in the proposed rule. The public had an opportunity to review this information and comment on it.

(Comment 10) A comment asserts that phone interviews conducted by FDA with individuals formerly at JRC were anecdotal and unscientific, yet the comment also claims that FDA dismissed clinical data from JRC and did not interview patients and parents who support the use of ESDs for SIB or AB. The commenter also states that FDA did not consider data from 269 individuals at JRC since 1990 and argues that such data plainly demonstrate the effects of ESDs on SIB and AB.

(Response) FDA disagrees that we dismissed any data, either clinical data from JRC or the views of individuals at JRC and parents who support the use of ESDs for SIB or AB. We explained in the proposed rule and elsewhere in this final rule how this evidence relates to our conclusions and the strength of the evidence as it pertains to those conclusions. We considered all commenters' stated opinions and weighed them appropriately when drawing scientific conclusions. FDA considered all data and information, including anecdotal evidence relating to the individuals and families with current or former experience with JRC's use of ESDs for SIB or AB. However, we agree with the commenter that anecdotal evidence should not be accorded the same weight as scientific evidence, and we weighed such evidence accordingly. Obtaining views from all perspectives, including highly personal information, proved helpful in understanding perspectives on the use of ESDs.

Although FDA did not conduct interviews with individuals currently at JRC or their parents, they have had the opportunity to submit comments in the context of the Panel Meeting and proposed rule. Two associations of family members of individuals at JRC submitted comments to the Panel Meeting docket opposing a ban (one of the comments included 32 letters from family members). At the Panel Meeting, one parent and three individuals at JRC spoke in opposition to the ban. In the docket for the proposed rule, we received a brief from JRC parents' counsel, letters through counsel from parents of individuals at JRC, as well as other individual comments opposing the ban, primarily from those associated with JRC. Additionally, a comment alluded to an editorial in a national newspaper and included copies of emails apparently meant to convey that individuals formerly at JRC are grateful for their time at JRC.

Furthermore, although the commenter may disagree with how FDA weighed the evidence, FDA did not dismiss clinical data from the manufacturer (see Response 26; see also Responses 18, 38, and 39, discussing other records). As explained elsewhere, we believe the available data and information, including that from the manufacturer, JRC, underreport AEs (see Responses 26 to 28). Noting such omissions or weaknesses in the data and information

is not to dismiss it but rather to explain why it does not necessarily show what the commenter argues, much less show as much conclusively. Likewise, as explained in Responses 33, 34, 38, and 39, we found that because of the multitude of flaws and weaknesses, the data and information provided by JRC do not establish durable effectiveness. For instance, the data do not represent
study
data but rather only resident records; the data and information fail to adequately detail behaviors prior to ESD use, formal functional assessments, important aspects of device application and data collection; and the data fail to account for effects from concurrent treatments. We disagree that we did not consider this data, and upon consideration, find the data do not demonstrate the effectiveness of ESDs for SIB or AB.

(Comment 11) A comment asserts that parent- and patient-centric perspectives deserve more weight than unnamed parents' perspectives reported to researchers who used pseudonyms for publication. The commenter prefers “parents who communicated on the record, direct and unfiltered.”

(Response) FDA disagrees. The fact that a researcher does not identify parents by name does not make those parents' perspectives less relevant or useful. FDA notes that the same comment elsewhere states that FDA should discount certain parent- and patient-centric perspectives that disagree with the commenter, even when those parents and patients used their names and submitted their perspectives for the record. Further, the comment does not explain why the fact that a researcher does not identify an individual impacts reliability. Nevertheless, when we discussed the opinions of unnamed parents in the proposed rule, we noted that we could not conclude that the experiences reported by those who volunteered to share negative experiences were shared by others or are generally representative of families' experiences with JRC. We have weighed the perspectives with these considerations in mind.

(Comment 12) A comment criticizes FDA for relying on unsourced letters and papers and unscientific news articles with quotes from lay people.

(Response) As explained elsewhere, FDA considered opinions from experts and lay people, and we took into account whether opinions were offered by experts or supported by research, among other factors. Opinions offered by behavioral experts about the treatment of SIB and AB are afforded more weight than laypeople's opinions about the treatment of SIB and AB; those expert opinions carry yet more weight when, for example, they cite peer-reviewed research. Regarding sourcing, since all of the references that the comment critiques as unsourced were attributed to specific authors and institutions, FDA fails to understand this criticism. Additionally, the sourcing provided FDA with the information needed to determine the weight to give each reference. Each reference was available for review during the comment period, so the commenter had an opportunity to comment on their substance.

In terms of weighing the evidence from the references the commenter cites, we recognize, for example, that Dr. Donnellan wrote a letter that was not peer-reviewed. However, because Dr. Donnellan has expertise in the field, the content of the letter merits more weight than laypeople's opinions. So too does the chapter authored by Drs. LaVigna, Willis, and Donnellan because of the authors' expertise in the subject matter. Moreover, a named editor reviewed the information, which merits additional weight compared to unedited documents, even those from experts. Regarding the report from NYSED, FDA believes that agency's responsibility and expertise to assess such information, as well as draw conclusions from that information, is relevant in determining how much weight to give the report.

With respect to the news article referred to by the commenter, FDA cited it solely with respect to our assessment of the state of the art, to support the fact that one of the pioneers of ESDs publicly repudiated contingent shock for a lack of effectiveness, and not as part of our determination that the evidence fails to establish ESD effectiveness. We believe it is appropriate to cite this type of source for this limited point. Further, FDA notes that the commenter elsewhere implores FDA to heed views presented in a newspaper, including speculation by Dr. Israel, in an attempt to make a point regarding ESD effectiveness and the lack of effectiveness of alternatives (Ref. 13). In that case, the commenter relies on the newspaper article to make conclusory claims about the negative effects of removing ESDs. Even putting aside the relative weakness of this source, the newspaper article makes clear that the individual's treatment plan consisted of many elements in addition to ESDs, and that the individual subject to shocks increasingly “could not accept the price of this improvement,” the improvement being an average of fewer than 200 shocks per month in connection with decreased self-mutilation. We do not agree with the commenter's criticisms and elsewhere explain how we weighed various types of information differently.

