Federal Register / Vol. 83, No. 246 / Wednesday, December 26, 2018 / Rules and Regulations 66103 

1ECT devices with intended uses outside the 

scope of those listed in paragraphs 21 CFR 

882.5940(b)(1) and (2) are considered 

postamendments device, that are subject to 

classification under section 513(f)(1) of the FD&C 

Act or, if the relevant requirements are met, under 

section 513(f)(2) of the FD&C Act. 

practice that do not substantially affect 

the rights or obligations of non-agency 

parties. 

The rule does not contain any 

information collection requirements 

subject to the provisions of the 

Paperwork Reduction Act (44 U.S.C. 

3501 et seq.). 

PART 220—PROCESS FOR 

CONSIDERATION OF PETITIONS FOR 

DUTY SUSPENSIONS AND 

REDUCTIONS 

■ Accordingly, the interim rule that was 

published at 81 FR 67144 on September 

30, 2016, is adopted as a final rule 

without change. 

By order of the Commission. 

Lisa Barton, 

Secretary to the Commission. 

[FR Doc. 2018–27768 Filed 12–21–18; 8:45 am] 

BILLING CODE 7020–02–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 882 

[Docket No. FDA–2014–N–1210] 

Neurological Devices; Reclassification 

of Electroconvulsive Therapy Devices; 

Effective Date of Requirement for 

Premarket Approval for 

Electroconvulsive Therapy Devices for 

Certain Specified Intended Uses 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing a final 

order to reclassify the electroconvulsive 

therapy (ECT) device for use in treating 

catatonia or a severe major depressive 

episode (MDE) associated with major 

depressive disorder (MDD) or bipolar 

disorder (BPD) in patients age 13 years 

and older who are treatment-resistant or 

who require a rapid response due to the 

severity of their psychiatric or medical 

condition, which is a preamendments 

class III device, into class II (special 

controls). FDA is also issuing this final 

order to require the filing of a premarket 

approval application (PMA) or a notice 

of completion of a product development 

protocol (PDP) for the preamendments 

class III ECT devices for all other uses 

that are not being reclassified to class II 

(product code GXC). 

DATES: This order is effective on 

December 26, 2018. See further 

discussion in section V, Implementation 

Strategy. 

FOR FURTHER INFORMATION CONTACT: 

Carlos Pen ̃ a, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2680, Silver Spring, 

MD 20993, 301–796–6610, carlos.pena@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Table of Abbreviations/Commonly Used 

Acronyms in This Document 

II. Background 

A. Reclassification 

B. Requirement for Premarket Approval 

C. Valid Scientific Evidence 

III. Public Comments in Responding to the 

Proposed Order 

A. Comments in Support of Reclassifying 

ECT Into Class II 

B. Comments on Reclassifying ECT Based 

on Safety and Effectiveness 

C. Comments on Patient Concerns 

D. Comments on Regulatory Process of the 

Proposed Order 

E. Comments on Labeling Concerns 

F. Comments Outside the Scope of This 

Final Order 

IV. The Final Order 

V. Implementation Strategy 

A. Date To File a PMA 

B. Compliance With Special Controls 

VI. Codification of Orders 

VII. Analysis of Environmental Impact 

VIII. Paperwork Reduction Act of 1995 

IX. References 

I. Table of Abbreviations/Commonly 

Used Acronyms in This Document 

TABLE OF ABBREVIATIONS AND

ACRONYMS

Abbreviation 

or acronym What it means 

510(k) .......... Premarket Notification. 

2011 Panel .. 2011 Neurological Devices Panel 

Meeting. 

AACAP ........ American Academy of Child and Adolescent Psychiatry. 

APA ............. American Psychiatric Association. 

BPD ............. Bipolar Disorder. 

CANTAB ...... Cambridge Neuropsychological Test 

Automated Battery. 

CFR ............. Code of Federal Regulations. 

CGI–I ........... Clinical Global Impressions-Improvement scale. 

ECT ............. Electroconvulsive Therapy Device. 

FDA ............. Food and Drug Administration. 

FDARA ........ FDA Reauthorization Act of 2017. 

FDASIA ....... Food and Drug Administration Safety 

and Innovation Act. 

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

Act. 

FR ................ Federal Register. 

IDE .............. Investigational Device Exemption. 

MAUDE ....... Manufacturer and User Facility Device Experience. 

MDD ............ Major Depressive Disorder. 

MDE ............ Major Depressive Episode. 

MDR ............ Medical Device Reporting. 

M–ECT ........ Maintenance ECT. 

MMSE .......... Mini Mental State Exam. 

OMB ............ Office of Management and Budget. 

PDP ............. Product Development Protocol. 

PMA ............. Premarket Approval Application. 

PRA ............. Paperwork Reduction Act of 1995. 

Ref ............... Reference 

TABLE OF ABBREVIATIONS AND

ACRONYMS—Continued 

Abbreviation 

or acronym What it means 

RWD ............ Real-World Data. 

RWE ............ Real-World Evidence. 

SE ................ Safety and Effectiveness. 

U.S.C. .......... United States Code. 

WFSBP ........ World Federation of Societies of Biological Psychiatry. 

II. Background 

The Federal Food, Drug, and Cosmetic 

Act (FD&C Act), establishes a 

comprehensive system for the regulation 

of medical devices intended for human 

use. Section 513 of the FD&C Act (21 

U.S.C. 360c) established three categories 

(classes) of devices, reflecting the 

regulatory controls needed to provide 

reasonable assurance of their safety and 

effectiveness (SE). The three categories 

of devices are class I (general controls), 

class II (special controls), and class III 

(premarket approval). 

Under section 513(d) of the FD&C Act, 

devices that were in commercial 

distribution before the enactment of the 

1976 amendments, May 28, 1976 

(generally referred to as preamendments 

devices) are classified after FDA has: (1) 

Received a recommendation from a 

device classification panel (an FDA 

advisory committee); (2) published the 

panel’s recommendation for comment, 

along with a proposed regulation 

classifying the device; and (3) published 

a final regulation classifying the device. 

FDA has classified most 

preamendments devices under these 

procedures. 

Devices that were not in commercial 

distribution prior to May 28, 1976 

(generally referred to as 

postamendments devices) 1 are 

automatically classified by section 

513(f) of the FD&C Act into class III 

without any FDA rulemaking process. 

Those devices remain in class III and 

require premarket approval unless, and 

until, the device is reclassified into class 

I or II or FDA issues an order finding the 

device to be substantially equivalent, in 

accordance with section 513(i) of the 

FD&C Act, to a predicate device that 

does not require premarket approval. 

The Agency determines whether new 

devices are substantially equivalent to 

predicate devices by means of 

premarket notification procedures in 

section 510(k) of the FD&C Act (21 


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U.S.C. 360(k)) and part 807 (21 CFR part 

807). 

A preamendments device that has 

been classified into class III and devices 

found substantially equivalent by means 

of premarket notification (510(k)) 

procedures to such a preamendments 

device or to a device within that type 

(both the preamendments and 

substantially equivalent devices are 

referred to as preamendments class III 

devices) may be marketed without 

submission of a PMA until FDA issues 

a final order under section 515(b) of the 

FD&C Act (21 U.S.C. 360e(b)) requiring 

premarket approval. 

On August 18, 2017, section 513(f) of 

the FD&C Act was amended by the FDA 

Reauthorization Act of 2017 (FDARA; 

Pub. L. 115–52). Under section 513(f)(6) 

of the FD&C Act, FDA has authority to 

issue an administrative order classifying 

an accessory based on the risks of the 

accessory when used as intended and 

the level of regulatory controls 

necessary to provide a reasonable 

assurance of SE of the accessory, 

notwithstanding the classification of 

any other device with which such 

accessory is intended to be used. FDA’s 

‘‘Medical Device Accessories— 

Describing Accessories and 

Classification Pathways’’ guidance 

describes the statutory mechanisms to 

request: (1) Classification for accessories 

that have been granted marketing 

authorization as part of a PMA, 

premarket notification (510(k)), or De 

Novo request for another device with 

which the accessory involved is 

intended to be used and (2) 

classification for accessories included in 

a PMA or 510(k) that FDA has not 

classified distinctly from another device 

under the FD&C Act (Ref. 1). 

A. Reclassification 

Under section 515(i)(2) of the FD&C 

Act, following publication of a proposed 

order, a meeting of a device 

classification panel, and consideration 

of the comments of a proposed order, 

FDA has the authority to issue an 

administrative order revising the 

classification of a device that FDA has 

classified as a class III device and for 

which no administrative order has been 

issued calling for PMAs under section 

515(b) of the FD&C Act, so that the 

device is classified into class I or II. In 

determining whether to revise the 

classification of a device or to require a 

device to remain in class III, FDA 

applies the criteria set forth in section 

513(a) of the FD&C Act. Section 

513(a)(1)(B) of the FD&C Act defines 

class II devices as those devices for 

which the general controls in section 

513(a)(1)(A) by themselves are 

insufficient to provide reasonable 

assurance of SE, but for which there is 

sufficient information to establish 

special controls to provide a reasonable 

assurance of SE of a device. 

FDA published a proposed order in 

the Federal Register of December 29, 

2015 (80 FR 81223), held a meeting of 

a device classification panel on January 

27–28, 2011, as described in section 

513(b) of the FD&C Act with respect to 

ECT devices, and considered comments 

from public dockets, and, therefore, has 

met the requirements under sections 

515(i)(2) of the FD&C Act. 

B. Requirement for Premarket Approval 

Section 515(b)(1) of the FD&C Act sets 

forth the process for issuing a final order 

requiring PMAs. Specifically, prior to 

the issuance of a final order requiring 

premarket approval for a 

preamendments class III device, the 

following must occur: (1) Publication of 

a proposed order in the Federal 

Register; (2) a meeting of a device 

classification panel described in section 

513(b) of the FD&C Act; and (3) 

consideration of comments from all 

affected stakeholders. As noted above, 

FDA has published a proposed order 

that would require PMAs for an 

electroconvulsive therapy device for 

certain uses other than a severe MDE 

associated with MDD or BPD, in the 

Federal Register of December 29, 2015. 

FDA has held a meeting of a device 

classification panel described in section 

513(b) of the FD&C Act with respect to 

ECT devices. Finally, FDA has received 

and has considered over 3,400 

comments on the proposed order, as 

discussed in section II. Therefore, FDA 

has met the requirements under section 

515(b)(1) of the FD&C Act. 

On July 9, 2012, the Food and Drug 

Administration Safety and Innovation 

Act (FDASIA) (Pub. L. 112–144) was 

enacted. Section 608(a) and (b) of 

FDASIA amended section 515(b) of the 

FD&C Act, changing the mechanism for 

requiring premarket approval for a 

preamendments device from rulemaking 

to an administrative order. 

Although under the FD&C Act a 

manufacturer of a class III 

preamendments device may respond to 

the call for PMAs by filing a PMA or a 

notice of completion of a PDP, in 

practice, the option of filing a notice of 

completion of a PDP has not been used. 

While corresponding requirements for 

PDPs remain available to manufacturers 

in response to a final order under 

section 515(b) of the FD&C Act, for 

simplicity this document will refer only 

to the requirement for the filing and 

receiving approval of a PMA. 

Under section 501(f) of the FD&C Act 

(21 U.S.C. 351(f)), a preamendments 

class III device may be commercially 

distributed without a PMA until 90 days 

after FDA issues a final order (or a final 

rule issued under section 515(b) of the 

FD&C Act prior to the enactment of 

FDASIA) requiring premarket approval 

for the device, or 30 months after final 

classification of the device under 

section 513 of the FD&C Act, whichever 

is later. Because ECT devices were 

classified in 1979, the 30-month period 

has expired (44 FR 51776, September 4, 

1979), and the later of these two time 

periods is the 90-day period. Therefore, 

if a PMA is not filed for ECT devices for 

certain specified intended uses within 

90 days after the issuance of a final 

order, the device will be deemed 

adulterated under section 501(f) of the 

FD&C Act. 

Also, a preamendments device subject 

to the order process under section 

515(b) of the FD&C Act is not required 

to have an approved investigational 

device exemption (IDE) (see part 812 (21 

CFR part 812)) contemporaneous with 

its interstate distribution until the date 

identified by FDA in the final order 

requiring the filing of a PMA for the 

device. At that time, an IDE is required 

only if a PMA has not been filed. If the 

manufacturer, importer, or other 

sponsor of the device submits an IDE 

application and FDA approves it, the 

device may be distributed for 

investigational use. If a PMA is not filed 

within 90 days after the issuance of a 

final order, and the device is not 

distributed for investigational use under 

an IDE, the device is deemed to be 

adulterated within the meaning of 

section 501(f)(1)(A) of the FD&C Act, 

and subject to seizure and 

condemnation under section 304 of the 

FD&C Act (21 U.S.C. 334) if its 

distribution continues. Other 

enforcement actions include, but are not 

limited to, the following: Shipment of 

devices in interstate commerce will be 

subject to injunction under section 302 

of the FD&C Act (21 U.S.C. 332), and the 

individuals responsible for such 

shipment will be subject to prosecution 

under section 303 of the FD&C Act (21 

U.S.C. 333). FDA requests that 

manufacturers take action to prevent the 

further use of devices for which no PMA 

has been filed. 

C. Valid Scientific Evidence 

The evidentiary standard FDA relies 

on to determine the SE of a device is 

valid scientific evidence. Section 

860.7(c)(2) (21 CFR 860.7(c)(2)) defines 

valid scientific evidence. As described 

in section III, in finalizing this order, 

FDA has assessed the totality of the 


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valid scientific evidence that was 

provided in response to the proposed 

order, including several comments that 

referenced additional clinical studies. 