C. Risks of ESDs for SIB or AB

(Comment 13) A comment argues that FDA's evaluation of the benefit-risk profile of ESD use is fundamentally flawed because the risks did not materialize into harms. The comment also argues that FDA failed to account for the risks posed by banning the device, which the comment characterizes as a “life-saving therapy.”

(Response) FDA disagrees that we have overstated risks and have not accurately evaluated the benefit-risk profile in consideration of those risks. Risks do not need to have materialized into harms to be relevant because proof of harm is not required under the banning standard. Further, some of the risks posed by ESDs have materialized into harm, including intense pain. The commenter itself recognizes that there are potential risks associated with use of ESDs. It refers to a consent form listing some of the risks, which are consistent with FDA's analysis in the proposed rule:

The potential physical risks associated with the GED may include temporary skin redness, which clears up within a few minutes or a few days at most, and there is a possibility that a small blister may appear. JRC rotates the placement of the electrodes to avoid superficial red marks or scaling of the skin. The psychological/behavioral risks that might be associated with the GED include anxiety (nervousness, tensing muscles) during the period between the occurrence of the behavior and the occurrence of the programmed consequence, escape responses and short-term or long-term collateral effects including: nightmares; intrusive thoughts; avoidance behaviors; marked startle responses; mistrust; depression; flashbacks of panic and rage; anger; hyper-vigilance; and insensitivity to fatigue or pain.

The form adds to the evidence in the proposed rule, among other information, that the shock “is intended to function as a painful stimulus.” In the proposed rule, although we provided, for example, descriptions of individuals who experienced ESDs describing the shock as “a thousand bees stinging you in the same place for a few seconds,” we also noted information from JRC suggesting that the electric current may not be great enough to cause pain and its statements that the shock “may be” painful to some patients (81 FR 24386 at 24397). Since then, behavioral experts testified in the Massachusetts hearing regarding the level of pain caused by ESDs based on their personal experience with ESD shocks. For example, they testified the shocks felt “excruciatingly painful,” “extremely painful,” “quite

painful,” like a “bulging and a ruptured disc,” and “the most painful thing I've ever experienced.” (Ref. 14, respectively: day 7 at 161; day 9 at 82; day 21 at 81-82; day 13 at 218.) In light of this new information from JRC and the experts in the Massachusetts hearing, we believe that the proposed rule understated pain as a harm caused by ESDs.

The pain ESDs cause is relevant because, although ESDs are intended to apply an aversive stimulus, the pain they cause to develop the aversion is nevertheless harmful. We also noted that JRC does not include pain in its discussion of AEs caused by the device, yet when JRC's Dr. Nathan Blenkush was asked directly whether the stimulus causes pain, he answered “yes” (81 FR 24386 at 24397; see also Ref. 15 at 123). People affiliated with JRC, including Drs. Edward Sassaman and Anthony Joseph, have stated that they observed no harms in many years of observing individuals subject to ESDs, so they appear not to consider certain adverse effects, including pain, to be harms. As stated in the proposed rule, such a view is in line with decades-old research that considered pain or discomfort to be an indicator of effectiveness (81 FR 24386 at 24397). However, this is not consistent with contemporary standards, and we conclude that pain caused by the devices is a harm. Far from overstating risks because they have not materialized into harms, FDA believes that JRC has understated realized harms, and the proposed rule understated at least the degree of harm of pain.

With regard to the risks of the ban itself, FDA has considered the risks of the use of ESDs for SIB or AB in light of the state of the art for SIB and AB and determined that they are substantial and unreasonable. In contrast, as discussed in section V.E, state-of-the-art therapies such as PBS pose little to no risk and are generally successful regardless of the severity of the target behavior. FDA acknowledges that a small subpopulation of people who manifest SIB or AB may simply have no adequate treatment option. However, this does not mean that ESDs are effective for that subpopulation or that such individuals would be harmed if ESDs were not available. Claims that the use of ESDs is necessary for some people are not supported by the available data and information.

(Comment 14) A comment asserts, while recognizing that pain has a subjective element, that the shock delivered by an ESD is not capable of physical harm to the patient, such as skin burns or other damage to the body or impairment of any bodily functions. The comment asserts that FDA's clearance of the GED-1 included review of data on pain perception levels submitted by JRC.

(Response) FDA agrees that pain has a subjective element, but disagrees with the suggestions that pain is not a physical harm, or a harm at all. As we explained in the proposed rule, although physical reactions roughly correlate with the peak current, shock intensity and its effects can also vary from person to person based on the amount of sweat on the skin, electrode placement, recent history of shocks, and body chemistry, among other factors (81 FR 24386 at 24387). Further, adverse psychological reactions are even more loosely correlated with shock intensity (see 81 FR 24386 at 24387). As such, the intensity and subjective experience will vary, including the degree to which the shock poses a risk of harm to the individual. For this reason, as discussed here and in Response 18, the subjectivity of the pain and variability of the shock intensity elevate FDA's concern regarding the risk of pain and other harms in that they make it difficult to predict the impact that a particular shock will have on a particular individual at a particular time.

Several Panel members expressed concerns regarding the difficulties and lack of understanding regarding dosing (shock intensity) and variability in individual pain thresholds from both safety and effectiveness standpoints (see,
e.g.,
Ref. 15 at 50, 89, 137, 296, 302, 326, 349). Further, although all ESDs covered by this ban present the risk of pain, some ESDs, such as JRC's GED-4, which delivers more than triple the maximum electrical current of the GED-1, present an even higher risk of pain than others. The increased current means the device is likely to cause more pain than lower current ESDs notwithstanding the element of subjectivity in the experience of pain. In addition, this physical pain may lead to psychological trauma, discussed further in Response 18.