Several of these studies included SE 

data for adult as well as adolescent 

patients. FDA also considered 

randomized controlled clinical studies, 

open-label observational trials, case 

series reports, systematic literature 

reviews, and practice guidelines that 

were submitted in the comments. Single 

case reports or opinion-based 

commentary were also submitted to the 

dockets for consideration; however, 

without well controlled empirical 

experimentation, these types of 

information are generally not 

considered valid scientific evidence and 

were not relied upon to support this 

reclassification. 

FDA received many comments from 

healthcare professionals describing their 

practices, the length of time they have 

been practicing, and the utilization of 

ECT devices in treating patients with 

certain conditions. While FDA 

acknowledges receiving comments in 

support of the proposed reclassification, 

statements by individual healthcare 

professionals that they have used ECT 

devices to treat individual patients do 

not constitute valid scientific evidence 

to demonstrate reasonable assurance of 

SE (see valid scientific evidence 

discussion in 48 FR 56778 at 56786– 

56788, comments 16–21, December 23, 

1983, Ref. 2). Such comments do not 

contain sufficient detail to capture the 

use of the device, exposures, and 

outcomes in the appropriate population 

and are not interpretable using informed 

clinical and scientific judgement. 

FDA also received many comments 

from patients, or friends and family of 

patients, in support and against 

reclassification of ECT devices. These 

comments described the experience of 

the patient that received treatment from 

an ECT device. FDA acknowledges 

receiving comments from patients and 

other individuals about their experience 

with the device being considered for 

reclassification; however, FDA does not 

consider such comments to be valid 

scientific evidence. Because these 

comments did not contain sufficient 

detail to capture the use of the device, 

exposures, and outcomes in the 

appropriate population and are not 

interpretable using informed clinical 

and scientific judgement, such 

comments are not considered valid 

scientific evidence. 

For medical devices, available 

evidence is traditionally comprised of 

clinical and non-clinical studies 

conducted and provided to FDA by the 

device manufacturer or sponsor. 

However, FDA recognizes that a wealth 

of data covering medical device 

experience is routinely collected in the 

course of treatment and management of 

patients. Under certain circumstances, 

these real-world data (RWD) may 

constitute real-world evidence (RWE), 

or clinical evidence regarding the usage 

and potential benefits or risks of a 

medical product derived from analysis 

of RWD, that may be of sufficient 

quality to help inform or augment FDA’s 

understanding of the benefit-risk profile 

of devices at various points in their life 

cycle, and could potentially be valid 

scientific evidence used to aid FDA in 

regulatory decision making. See FDA’s 

guidance, ‘‘Use of Real-World Evidence 

to Support Regulatory Decision-Making 

for Medical Devices’’ (82 FR 41418, 

August 31, 2017, Ref. 3), which clarifies 

how FDA evaluates RWD to determine 

whether it may be sufficiently relevant 

and reliable to generate the types of 

RWE that can be used in FDA regulatory 

decision making for medical devices, 

including potentially generating valid 

scientific evidence. 

In identifying a device, the SE of 

which is questionable, § 860.7(c)(2) also 

explains random experience and reports 

lacking sufficient details to permit 

scientific evaluation may be considered 

valid scientific evidence. Such random 

experience and reports lacking 

sufficient details to permit scientific 

evaluation may be early and sometimes 

informal indications of the danger or 

ineffectiveness of a device (43 FR 32988 

at 32990, July 28, 1978). Where FDA is 

considering the classification of a 

device, such random experience and 

reports are not considered valid 

scientific evidence. 

III. Public Comments in Response to the 

Proposed Order 

On December 29, 2015, FDA 

published a proposed order to reclassify 

from class III to class II the ECT device 

for use in treating a severe MDE 

associated with MDD or BPD in patients 

18 years of age and older who are 

treatment-resistant or who require a 

rapid response due to the severity of 

their psychiatric or medical condition 

and to require the filing of a PMA for 

ECT devices for the intended uses of 

schizophrenia, bipolar manic states, 

schizoaffective disorder, 

schizophreniform disorder, and 

catatonia. The comment period on the 

proposed order closed on March 28, 

2016. 

In response to the December 29, 2015, 

proposed order, FDA received over 

3,400 comments from industry, 

professional societies, trade 

organizations, and individual 

consumers by the close of the comment 

period, each containing one or more 

comments on one or more issues. We 

describe and respond to the comments 

in this section of the document. The 

over 3,400 comments are grouped based 

on the common themes listed below. We 

have grouped similar comments 

together under the same number and 

numbered them sequentially. 

A. Comments in Support of 

Reclassifying ECT Into Class II 

(Comments 1–2) 

B. Comments on Reclassifying ECT 

Based on Safety and Effectiveness 

(Comments 3–9) 

C. Comments on Patient Concerns 

(Comments 10–16) 

D. Comments on Regulatory Process of 

the Proposed Order (Comments 17– 

23) 

E. Comments on Labeling Concerns 

(Comments 24–29) 

F. Comments Outside the Scope of This 

Final Order (Comments 30–34) 

Please note that in some cases we 

separated different issues discussed by 

the same commenter and designated 

them as distinct comments for purposes 

of our responses. The number assigned 

to each group is purely for 

organizational purposes and does not 

signify the comment’s value or 

importance or the order in which 

comments were received. 

In the proposed order we asked 

interested persons to submit comments 

on two specific questions. FDA sought 

comments on whether: (1) The term 

‘‘treatment resistant’’ and the phrase 

‘‘require rapid response’’ provide 

sufficient clarity to the population for 

which ECT benefits outweigh risks and 

(2) if 60 days is an appropriate time to 

allow existing manufacturers who do 

not intend to market their ECT device(s) 

for uses other than use in treating severe 

MDE associated with MDD and BPD in 

patients 18 years of age and older who 

are treatment-resistant or who require a 

rapid response due to the severity of 

their psychiatric or medical condition to 

prepare and submit 510(k) amendments 

for ECT devices. FDA continues to 

believe the term ‘‘treatment resistant’’ 

and the phrase ‘‘require rapid response’’ 

provide sufficient clarity to the 

population for which ECT benefits 

outweigh risks. Because there were no 

comments submitted on the second 

question, FDA’s discussion of when 

510(k) holders should submit an 

amendment to a 510(k) is in section 

V.B., Compliance with Special Controls, 

of this final order. 


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A. Comments in Support of 

Reclassifying ECT Into Class II 

(Comment 1) FDA received many 

comments generally supporting the 

proposed reclassification to class II. 

Comments included many literature 

references including references 

published since the 2011 Neurological 

Devices Classification Panel meeting 

(the 2011 Panel). Several comments 

noted that ECT had been used safely 

and effectively in their practice or on 

themselves as a patient or on a family 

member or a friend. 

(Response 1) After examination of the 

totality of the scientific evidence, FDA 

continues to believe that there is 

sufficient evidence to establish special 

controls that, together with general 

controls, provide a reasonable assurance 

of SE to reclassify ECT to class II for use 

in treating a severe MDE associated with 

MDD or BPD, as initially specified in 

the proposed order. In addition, FDA 

has determined that there is adequate 

support for the reclassification of ECT 

into class II for the treatment of 

catatonia and expanding the adolescent 

age subpopulation from 18 to 13 years 

of age. FDA has made this 

determination based upon a 

reassessment of the following sources of 

information: (1) Published literature 

referenced in the Executive Summary to 

the 2011 Panel; (2) comments and 

literature received in public dockets 

including the call for SE information for 

all preamendments class III devices (74 

FR 16214, April 9, 2009), the call for 

ECT SE information in a separate docket 

(74 FR 46607, September 10, 2009), the 

2011 Panel (75 FR 72832, November 26, 

2010), the ECT Draft Guidance (80 FR 

81330, December 29, 2015) and the 

proposed order (December 29, 2015) 

(these five dockets are to be referred to 

as ‘‘ECT public dockets’’ in this 

document, discussed below in response 

2); (3) clinical practice guidelines; and 

(4) review of medical device reports 

(MDRs) in the FDA Manufacturer and 

User Facility Device Experience 

(MAUDE) database. The reevaluation of 

the scientific evidence presented to and 

discussed at the 2011 Panel meeting, 

and the review of additional post-2011 

scientific information that was provided 

to FDA in comments to the proposed 

order, further supports this finding. 

(Comment 2) Several comments 

supported the reclassification of ECT to 

class II for a severe MDE associated with 

MDD or BPD, but said the 

reclassification was too restrictive in its 

scope. Several additional indications, 

many of which are outside the scope of 

this classification effort, were 

mentioned. Comments suggested that 

classification should be expanded to 

some or all of the following indications 

and populations (ordered 

alphabetically): 

• Adolescents 

• Adolescents and children 

• Autism 

• Catatonia 

• Delirium 

• Delusional disorders 

• Developmental disability 

• Maintenance or continuation ECT 

• Mania in BPD 

• Mania—refractory, intractable, acute 

• Neuroleptic malignant syndrome 

• Other psychiatric disorders and 

conditions for which ECT has been 

used 

• Parkinson’s disease 

• Patients with contraindications to 

drug treatment including women who 

are pregnant/nursing, the elderly, or 

those who have comorbid conditions 

• Psychosis—treatment resistant, 

puerperal 

• Schizophrenia—clozapine resistant, 

refractory 

• Schizoaffective disorder 

• Severe self-injurious behavior 

• Shy-Drager syndrome 

• Status epilepticus 

• Suicidal patients 

(Response 2) As part of the review of 

the public comments received in 

response to the proposed order, FDA 

considered over 400 scientific articles 

cited in comments or attached to 

comments filed in the ECT public 

dockets. Many of the scientific articles 

included information not within the 

scope of this order; however, some of 

the articles included studies that 

investigated the SE of ECT for catatonia, 

mania, schizophrenia, and 

schizoaffective disorder, and use of ECT 

in children, adolescents, and adults, 

which are indications within the scope 

of this final order. Many of these articles 

also provided information on research 

published since 2010, after the literature 

review was conducted for the 2011 

Panel on classification of ECT devices. 

Of the information submitted in 

response to the proposed order, FDA 

reviewed many articles containing valid 

scientific evidence regarding the SE of 

ECT for certain intended uses, which 

are within the scope of this 

reclassification effect, including 

catatonia and severe MDE associated 

with MDD or BDP for the indicated 

populations. In addition, 29 articles 

referenced in the ECT public dockets 

contain valid scientific evidence on the 

SE of ECT in the adolescent 

subpopulation (patients age 13 years to 

less than 18 years). The sections below 

further discuss FDA’s review of this 

evidence and conclusions. 

Based on evaluation of this evidence, 

FDA is including in the final order to 

reclassify ECT the indication of 

catatonia for patients who are treatmentresistant or who require a rapid 

response due to the severity of their 

psychiatric or medical condition in 

addition to treating a severe MDE 

(associated with MDD or BPD). FDA 

believes that the totality of evidence 

supports the determination that the 

special controls identified in this final 

order, along with general controls, are 

sufficient to provide a reasonable 

assurance of SE for these indications. 

For the other indications cited in the 

ECT public dockets that are within the 

scope of this classification effort, FDA 

has concluded that there was 

insufficient scientific evidence to 

support reclassification. 

Several comments posted to the ECT 

public docket in response to the 

proposed order, including comments 

from professional societies and 

organizations, physicians, and other 

ECT practitioners, were supportive of a 

class II recommendation for catatonia or 

a severe MDE associated with MDD or 

BPD in adolescents, and in some cases, 

younger children. While ECT devices 

are historically cleared with no specific 

age indicated, the proposed order for 

ECT recommended that the indications 

for use be limited to use of the device 

in patients 18 and above. Consistent 

with the cleared indications, FDA’s 

Executive Summary for the 2011 Panel 

to discuss reclassification did not 

include a review on the use of ECT in 

different age groups; however, 

substantive comments were provided 

during the open public hearing section 

both for and against the use of ECT in 

children and adolescents (Ref. 4). In 

response to the comments 

recommending expansion of the age 

range of adolescent patients, under 

section 515(i)(2) of the FD&C Act, FDA 

assessed the articles submitted in the 

ECT public dockets (sources of 

information listed in response to 

Comment 1 above) to evaluate the SE 

evidence supporting the use of ECT in 

younger populations (i.e., children and 

adolescents). 

FDA evaluated ECT use in treating a 

number of psychiatric or medical 

conditions (e.g., a severe MDE 

associated with MDD or BPD, catatonia, 

schizophrenia, schizoaffective disorder, 

and mania) in these younger 

populations. Limited experience and 

only a few reports were available for 

patients less than and including 12 

years of age (i.e., children). The majority 

of studies focused on catatonia or a 

severe MDE associated with MDD or 

BPD in patients age 13 years and older. 


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For those studies that did report clinical 

outcomes in adolescent patients, results 

were generally favorable in treating 

catatonia or a severe MDE associated 

with MDD or BPD. Treatment 

approaches (i.e., electrode placement, 

administration, and safeguards) were 

similar between adult and adolescent 

subpopulations. As such, the literature 

provided in the ECT public dockets 

supports a reclassification to class II for 

the use of ECT in treating catatonia or 

a severe MDE associated with MDD or 

BPD, for patients age 13 years and older 

who are treatment-resistant and who 

require a rapid response due to the 

severity of their psychiatric or medical 

condition, with the establishment of 

special controls (discussed in more 

detail below in section III.A.3). FDA’s 

evaluation is based on a reassessment of 

the published literature referenced in 

the Executive Summary to the 2011 

Panel, comments and literature received 

in the ECT public dockets, and review 

of the 2011 Panel meeting transcript. 