FDA acknowledges that, in 1994, FDA found an earlier model of one of JRC's GED devices substantially equivalent to predicate aversive conditioning devices. Regardless of what data JRC may have submitted at that time or how FDA evaluated it for substantial equivalence to predicate devices in the context of a 510(k)—
i.e.,
a premarket notification submission under section 510(k) of the FD&C Act (21 U.S.C. 360(k))—we are not bound by such in a banning proceeding under section 516 of the FD&C Act. To ban a device, we consider all available data and information. The past 25 years since the clearance of that GED have yielded valuable data, analyses, and experience with ESDs for SIB or AB, as well as advancements in science and medicine. These data and information have improved our understanding of the risks posed by this type of device, including the risk of pain, as well as the diagnosis of, and treatment options for, patients that exhibit SIB or AB.

As for other physical harms, FDA disagrees that the shock strength of ESDs is not capable of producing other physical harms. In our analysis of physical risks in the proposed rule, we explained that the literature contains reports of tissue damage that ranged from burns to bruises. As discussed further in the next comment response, the literature is supported by evidence contained in numerous comments to the docket, including those from NYSED, the U.S. Department of Justice, and a former employee of JRC. Other risks that FDA identified in the scientific literature include increased frequency or bursts of self-injury and errant shocks from device misapplication or failure. In addition, FDA considered risks identified through other sources, which provide further support for the physical risks reported in the literature and indicate that ESDs are associated with additional physical risks of neuropathy and (potentially less seriously) injuries from falling (see Ref. 15 at 312, summarizing additions to list of risks).

In sum, although pain has an element of subjectivity, pain correlates roughly with the maximum electrical current output by the device. The device is intended to cause pain and is capable of causing other physical injuries under certain conditions. However, the variability of those conditions as well as the subjective element in the experience of pain make it difficult to minimize the risks of any given shock or series of shocks. Experts on the Panel echoed these concerns.

(Comment 15) One comment specifically objects to FDA's characterization of six references reporting on tissue damage or burns.

(Response) FDA has reviewed the references and agrees that two do not support the original analysis of tissue damage and burns, and we have determined that the literature cited does not by itself establish the risk of tissue damage or skin burns attributable to the use of ESDs. However, the other references together with other sources do support these risks, as we explain in the following paragraphs. Further, based on the new analysis, FDA's ultimate conclusion that the risk presented by

the device is unreasonable and substantial did not change.

We stated in the proposed rule that the literature contains many reports of tissue damage or burns from ESDs and cited several references to that effect. However, one reference that we cited did not report tissue damage or burns, and it stated that “there was little to suggest the development of adverse side-effects” (Ref. 16). Considering the study was conducted in 1975 and did not systematically observe or record AEs, and given that it studied only two subjects, the change to our evaluation of the benefit-risk profile is minimal. It does not affect our overall conclusion with respect to the substantial and unreasonable risks.

Another reference that we cited for the risk of tissue damage, Ref. 17, did not report tissue damage as a direct result of individual shocks applied to the skin. Instead, the reference discusses the possibility that individuals may, after extended device application, manifest SIB that eventually results in tissue damage. Although we no longer consider this reference to support the risks of skin burns or tissue damage as a direct result of ESD use, given the multiple other references that support these risks, FDA continues to find that a risk of using ESDs is skin burns or tissue damage. In our re-evaluation, we note that this source did not systematically observe and record AEs, that its conclusion about effectiveness was tentative (“might be”), and that it had a small sample size (eight individuals) with high variability. As such, the re-evaluation does not change our overall conclusion with respect to the substantial and unreasonable risks of ESDs.

The comment also criticizes FDA's characterization of Ref. 18 as providing a report of burns to the single individual it studied. The comment notes that the device was not intended for human use and that its replacement, a device intended for human use, did not cause burns because the electrodes were placed directly on the skin. Although placing electrodes directly on the skin would reduce the likelihood of electrical arcing and the risk of skin burns from arcing, this does not eliminate the risk of burns more generally; in the proposed rule, we did not attribute the risk of burns solely to electrical arcing. As we stated in the proposed rule, Dr. James Eason, a biomedical engineer, opined that ESDs intended for human use, such as the SIBIS, GED-1, and GED-4, are capable of causing superficial skin burns under certain circumstances (81 FR 24386 at 24396). Similarly, a member of the Panel noted that a 20-milliamps shock can cause a first-degree burn (Ref. 15 at 140). Further, the type of device that is banned could include technology in which the electrodes are not placed on the skin and arcing occurs. Thus, whether the electrodes are attached directly to the skin or not, we continue to believe burns or other tissue damage are risks posed by ESDs for SIB or AB.

The comment also takes issue with FDA's interpretation of Ref. 19, stating that reddened areas occurred from wearing the device and not from the shocks themselves. FDA considers reddened areas from device use to be evidence of tissue damage, although FDA considers Ref. 19 to be evidence of a minor harm. During an exchange at the Panel Meeting, some question arose over whether such damage is erythema or a first-degree burn (see Ref. 15 at 140). A representative of JRC explained that he did not know but had been told by dermatologists that it was erythema (see Ref. 15 at 141). However, he later added “[w]ell, that depends on your definition. Is this a burn or not?” and again referred to dermatologists' statements (Ref. 15 at 141). FDA interprets these statements to mean that some injury to the skin, although it may be minor, has occurred from use of the device, and we believe that referring to such an injury as “tissue damage,” as we did in the proposed rule, is accurate.

Similarly, the comment emphasizes that the tissue damage from a SIBIS reported in Ref. 20 resembled a bruise rather than a burn. According to the reference, this mark lasted about a week before it disappeared. The comment also presents a quotation from Ref. 7 that the use of GEDs resulted only in “an occasional temporary discoloration of the surface of the skin that cleared up within a few minutes or a few days.” As before, regardless of whether the bruise-like mark and discolorations which could last for days were burns or bruises, we consider both to be tissue damage and described them accurately in the proposed rule as temporary. As such, FDA continues to identify tissue damage or skin burns as risks.