Based upon FDA’s review of the 

scientific literature submitted in the 

comments received in the ECT public 

dockets, and an assessment of the 

totality of the evidence, FDA is 

reclassifying ECT devices for a broader 

population than identified in the 

proposed order. The reassessment of 

evidence including scientific articles are 

organized into four subsections 

consisting of: (1) Safety of ECT in 

treating catatonia or a severe MDE 

associated with MDD or BPD; (2) 

effectiveness of ECT for catatonia; (3) 

effectiveness of ECT for patients 13 

years and older; and (4) effectiveness of 

ECT for schizophrenia, schizoaffective 

disorder, and mania. The specific 

indications within the scope of this final 

order include only those for which FDA 

has cleared 510(k) submissions. In this 

summary, we do not include isolated 

case reports. 

1. Safety of ECT in Treating Catatonia or 

a Severe MDE Associated With MDD or 

BPD 

Overall, the published literature 

provided since 2010 in the comments 

received in the ECT public dockets and 

reviewed by FDA provided information 

on over 1,000 patients, and included 

information regarding ECT treatment 

outcomes in adults, adolescents, and 

children. The reviewed published 

literature included prospective and 

retrospective studies, randomized 

patient treatment schedules (e.g., 

number of treatments per week), and 

either administered unilateral or 

bilateral stimulation. The majority of 

studies reported the safe use of ECT 

with minimal and reversible adverse 

events, and in some cases, patient 

memory and mood improved while 

treating catatonia or a severe MDE 

associated with MDD or BPD; positive 

results included outcomes in both 

adults and adolescent subpopulations. 

Six studies (Refs. 5–10) provided 

detailed safety data on patients (N=609) 

for review and further discussion below. 

Fernie et al. (Ref. 5) conducted a 

retrospective study to evaluate the 

persistence of cognitive side effects of 

ECT in a retrospective case study of 126 

patients treated with ECT between June 

2010 and October 2012 at the Royal 

Cornhill Hospital, Aberdeen, Scotland. 

Results from validated longitudinal 

neuropsychological tests (the Cambridge 

Neuropsychological Test Automated 

Battery spatial recognition memory test 

(CANTAB)) and subjective reports of 

memory function showed that while the 

performance was poorer compared with 

baseline for tests administered up to 3 

months following completion of ECT 

therapy, these effects were transient and 

improved at 6 months. In some cases, 

mood and subjective memory scores 

improved following ECT. The Mini 

Mental State Exam (MMSE) 

demonstrated improvement over 

baseline starting from 1 month 

following therapy. Overall, the 

application of ECT had reversible 

cognitive deficiencies compared to preECT treatment scores, a measure of 

safety, and in some assessments 

(CANTAB, subjective reports of memory 

function, and MMSE) showed patient 

improvement. 

Kirov et al. (Ref. 6) conducted a 

retrospective review of 10 years of 

cognitive performance data that 

included 199 patients and 500 

assessments. Cognitive testing consisted 

of a battery of nine tests including 

backward digit span, word, shape, and 

face recognition, verbal fluency, 

complex figure immediate recall, and 

trail making. Not all subjects were 

capable of performing all tests and parts 

of the battery changed over time. Results 

(linear mixed regression analyses) 

demonstrated that age, severity of 

depression at the time of testing, and 

number of days since the last ECT 

session were the major factors affecting 

cognitive performance, but the total 

number of previous ECT sessions did 

not have a measurable impact on 

cognitive performance, which further 

supports the safety of ECT in not 

leading to cumulative cognitive deficits. 

Maric et al. (Ref. 7) prospectively 

studied 30 patients with MDD at 

baseline, shortly after ECT treatment, 

and at 1 month post treatment using the 

learning and visual, spatial, and figural 

memory tests of CANTAB. Severity of 

depressive symptoms as measured by 

healthcare professional-rated and selfrated instruments was significantly 

reduced over time with treatment, as a 

measure of the effectiveness of ECT. At 

the same time, the neuropsychological 

tests did not detect any significant 

memory impairment and showed 

improvement on visual memory and 

learning at 1 month and in the 

immediate post-treatment period, 

indicating no prolonged or significant 

ECT-related memory deficits. These 

improvements correlated with 

improvement in depression while 

serious adverse events were not 

reported. 

Spaans et al. (Ref. 8) compared 

unilateral brief pulse ECT with 

unilateral ultra-brief pulse ECT for the 

treatment of major depression. In this 

double-blind randomized study 

conducted in 3 tertiary psychiatric 

hospitals in the Netherlands, 116 

patients entered the study and of those, 

87 completed the study (until remission 

or 12 treatments). Seventy-six (n=76) 

patients were available with pre- and 

post-ECT assessments. Blinded 

cognitive assessment was done before 

ECT treatment was started and again 

within 2 days to a week after all 

treatments were completed. Patients on 

average received about eight treatments 

(average 7.1 in the brief pulse group vs. 

9.2 in the ultra-brief pulse group). To 

assess cognitive function, several 

neuropsychological tests were 

administered including the 

Autobiographical Memory Interview 

and the Amsterdam Media 

Questionnaire, which is a public event 

questionnaire with questions grouped 

by decade about events from the 

decades of the 1970s through the 2000s. 

Other cognitive domain tests were also 

conducted. No significant difference 

was seen in retrograde amnesia between 

the two treatment groups. Change in 

recall performance and fluency tests 

were also similar between the two 

groups. There was not a significant 

difference in performance in the 

cognitive tests following ECT for any of 

the cognitive tests during the course of 

study. The authors also reported 

mitigating adverse effects on cognition 

by lengthening the time between 

treatments to provide patients with 

more time to recuperate, thereby further 

characterizing how ECT treatment can 

be applied safely. 

Semkovska et al. (Ref. 9) 

prospectively studied 138 patients with 

major depressive episodes who were 

treated in a national ECT study in which 

patients were randomly assigned to 

receive bitemporal (69 patients) or rightside unilateral ECT (69 patients). This 


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study included 3-month and 6-month 

followup assessments. Adverse events 

were similar for the unilateral and 

bitemporal groups. Following treatment, 

headache was the most commonly 

reported adverse physical effect 

(approximately 27 percent of subjects). 

Nausea (approximately 14 percent), and 

muscle pain (approximately 10 percent) 

were also reported. Significant acute 

adverse events associated with 

treatment included six patients (4 

unilateral, 2 bitemporal) who 

experienced ECT related hypertension. 

Also, one patient developed 

laryngospasm with temporary drop in 

oxygen saturation, one patient required 

treatment for sinus tachycardia, one 

patient developed bradyarrhythmia, and 

one patient developed a pulmonary 

embolus after the fifth treatment. No 

adverse events required patients to 

discontinue the study, thereby enabling 

patients to continue treatment. Positive 

responses to the treatments were seen in 

both treatment groups. 

Ghaziuddin et al. (Ref. 10) conducted 

a retrospective study of 16 adolescents 

treated for depression with ECT. 

Cognitive tests before ECT treatment 

were compared to tests administered an 

average of 7 days following completion 

of the ECT treatment (immediate testing) 

and again at an average of 8.5 months 

following completion of ECT treatment. 

The comparison of pre-ECT and the 

immediate post-ECT testing 

demonstrated significant impairments of 

concentration and attention, verbal and 

visual-delayed recall, and verbal 

fluency. A complete recovery of these 

functions was noted in the cognitive 

testing conducted at 8.5 months. There 

was no deficit in the ability to problem 

solve during the initial or the 

subsequent testing. Cognitive 

parameters found to be impaired during 

the first few days of ECT were recovered 

over several months following the 

treatment. Therefore, there was no 

evidence of long-term damage to 

concentration, attention, verbal and 

visual memory, or verbal fluency. There 

were also no impairments of motor 

strength and executive processing, even 

during the early (within 7 to 10 days) 

post-ECT period. 

Considering the studies summarized 

above as well as the additional literature 

referenced in the ECT public dockets 

and the deliberation of the 2011 Panel, 

there is sufficient scientific evidence 

demonstrating, with the establishment 

of special controls in combination with 

general controls, a reasonable assurance 

of the SE for the use of ECT in treating 

a severe MDE associated with MDD or 

BPD and safety for treating catatonia in 

patients who are treatment-resistant or 

who require a rapid response due to the 

severity of their psychiatric or medical 

condition (see effectiveness of ECT for 

catatonia discussion in following 

subsection). ECT in the indicated 

populations provides a treatment option 

for serious diseases where other 

treatments are less or minimally 

effective. Based on the totality of 

available evidence, FDA has determined 

that the designated special controls 

mitigate the risks associated with use of 

ECT in this patient population and 

provide a reasonable assurance of SE. 

2. Effectiveness of ECT for Catatonia 

The 2011 Panel was evenly split 

regarding their recommendation for the 

reclassification of the use of ECT for 

catatonia. Several members of the 2011 

Panel who recommended class II for 

catatonia pointed out that this 

psychiatric disorder is among the most 

severe and potentially life-threatening 

and requires a rapid response. 

In the public comments in response to 

the proposed order, 24 published 

articles were submitted as attachments 

related to the use of ECT for catatonia. 

Of these, 14 were published after FDA’s 

systematic literature review performed 

for the 2011 Panel meeting (Refs. 11– 

25). As was the case at the 2011 Panel, 

there remain no randomized controlled 

trials of ECT in catatonia. The articles 

published after the 2011 Panel are 

primarily case series reports, 

retrospective chart reviews, and 

systematic literature reviews. All the 

studies reported on patient outcomes, 

with the majority of studies reporting 

favorable SE data. 

The systematic review from 2015 by 

Luchini et al. (Ref. 18) identified 8 

retrospective or observational studies 

that included at least 10 or more 

subjects. Collectively, these 8 studies 

represented 346 catatonic patients who 

received ECT. Response rates ranged 

from 80 percent to 100 percent. Rates for 

adverse events were not provided, but 

with regard to safety, the authors cite 

the transient cardiovascular events that 

need to be monitored and managed, 

including parasympathetic mediated 

bradycardia or temporary asystole and 

post-seizure sympathetic stimulation 

that can lead to sinus tachycardia, 

bigeminy or trigeminy, or ventricular 

arrhythmia in as many as 80 percent of 

patients with known cardiovascular 

risk. Other risks are those associated 

with administration of anesthesia in a 

catatonic patient. These side effects are 

generally transient and resolve without 

adverse sequelae. 

A noteworthy series of the case series 

reports (Refs. 19 and 20) all consistently 

found ECT to be very effective for the 

treatment of catatonia with relatively 

few adverse events reported in the 

treated patients. Given the clinical 

presentation of patients with catatonia, 

including the lack of verbal and motor 

response due to the etiology of the 

disease, the positive clinical outcome is 

unlikely to be susceptible to placebo 

effects; therefore, FDA believes the welldocumented case series and open-label 

trials for the use of ECT in catatonia 

support the recommendation to include 

catatonia in class II. 

The valid scientific evidence 

evaluated has enabled FDA to determine 

that ECT for catatonia can be classified 

as class II because general controls, in 

combination with special controls, are 

sufficient to provide a reasonable 

assurance of SE. Based on a review of 

the published literature to date, the 

recommendations from the 2011 Panel 

meeting, and comments received in the 

ECT public dockets, FDA has 

determined that sufficient evidence 

exists to establish special controls and 

support a revision of the proposed 

classification of ECT for the treatment of 

catatonia to class II. ECT for catatonia 

presents the same types of risks to 

health and would be subject to the same 

types of special controls identified for a 

severe MDE associated with MDD or 

BPD in patients who are treatmentresistant or who require a rapid 

response due to the severity of their 

psychiatric or medical condition. 

Further, clinical guidelines for 

schizophrenia published in 2012 from 

the World Federation of Societies of 

Biological Psychiatry (WFSBP) (Ref. 26) 

recommend consideration of ECT for 

catatonia as an alternative when rapid 

resolution is necessary or when an 

initial trial of benzodiazepines has 

failed. Therefore, instead of calling for 

PMAs for ECT devices for the treatment 

of catatonia, FDA has satisfied the 

requirements under section 515(i)(2) of 

the FD&C Act for revising the proposed 

classification from class III to class II 

(special controls) following 

reassessment of the published literature 

referenced in the Executive Summary to 

the 2011 Panel, and comments and 

literature received in the ECT public 

dockets. 

3. Age Limitations on Adolescent 

Subpopulation for Use of ECT 

In the 2015 proposed order, FDA 

proposed that ECT devices should be 

classified as class II (special controls) 

when used for treating adults and 

adolescents 18 years and older with a 

severe MDE associated with MDD or 

BPD, who are treatment-resistant or who 

require a rapid response due to the 

severity of their psychiatric or medical 


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condition. In response to the proposed 

order, public comments included 

submission of 29 articles regarding the 

use of ECT in children and adolescents. 

Some of these comments recommended 

the age for using ECT should be lower 

than 18 years of age. Half of these 

articles (Refs. 13–17, 21, 25 and 27–31) 

were published after the 2011 meeting. 

Articles published after the 2011 Panel 

meeting included children and 

adolescents with a variety of psychiatric 

conditions, including catatonia, a severe 

MDE associated with MDD or BPD and 

childhood schizophrenia. 

Because the current labeling of legally 

marketed ECT devices does not include 

specific age limitations for any 

indication within the scope of this 

classification and FDA received public 

comments advocating expansion to 

include the adolescent age range, FDA 

believed it was important to reassess the 

evidence and conduct a systematic rereview of valid scientific evidence for 

the use of ECT in catatonia or a severe 

MDE associated with MDD or BPD in 

different age groups. Accordingly, 

similar to the treatment of catatonia, 

FDA conducted a reevaluation of the SE 

of ECT for use in the adolescent 

subpopulation by reassessing the 

published literature referenced in the 

Executive Summary to the 2011 Panel, 

and in comments and literature received 

in the ECT public dockets relating to the 

adolescent age range for using ECT 

under section 515(i)(2) of the FD&C Act. 