The risk of tissue damage or skin burns is supported by additional sources. As discussed in the proposed rule, FDA reviewed complaints made to the Massachusetts Disabled Persons Protection Committee related to the use of ESDs for SIB or AB (Ref. 21, incident #49037). In 2007, the Massachusetts Department of Early Education and Care (DEEC) conducted an investigation of JRC's Stoughton Residence, where ESDs were used (Ref. 21). According to the Investigation Report, an individual reported waking up because his roommate was screaming; his roommate had been asleep but was shocked by a GED, waking him and causing him to scream. JRC staff reported that “the skin was off of the area” of the leg where GED shocks had been applied, that the GED was removed from the leg “because the area . . . was too bad to keep the device,” and either the individual who received the shocks or the staff believed a stage 2 ulcer had developed (Ref. 21).

In addition, the NYSED conducted an onsite review of JRC's behavior intervention program and “witnessed staff rotating GED electrodes on individuals' bodies at regular intervals to `prevent burns that may result from repeated application of the shock to the same contact point.' ” (See Ref. 22, summarized in the proposed rule, 81 FR 24386 at 24397.) Further, NYSED, in a comment submitted to the Panel Meeting, stated that they “received numerous reports of students who have incurred physical injuries (burns, reddened marks on their skin) as a result of being shocked,” (Ref. 23). NYSED reviewers also noted that school nurses monitor the individuals' skin for burns (Ref. 22).

We also have reports of burns from individuals formerly at JRC as well as their parents. At the Panel Meeting, one such parent described burns their child acquired from ESD applications (Ref. 15 at 203). The individuals who were interviewed by FDA staff shared their negative experiences at JRC and similarly reported burns that they attributed to the use of ESDs (see Ref. 15 at 62-63, summarizing experiences). In sum, the literature, Panel Meeting proceedings, NYSED report, and individual anecdotal reports support the conclusion that ESDs present the risk of tissue damage, including skin burns.

(Comment 16) Commenters point out instances in the proposed rule in which FDA misattributed or misstated information from certain sources regarding certain risks.

(Response) FDA has reviewed the references, and we acknowledge some misattributions and misstatements.

We have revised our analysis as follows:

(a) We stated that one risk is the intensification of an undesirable behavior known as self-restraint. We attributed this information, in part, to Ref. 24; however, this reference does not provide support for the stated observation. Nonetheless, we cited another reference for this observation, and FDA continues to regard the intensification of self-restraint as a risk from the use of ESDs for SIB or AB (Ref. 17).

(b) We stated that an adverse outcome from ESD use for SIB or AB is the manifestation of napkin-tearing, an undesirable behavior. However, upon review, we do not regard napkin-tearing as an adverse outcome. Because the risk to self and others from napkin-tearing is minimal, the removal of this adverse outcome from our evaluation of the benefit-risk profile is of little consequence and does not affect the overall conclusion with respect to the substantial and unreasonable risks of illness or injury from the use of ESDs for SIB or AB.

(c) We stated that an adverse outcome from ESD use for SIB or AB is an increase in affection seeking. However, the study indicates that affection seeking replaced “pathological behaviors,” meaning affection seeking was a relatively desirable effect (Ref. 25). This affects our evaluation of the benefit-risk profile in that it updates an incorrectly identified risk to be a potential benefit, meaning the profile is slightly more favorable than previously appreciated. However, considering the small magnitude of this change, and that this study was conducted in 1965 and did not systematically observe or record AEs, this change does not affect our overall conclusion with respect to the substantial and unreasonable risks.

(d) We stated that, except for the harms described elsewhere in the proposed rule, JRC maintains that it “has not found any side effects associated with aversive conditioning” and “there are no confirmed reports or confirmed medical evidence that patients have any negative psychological side effects related to any discomfort experienced due to therapy with the proper use of the GED devices.” JRC has clarified that the full sentence reads: “JRC has not found any side effects associated with aversive conditioning except the occasional discoloration of the skin that disappears within an hour to a few days and some brief, temporary anxiety just prior to the delivery of the application.” Because we included all of the information in this sentence elsewhere in the proposed rule, this does not affect our evaluation of the benefit-risk profile or our overall conclusion with respect to the substantial and unreasonable risks.

(Comment 17) Some comments question the validity of FDA's attribution of certain risks of implantable cardioverter defibrillators (ICDs) to ESDs. One such comment argues that risks must be considered based on the intended patient population and the purposes of the device, and there is no basis for attributing the risks of ICDs to ESDs for SIB or AB. The comment also notes that the scientific literature does not compare ESDs for SIB or AB to ICDs.

(Response) FDA agrees that the differences between ESDs and ICDs, including intended uses, prevent FDA from drawing meaningful conclusions from ICDs about the risks of ESDs. In the proposed rule, we expressly observed that the devices have drastically different intended uses, patient populations, benefit-risk profiles, and states of the art of treatments for the intended patient populations. Upon further consideration, with stakeholder input, we have determined that comparison of these devices is not enlightening for the purposes of this final rule and have updated our assessment of the risk profile of ESDs accordingly.

Despite this update, FDA has determined that risks of illness or injury posed by the use of ESDs for SIB or AB are substantial and unreasonable. In the proposed rule, FDA used the comparison with ICDs to support the risks of posttraumatic reactions, up to and including PTSD, based on the pain and corresponding distress of potential future shocks. FDA made a comparison on the basis that each device delivers an electric shock to an individual that is out of the individual's control, occurs multiple times, and is generally perceived as surprising and painful or unpleasant. As such, our comparison was narrow, limited to the particulars of such a stimulus, and yielded additional support for observations already made based on consideration of ESDs themselves. The removal of the narrow comparison from our assessment therefore does not remove the basis for identifying such risks even though it removes some support based on a device type comparison.