Unlike the evidence reported for the 

adolescent population, limited 

experience and only a few isolated 

reports were available for patients less 

than or including 12 years of age. 

Therefore, this age range was not reevaluated. 

With regard to safety of ECT in 

treating catatonia or a severe MDE 

associated with MDD or BPD, 

specifically in individuals under the age 

of 18, Jacob et al. (Ref. 17) conducted a 

10-year retrospective chart review of all 

adolescents and children who had 

received at least one session of ECT 

therapy in the Child and Adolescent 

Psychiatry Centre, National Institute of 

Mental Health and Neurosciences. 

Twenty-two patients, most who were 

severely ill, received therapy in the 10- 

year window. In this group, the majority 

of patients had no adverse effects; four 

patients (18.4 percent) experienced 

headache immediately after the ECT 

procedure, and three of eight monitored 

patients had prolonged seizures (greater 

than 2 minutes). At discharge, 

approximately 80 percent were rated as 

‘‘much improved’’ or ‘‘very much 

improved’’ based on the Clinical Global 

Impressions-Improvement (CGI–I) scale. 

Cohen et al. (Ref. 32) investigated 

cognitive impairment at long-term 

followup in adolescents treated with 

ECT for severe mood disorders and 

compared the neuropsychological test 

results of the ECT-treated subjects with 

psychiatric comparison subjects 

matched for sex, age, and diagnosis. 

This study found that cognitive test 

scores of the subjects treated with ECT 

were similar to those subjects who did 

not receive ECT. In the ECT treated 

group 6 of the 10 subjects reported 

having had memory losses immediately 

after ECT treatment and 1 reported longterm subjective memory impairment. In 

the long-term followup study (3.5 years 

average), the cognitive tests of 

anterograde memory in the ECT treated 

group showed no measurable difference 

compared to the matched group. 

A systematic review by Lima et al. 

(Ref. 28) published in 2013 found 212 

published studies on the use of ECT in 

children and adolescents. Of these, 39 

studies met the authors’ criteria for 

inclusion in their systematic review. 

The reviewed studies specified 

indications of ECT use in adolescents, 

evaluated the effectiveness of this 

therapy in producing remission, and 

explored the potential risks and 

complications of the procedure. Overall, 

the results of this systematic review 

found that the use of ECT in adolescents 

is considered a highly effective option 

for treating several psychiatric disorders 

including MDE and catatonia, achieving 

high remission rates, and presenting few 

and relatively benign adverse effects. 

These authors conclude that the risks to 

adolescents can be mitigated by the 

correct use of the technique and are 

considered minimal when compared to 

the treatment benefit. 

Consoli et al. (Ref. 33) investigated the 

use of ECT in adolescents with a 

primary diagnosis of catatonia. These 

authors reviewed the published 

literature (1985–2009) on the use of ECT 

in child and adolescent patients with 

catatonia. In their meta-analysis of 

studies that included 10 patients or 

more, only 1 study of 12 patients 

included subjects below the age of 13 (it 

included patients in the age range of 12 

to 18). This review found that ECT is 

used as a second-line management after 

high-dose benzodiazepine trials and that 

ECT is an effective, safe, and useful 

procedure in the treatment of catatonic 

adolescents (n=59). 

The largest systematic review of the 

use of ECT in young people was 

reported by Rey and Walter (Ref. 34). 

This 1997 review assessed 60 studies 

comprising nearly 400 patients, with the 

majority of patients between the ages of 

13 and 18 years and found rates of 

improvement across studies, including 

63 percent for depression and 80 

percent for catatonia. Serious 

complications were very rare, whereas 

minor, transient side effects appeared 

common. These authors concluded that 

ECT in young people appears to be 

similar in SE to that found in adults, but 

note that these results are limited by the 

lack of controlled clinical trials. 

FDA’s review of other retrospective 

studies submitted as comments to the 

proposed order have found similar 

results. Walter and Rey (Ref. 35) studied 

42 patients aged 14 to 18 with a variety 

of psychiatric diagnoses who received 

ECT therapy and observed marked 

improvement or resolution of symptoms 

in about half of the patients who 

completed the therapy. Ghaziuddin et 

al. (Ref. 36) observed clinically 

significant improvement in 11 of 11 

adolescent patients in the 13- to 18-year 

range with major depressive episode. Of 

these 11 adolescents 7 achieved 

euthymia, which is defined as a 

Children Depression Rating ScaleRevised (CDRS–R) of 40 or less. Strober 

et al. (Ref. 37) reviewed the treatment of 

10 adolescents (13–17 years) with major 

depression or BPDs and observed 

complete remission in 6 patients and 

partial remission in the other 4. Cohen 

et al. (Ref. 38) studied 21 adolescents 

(age 14–19) and observed 100 percent 

response in major depression and 75 

percent response in bipolar-mania. In 

one of a few studies with a control arm, 

Kutcher and Robertson (Ref. 39) studied 

32 bipolar patients and compared 16 

subjects who received ECT to 16 

(serving as controls) who were offered 

ECT but refused it. The ECT group 

improved significantly more than the 

group who did not receive ECT and the 

duration of their hospitalization was cut 

in half (74 vs. 176 days on average). 

Taken as a whole, these reports are 

consistent in reporting effectiveness of 

ECT in treating depressive episodes and 

catatonia in young adolescents. 

In addition, the American Academy of 

Child and Adolescent Psychiatry 

(AACAP) has published guidelines for 

the use of ECT in adolescents and 

children. In the AACAP publication on 

practice parameters (Ref. 40), they 

reviewed selected publications since 

1990. While the use of ECT in 

adolescents is uncommon within the 

age of 13 to 17 (representing about 1.5 

percent (Ref. 40) of the total population 

of individuals who receive ECT), the 

benefits of therapy are acknowledged. 

This publication also indicates that 

while the use of ECT in patients 12 

years of age or younger is rare and 

necessitates further study, the 

guidelines identify risk mitigations of 


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the technique. Overall the AACAP 

recommends that patients 13 years of 

age and older are appropriate for 

considering use of ECT in treating 

catatonia or a severe MDE associated 

with MDD or BPD. 

While the discussion at the 2011 

Panel meeting of ECT use in treating 

adolescents with catatonia or a severe 

MDE associated with MDD or BPD was 

limited, the 2011Panel did hear and 

discuss comments during the open 

public hearing both on adolescent age 

groups as well as considerations as it 

relates to ECT (Ref. 41). Although a 

primary emphasis was upon adult 

populations towards the conclusion of 

the 2011 Panel proceedings, sufficient 

and compelling discussion was heard 

regarding adolescent response to ECT, 

especially during the opening public 

hearing comments. In summary, there 

was the 2011 Panel discussion focused 

on adolescent patient use of ECT, as 

well as many comments including 

literature references addressing 

inclusion and exclusion on the basis of 

age for specific indications for use of 

ECT (e.g. schizophrenia, bipolar manic 

states, schizoaffective disorder, and 

schizophreniform disorder). 