With regard to ESDs (considered on their own), FDA identified distress of potential future shocks in particular as a trauma that people subject to ESDs may experience, meaning that the ongoing application of ESDs compounds the risk. Although we are no longer drawing support from the narrow comparison to ICDs for this premise, we have elsewhere explained our further consideration of the evidence supporting posttraumatic reactions, up to and including PTSD. Comments to the docket supported that people subject to ESDs experience this trauma. To summarize very briefly, further consideration of that data and information has bolstered our conclusion that the repeated application of a painful stimulus such as that from an ESD, in particular when it is not within the recipient's control, contributes to and escalates the risk of developing acute and/or chronic posttraumatic reactions. (See Response 18 for more detail.) Thus, we believe the evidence for the risks of such reactions is as strong as that discussed in the proposed rule.

Further, as explained in Response 13 and elsewhere, we believe that the proposed rule understated the harm of pain. As JRC acknowledges, the shock from an ESD is intended to be painful, and the scientific literature and statements from individuals who were subject to ESDs (as well as others who have tested ESDs on themselves) indicate that the pain from such shocks is severe, and it causes distress and fear. We believe that this evidence bolsters our previous findings and suggests the pain from the device is a reasonable basis to find support for distress of future shocks from ESDs, potentially leading to posttraumatic reactions (see Response 18).

In sum, upon further consideration, we have removed the narrow comparison to ICDs from our assessment of risks, but information and data from other sources confirms and bolsters the risks of posttraumatic reactions, up to and including PTSD, based on the pain and corresponding distress of potential future shocks. As such, our overall conclusion has not changed with regard to the substantial and unreasonable risks of ESDs used for SIB or AB.

(Comment 18) A comment questions whether references support FDA's statements about psychological trauma, namely that: (1) When the recipient does not have control over the shocks and has previously received multiple such shocks, psychological trauma such as an anxiety or panic reaction can result even when the strength is relatively modest (see Ref. 26) and (2) a series of less traumatic events can cause the development of stress disorders such as PTSD (see Ref. 27; see also Ref. 26). The comment takes issue with FDA's interpretation of the references, particularly regarding current diagnostic criteria for PTSD, the nature of a Criterion A event (one of the diagnostic criteria in DSM-5), and the evidence regarding a dose-response relationship between traumatic events and manifestations of PTSD.

(Response) FDA disagrees. As discussed in Response 13, based on information submitted in comments, FDA believes it understated the harm of pain in the proposed rule. For example, one clinician, Dr. Edwin Mikkelsen, testified in the Massachusetts hearing that the shock was excruciatingly painful and should not be used on humans, that it was unconscionable,

and that it prompted the doctor to resign from the Level III certification team (Ref. 14, day 7 at 161-63, 193-94). Another clinician, Dr. James McCracken, stated that “[t]his shock is intense. It is not a simple tickle or a buzz. It is frightening.” (Ref. 14, day 9 at 158.) The doctor went on to describe it as extremely painful, causing involuntary movement, and that it raised very strong ethical concerns (Ref. 14, day 9 at 82, 86). Yet another clinician, Dr. Jeffrey Geller, described the shocks as quite painful, “worse than a bee sting,” “much worse than a hard pinch,” and like a “bulging and a ruptured disc,” causing “writhing gyrations” (Ref. 14, day 21 at 81-83). Dr. Jennifer Zarcone, another clinician, described the shocks as “very painful, and I got very upset. It's probably the most painful thing I've ever experienced.” (Ref. 14, day 13 at 217-18). In short, FDA does not believe that the pain from the shocks from ESDs currently in use is actually modest for the individuals subject to them. The intensity of pain from the shocks suggests that individuals are more likely to experience trauma that may lead to psychological symptoms.

Further, as discussed in the paragraphs that follow, regardless of how a single shock is perceived by a particular shock recipient, FDA believes that a series of shocks can be traumatic to the individual and give rise to psychological harms, including anxiety, stress reactions, learned helplessness, acute stress disorder, and even PTSD. When the recipient does not have control over the shocks and has previously received multiple such shocks, the risk may be yet greater, especially in that learned helplessness may be more likely. Finally, the vulnerability of this patient population and the circumstances of the event, including the interpersonal nature of the trauma, the ongoing nature of the shocks, and the fact that the device is attached to the recipient's body, may further increase the risk of psychological harms.

The Diagnostic and Statistical Manual of Mental Disorders (DSM) includes diagnostic criteria for PTSD; Criterion A regards the stressor event to which an individual is exposed. The current edition, DSM-5, originally published in 2013, incorporates a broader definition of a Criterion A event than previous editions: The person must be exposed to death, threatened death, actual or threatened serious injury, or threatened sexual violence through direct exposure, witnessing the trauma, learning that a relative or close friend was exposed to a trauma, or indirect exposure to aversive details, usually in the course of professional duties.

In criticizing FDA's explanation, the comment has apparently misunderstood both FDA's statements and the previously cited references with respect to how the diagnostic criteria for PTSD have evolved, and the comment mischaracterizes the necessity of a single Criterion A event and the literature's findings. The criteria have evolved such that a diagnosis of PTSD may be based on a series of events rather than a single, discrete event. Even before the DSM update, the literature had found that people exhibited the symptoms of PTSD even when a single, discrete event did not appear to cause the symptoms. The explanation of the revised diagnostic criteria, from the DSM-IV to the DSM-5, makes clear that PTSD may develop from threatened (not only actual) harm or from a series of traumatic events (not only a single, discrete event).

Thus, shocks that individually may appear modestly stressful to an observer could constitute a Criterion A stressor under the DSM-5 when multiple such shocks are administered, even though they may not have met Criterion A under prior iterations of the DSM. This is especially true when the recipient is experiencing additional vulnerabilities or circumstances discussed later in this response (
e.g.,
the interpersonal nature of the shock delivery, the attachment of the device serving as a constant threat of future shocks). This change in Criterion A relates to the argument in Ref. 26, that the previous version of Criterion A, which contemplated a single, discrete, highly traumatic event, did not in fact serve its intended gatekeeper function and was not a useful criterion because people still manifested the symptoms of PTSD without such an event as it was then defined. The revisions to the diagnostic Criterion A for PTSD were intended to bolster its effectiveness as a gatekeeper criterion by more comprehensively capturing the kinds of events that can result in PTSD symptomatology. Thus, although the commenter states that Ref. 26 “comes to opposite conclusions,” the conclusions of Ref. 26 and the parallel evolution of the DSM clearly support FDA's determination that a series of traumatic events, even those events that may appear modestly stressful to observers, can give rise to stress disorders, including PTSD.

Turning to the issue of dose response, as the comment points out, Ref. 26 empirically reviews evidence and ultimately questions the then-current paradigm for diagnosing PTSD, based on what the reference calls “core assumptions,” including that PTSD has a specific etiology and that the severity of the trauma has a strong dose-response relationship to the severity of PTSD. The authors review the evidence regarding each of these assumptions and conclude that the assumptions did not adequately account for the manifestation of many cases of PTSD, implying that the assumptions were wrong in some way.

We agree with the commenter and the authors that the dose-response relationship between the severity of the trauma and the stress disorder is weak, meaning that the severity of the symptoms or resulting disorder may not correspond with the severity of the trauma. The authors also find that people exhibited the full symptomatology of PTSD even if the trauma that caused the symptoms did not satisfy the then-current (pre-DSM-5) Criterion A. While the comment agrees with these authors and FDA that there is a weak or nonexistent dose-response relationship, it misunderstands the implication of this, which is that severe symptoms may manifest even if the trauma is not severe.

In an apparent attempt to alleviate concerns relating to psychological risks from a painful shock, the commenter elsewhere states that electrical stimulation is easily measured objectively, and implies that a psychologically harmless level can be set. First, as discussed earlier, due to the complexity of the interactions between different output settings (
e.g.,
pulse width, frequency, electrode size) and inter-individual variability in shock perception, it is difficult to define a cutoff stimulation for pain or trauma. The Panel understood this and was very concerned about the impact this variability could have. Most importantly, individuals who are subject to ESDs are repeatedly exposed to a painful stimulus, and several individuals have expressed that they were anxious and/or fearful about future shocks. Further, because the dose-response relationship between a trauma and the severity of resulting psychological symptoms is weak, it would be even more difficult to use electrical parameters to predict whether any eventual psychological symptoms will be mild or nonexistent, and FDA is unaware of data demonstrating such. (See also FDA's discussion in the proposed rule about how an individual's perception of the trauma is not reliably predicted by the electrical parameters, 81 FR 24386 at 24393-24394.) Regardless of the ability to draw such a line, the GED devices currently in use pose all of the physical and

psychological risks discussed in this rule.

The comment also apparently misunderstands FDA's reference to an article that in turn refers to an earlier edition of the DSM. The DSM-III-R, originally published in 1987, specified that the person must have witnessed or experienced a serious threat to life or physical well-being, but the current DSM-5 contemplates a wider spectrum of events that may be traumatic and other, more indirect ways to experience traumatic events, thereby broadening Criterion A. Specifically, the current version of Criterion A in the DSM-5 also allows for “threatened” traumas, meaning that the event has not actually occurred. Not only does an ESD patient experience the trauma of a severe pain, which can be a Criterion A event, but the device is attached to the patient's body, constantly threatening additional trauma. FDA's reference to the article helps to illustrate the evolution of the diagnostic criteria and supports the risk of developing PTSD symptoms. In short, a contemporary understanding of trauma associated with PTSD or its symptomatology supports that these are risks of receiving shocks from the devices.

Indeed, this commenter elsewhere quotes the American Psychiatric Association (APA), the publisher of the DSM, which explicitly compared the DSM-5 to the DSM-IV: “Compared to DSM-IV, the diagnostic criteria for DSM-5 draw a clearer line when detailing what constitutes a traumatic event. Sexual assault is specifically included, for example, as is a recurring exposure that could apply to police officers or first responders” (Ref. 28). The APA has explained that the current diagnostic criteria now accommodate trauma stemming from repetition, and the criteria now focus more on the symptoms the individual displays rather than describing the individual's subjective response to a given event. Criterion A also includes witnessing a trauma. Thus, even an individual who witnesses another receive an ESD shock is potentially at risk for developing acute stress disorder or PTSD from the experience, particularly if the witness has been sensitized by the experience of having received an ESD shock themselves. Indeed, Panel members expressed great concern about the impact on staff of using this device (see Ref. 15 at 310); this concern is heightened for individuals subject to ESDs who witness traumas of others.

The literature, including Ref. 26, discusses additional factors in the development of PTSD symptoms, such as individual vulnerabilities and resilience, and the literature distinguishes the manifestation of anxiety or stress from the development of a disorder in light of such characteristics. Psychological traumas, regardless of whether the results are characterized and diagnosed as PTSD, are more likely for vulnerable individuals, depend on the circumstances of the event, and can be more severe without effective emotional support afterward (see Ref. 26). In the case of ESDs, the individuals subject to them are generally more vulnerable because of their cognitive impairments and, in many cases, comorbid conditions. Many individuals subject to ESDs have an impaired ability to associate cause and effect, which, as we noted in the proposed rule, increases the risk of psychological harms (see 81 FR 24386 at 24395). Such vulnerable individuals are particularly susceptible to the risk of learned helplessness. Despite this, JRC does not monitor for or assess PTSD or other stress disorder symptomatology according to its records, meaning individuals are less likely to receive adequate emotional support.

While the commenter did not specifically address the portion of FDA's statement regarding the lack of control over multiple shocks, this is an additional risk factor. The risk of psychological trauma may be greater when the recipient does not have control over the shocks and has previously received multiple shocks, because learned helplessness may be more likely. An individual's inability to control receiving an aversive stimulus such as a shock from an ESD is often linked to learned helplessness (see,
e.g.,
Ref. 15 at 311, summarizing mentions of learned helplessness). Further, device malfunctions and staff's inappropriate delivery of shocks result in many noncontingent shocks being received (Ref. 15 at 59 (summarizing 53 filed complaints), 310 (concerning JRC staff)). As a Panel member stated, “there are multiple episodes of non-contingent infliction, including malfunction of the device.” (Ref. 15 at 310.) The risk of psychological harm increases if the shocks are delivered noncontingently or if the individual subject to the ESD is unable to understand that the shock is related to undesirable behavior. Panel members explained that this is the perfect paradigm for learned helplessness (Ref. 15 at 304).

We note that, in addition to the relationship among vulnerabilities, noncontingent delivery of shocks and psychological risks, noncontingent delivery also undermines the effectiveness of the punishment paradigm for ESDs. ESDs are intended to accomplish behavior modification through punishment. This depends on consistent, contingent delivery of shocks. Correspondingly, it also depends on the ability of the individual to associate cause and effect,
i.e.,
recognize the contingency. If shocks are delivered noncontingently, or the individual does not perceive the contingency, the treatment paradigm and potential effectiveness of the device are undermined.

Further, circumstances surrounding the application of shocks may amplify the harms. In particular, the DSM-5 states that PTSD “may be especially severe or long-lasting when the stressor is interpersonal and intentional (
e.g.,
torture, sexual violence),” (Ref. 29 at 274). An ESD shock is interpersonal because it comes from a person the recipient identifies as a caregiver, the shock is intentional because the monitor must activate the device, and the shocks occur repeatedly over a long period of time. Repeated ESD shocks, because of their interpersonal nature, may therefore precipitate especially severe or long-lasting symptoms.

Based on other evidence discussed in the proposed rule and received in comment responses, ESD use can be linked with DSM-5 criteria for PTSD, most clearly including Criterion A, Criterion B intrusion symptoms (intrusive distressing memories), Criterion C symptoms (persistent avoidance of stimuli associated with the traumatic event), and Criterion D symptoms (negative alterations in cognition and mood). While there are eight criteria in the DSM-5 that need to be met for a diagnosis of PTSD in a particular patient, the evidence in the record corresponding with some of these criteria is sufficient for FDA to conclude that ESDs for SIB or AB pose a risk of developing PTSD; actual occurrence of a particular harm is not necessary for FDA to determine a device presents a risk of that harm. Further, lack of information regarding some of the criteria may be due to poor recordkeeping, clinical oversight, and training of personnel at JRC to identify safety and effectiveness outcomes.

In addition to being part of a diagnosis of PTSD, the PTSD symptoms for which we have evidence are also harms on their own. For example, FDA has evidence that recipients of ESD shocks have experienced nightmares, flashbacks, avoidance, startle, hypervigilance and reexperiencing symptoms, and even the JRC training manual indicates that the following symptoms of PTSD should be monitored for: nightmares, flashbacks, avoidance,

startle, and hypervigilance. One patient reported nightmares, flashbacks, and re-experiencing symptoms as a result of the ESD administration (Ref. 15 at 63). The Panel discussed that various symptoms of PTSD, including nightmares, flashbacks, emotional distress, and intrusive thoughts, were found in individuals who have been subject to ESD shocks, although no systematic psychiatric assessment using DSM criteria was conducted for PTSD (see Ref. 15 at 154, summarizing such symptoms in people subject to ESDs). Additionally, of 53 complaints filed from 1993-2013 regarding ESD with the Massachusetts Disabled Persons Protection Committee (DPPC) that FDA reviewed, negative emotional reactions and PTSD were reported as AEs (Ref. 15 at 59). From 2010 to 2013, FDA officials were contacted by, and met with, representatives from various national disability organizations. These organizations reported at least four case reports of psychological trauma and PTSD symptoms, and stressed that alternative treatments, such as positive environmental and reinforcement strategies, have been developed and are generally successful for severe and refractory self-injury (see Ref. 5 at 72; see also Ref. 15 at 59).

If shock recipients develop PTSD symptoms, they may be more severely impacted by future shocks because they could have “heightened sensitivity to potential threats, including ones that are related to the traumatic experience” (Ref. 30 at 275). “Symptom recurrence and intensification may occur in response to reminders of the original trauma, ongoing life stressors, or newly experienced traumatic events” (Ref. 30 at 277). Reminders of past shocks, for example, seeing the staff member(s) who administered the shocks or seeing others suffering the same trauma, may contribute to re-traumatization. Significantly, the ESD itself remains attached to the individual's body, presenting a near-constant reminder of past trauma, so FDA believes there is a meaningful potential for re-traumatization subsequent to painful and traumatic stimuli such as the shocks delivered by ESDs. The testimony during the Massachusetts hearing reflected such concerns. Dr. McCracken emphasized the heightened risk of trauma from exposing a member of a vulnerable patient population to continual, painful shocks over a period of years, in many cases several years (Ref. 14, day 9 at 158-59).

FDA's review of JRC's records did not find evidence that JRC monitors for or asks about PTSD, including assessment of the cardinal symptoms of PTSD. Given the literature, the testimony about ESDs specifically, and the fact that JRC does not monitor for such harms, FDA disagrees with JRC's assertions that ESDs would not cause PTSD or PTSD symptoms, among other psychological harms. In short, the evidence indicates that shocks from an ESD can cause PTSD or several of its symptoms, and once the symptoms arise, recipients may be even more susceptible to harms from future shocks.

In sum, the literature on PTSD has evolved to recognize situations like the repeated use of ESDs, where a series of events together may be traumatic enough for some individuals to develop posttraumatic reactions, including acute stress disorder, PTSD symptomatology, and PTSD. As we explained in the proposed rule, psychological risks also include anxiety, panic reactions, learned helplessness, and other stress disorders (see,
e.g.,
81 FR 24386 at 24393 to 24394). Manifestations of these harms may contribute to a PTSD diagnosis, but they are also harms on their own. Individuals subject to ESDs for SIB or AB also have vulnerabilities that tend to increase the risks of experiencing psychological harms. Based on the literature, modern diagnostic criteria, and expert opinion, FDA has determined that ESDs used for SIB or AB pose the risk of causing those psychological harms.

(Comment 19) One comment states that the pseudocatatonic sitdown reported in one article and described as an adverse event by FDA was an act of self-restraint and was an improvement over previous behaviors.

(Response) FDA disagrees with the comment. Entrance into a pseudocatatonic state is a risk posed by the use of ESDs. The authors of the reference proposed that the pseudocatatonic behavior was a self-protective response to avoid punishment: They “surmised that this global muscular `freezing' or `melting' provided `insurance' for the patient, preventing her from striking out and consequently being punished for doing so” (Ref. 31). The patient became temporarily unresponsive, even upon receiving affection from caregivers. Thus, even assuming the authors were correct that the pseudocatatonic state was “insurance” against striking out, this does not mean that the behavior was not an adverse effect or risk. Particularly in the case of certain aggressive, non-self-injurious behavior, this change in behavior is not necessarily an improvement for the patient. Replacing aggressive behaviors such as curses, threats, or striking out against others with a lack of all responsiveness is not necessarily an improvement in the patient's wellbeing. Indeed, a Panel member made clear that generalized behavior suppression is a risk and occurs,
i.e.,
“when experiencing a great deal of punishment, some people just stop behaving in general” (Ref. 15 at 305; see also id. at 312). This is also concerning because less-invasive behavioral techniques such as those that are within the state of the art would not provoke responses such as a pseudocatatonic state. FDA is not persuaded that more acceptable behavior from an outsider's perspective equates to improved wellbeing for the patient. FDA continues to regard generalized behavioral suppression, such as pseudocatatonic reactions, as a risk of ESDs used for SIB or AB.

(Comment 20) One comment states that crying decreased after use of aversives in one instance where FDA claims that crying increased, citing Ref. 32.

(Response) FDA disagrees. Although Ref. 32 reports decreased crying during one phase of the study involving contingent shock, crying increased in the final treatment phase, which also involved contingent shock (Ref. 32 at 621). In addition, other studies report crying as an AE from ESDs for SIB or AB, including increases in crying during later sessions (see,
e.g.,
Ref. 33 at 117). Because crying, which can be indicative of trauma, did in fact increase in the cited reference as well as other references, FDA continues to consider increased crying as an AE associated with the use of ESDs for SIB or AB.

(Comment 21) One comment claims FDA incorrectly cites Ref. 34 to support the risk that ESDs cause temporary or long-term increases in symptoms and frequency of SIB. The comment alleges that this is a “complete misstatement” because in fact the authors reported a decrease in target behaviors to zero.

(Response) Regarding a temporary or long-term increase in symptoms, FDA disagrees. While the article cited states that “[h]owever by the fifth day of Phase 1 treatment, self-mutilative behaviors were reduced to zero, and emotionality had returned to pretreatment levels,” the article concludes by noting that the subject had “become more incontinent during waking hours since termination of the treatment program” (Ref. 34). Moreover, the subject's initial reaction “was an increase in emotionality and in frequency of self-mutilative behaviors” (Ref. 34). Accordingly, FDA believes the commenter is incorrect.

(Comment 22) One comment argues that FDA misrepresented the findings of Ref. 35 regarding the risk of undesirable

replacement behavior, given the statement in the article: “Our experience suggests that once most SIB has been eliminated, especially if it was deliberately replaced by new, desirable behaviors, favorable qualitative changes often took place in the behavior of the patients.”

(Response) FDA disagrees. Although the article does state that favorable changes
often
took place in the patients “
once
most SIB had been eliminated, especially
if
it was deliberately replaced by desirable behaviors,” (Ref. 35, emphasis added), this does not mean favorable changes usually or always took place, or that most SIB was often or usually eliminated, or, most importantly, that it was often or usually replaced by desirable behaviors. Indeed, the article explains that, at one of the study sites where skin shock was used, the positive effects were temporary, and SIB returned if shocks were delivered by a different staff member or in a different room (Ref. 35). The authors observed, “[o]ccasionally, when one type of SIB is reduced, another would appear in its place,” and, given the likelihood of reinforcement of negative behaviors, “the probability that a replacement behavior will be undesirable is quite high” (Ref. 35).

In addition, one of the commenter's own references states that positive behaviors that were not the targeted behavior can be modified during treatment (Ref. 36). This information supports FDA's statement regarding undesirable replacement behavior as a risk posed by ESDs for SIB or AB.

(Comment 23) One comment states that FDA misrepresented references reporting hostility and retaliation as adverse events. The commenter views hostility and retaliation as part of those patients' preexisting behavioral history.

(Response) Upon further consideration, FDA believes that additional context will help inform the likelihood of the risk of hostility and retaliation. In Refs. 29 and 31, the patients' hostility and aggression were part of the patients' clinical presentation. In Ref. 29, the researchers state “it is difficult to know whether [the patient's] infrequent attacks represent retaliation for the punishment,”
i.e.,
retaliation for the aversive stimulus used to reduce AB. Nevertheless, “viewed against the long history of this kind of behavior” and “the long period of time (containing many positive reinforcements) between the infrequent aversive stimuli and the assaultive incidents,” they doubt the aversive stimulus provoked retaliation. Thus, the researchers considered hostility and retaliation hypothetical risks of the use of aversive stimuli but deemed the risks doubtful in light of additional information.

FDA cited Ref. 31 to support similar risks, specifically surrogate retaliation, threats, and warning

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2020-04328. Public record. Not legal advice.