Additionally, FDA conducted a 

review of the MAUDE database from 

August 2016 to December 2017. The 

additional MDRs from the MAUDE 

database do not appear to be 

significantly different from those 

compiled for the 2011 Panel meeting 

and the small number of MDRs is 

consistent with the safety record 

reported in the literature for ECT. 

As stated previously, FDA has 

reevaluated the valid scientific evidence 

for use of ECT in treating adolescents 

and, in the case of catatonia or a severe 

MDE associated with MDD or BPD, we 

believe the requirements under section 

515(i)(2) of the FD&C Act for revising 

the classification of the age limitation 

for the adolescent subpopulation are 

satisfied. Based upon the assessment of 

the totality of evidence, FDA believes 

that special controls, along with general 

controls, can provide a reasonable 

assurance of SE of the use of ECT for all 

adolescent age groups (13–21 years) 

and, therefore, is modifying the 

designation for class II for the 

indications of catatonia or a severe MDE 

associated with MDD or BPD in the 

adolescent subpopulation to include 

individuals 13 years and older who are 

treatment resistant or require a rapid 

response. 

4. Effectiveness of ECT for 

Schizophrenia, Schizoaffective 

Disorder, and Mania 

During the 2011 Panel meeting, 

members expressed diverse opinions on 

the effectiveness of ECT for treatment of 

schizophrenia, schizoaffective 

disorders, and mania, but the majority 

of the 2011 Panel members supported 

class III designation for these 

indications. A number of published 

articles on the use of ECT to treat 

schizophrenia and schizoaffective 

disorder were submitted and reviewed 

as attachments to the ECT public 

dockets. Of these, approximately 15 

were published after the 2011 Panel 

meeting. The majority of these articles 

published after the 2011 Panel meeting 

review were either isolated case reports 

or retrospective chart reviews. SE data, 

including clinical outcomes, for both 

adults and adolescents with a primary 

diagnosis of schizophrenia or 

schizoaffective disorder (Refs. 14, 23, 

30, 42, and 43–47) resulted in variable 

patient outcomes, while mania had 

more positive outcomes. However, the 

available evidence across patients for 

these conditions was limited when 

compared to the available evidence for 

other conditions presented in this final 

order for which class II is designated. 

There was one published practice 

guideline (Ref. 48) that provided 

updated treatment recommendations for 

the acute treatment of schizophrenia 

and the management of treatment 

resistance. This guideline concludes 

that there is limited evidence for general 

efficacy of ECT in treatment-resistant 

schizophrenia, but that in certain cases 

ECT as an adjunct to antipsychotic 

therapy may be appropriate. This is in 

contrast to the guideline 

recommendation for catatonia where 

ECT is considered an important 

therapeutic alternative (see above 

discussion in section III.A.2, 

Effectiveness of ECT for Catatonia). 

Iancu et al. (Ref. 44) conducted a 

retrospective chart review of 20 

consecutive patients with schizophrenia 

or schizoaffective disorder who were 

individually treated with at least 30 ECT 

sessions at the Tel Aviv University. All 

of these patients had been hospitalized 

for most or all of the previous 3 years. 

In this group of chronically hospitalized 

patients, the authors conclude that ECT 

treatment improves general function 

and reduces verbal aggression and selfharm. This patient group had a mean 

age of 65 and the average age at disease 

onset was 22 years. Patients were 

selected for treatment based on 

inadequate response to medications, 

history of a good response to ECT in the 

past, aggression, self-injury, and refusal 

to eat or drink. Improvement was seen 

on all assessed scales including the 

Global Assessment of Functioning, 

Clinical Global Impression-Severity and 

Overt Aggression Scale but most 

changes before and after ECT were not 

clinically meaningful or statistically 

significant. 

Kristensen et al. (Ref. 45) reviewed 

the treatment of 72 consecutive 

hospitalized patients between 2003 and 

2008 from two hospitals in the 

Copenhagen area. Fifty-five had a 

diagnosis of schizophrenia and 17 a 

diagnosis of schizoaffective disorder. 

All patients had been hospitalized for at 

least a week and the indication for ECT 

was an increase in acute episodes or 

symptom severity leading to 

hospitalization. The patient ages ranged 

from 18 to 79 and the disease duration 

ranged from 1 to 40 years. The duration 

of the patients’ psychotic behavior 

ranged from a few weeks to over 5 years. 

ECT was effective in this severely ill 

population as reflected by a measure of 

relief from psychosis and disruptive 

behavior as described in the patient 

charts. Using information about the size 

of the catchment area for the involved 

hospitals, the authors were able to 

estimate that only about 1.5 percent of 

patients with schizophrenia received 

ECT over the 6-year study period in this 

area of Copenhagen. Because this 

represents a select and small fraction of 

the population with schizophrenia, it is 

not possible to generalize these results 

to the general population of 

schizophrenic individuals. 

Petrides et al. (Ref. 47) studied 

patients with clozapine-resistant 

schizophrenia in a single-blind study 

where 20 clozapine-resistant patients 

received ECT as an adjunct to the 

clozapine treatment and 19 received 

usual (clozapine) care. Response was 

defined as a 40 percent or greater 

reduction in symptoms based on the 

psychotic symptom subscale of the Brief 

Psychotic Rating Scale, a Clinical Global 

Ratings-Severity (CGI–S) rating of less 

than 3, and a CGI improvement rating 

less than or equal to 2 following an 8- 

week course of treatment. Fifty percent 

of patients in the treatment group that 

received the ECT met the response 

criteria compared to none of the patients 

in the control group. FDA believes that 

these results, while promising, have 

significant limitations. The Denmark 

Study represents a population of 

hospitalized patients who may not be 

representative of the general population 

of schizophrenic individuals. The 

Petrides study was small and focused on 

the subpopulation of clozapine resistant 

patients and again cannot be 


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extrapolated to the general 

schizophrenic patient population. The 

available valid scientific data on the 

schizophrenic patient population are 

limited and insufficient to demonstrate 

that the use of ECT in schizophrenia 

patients can be safe and effective with 

the use of special controls. 

Other studies have focused on the use 

of maintenance ECT in the treatment of 

patients with schizophrenia and 

schizoaffective disorders (Refs. 23, 27, 

and 46). In each of these studies, the 

patient populations are highly selected 

and represent a small minority of the 

schizophrenic or schizoaffective 

populations. Also, a number of 

additional therapies were given to 

patients, with limited use of ECT in 

some cases. While the results are 

promising in these selected patient 

populations, the evidence available is 

limited. Moreover, practice guidelines 

have not called out schizophrenia and 

schizoaffective disorders for treatment 

with ECT. With limited data on different 

select subpopulations, FDA believes 

that there is insufficient evidence, at 

this time, to establish special controls 

for the subpopulations that might 

benefit from the treatment. Therefore, 

FDA believes that the use of ECT to treat 

schizophrenia or schizoaffective 

disorder is appropriately currently 

regulated in class III. 

Ten published articles were submitted 

to the ECT public dockets regarding the 

SE of ECT for mania. All the articles 

were published prior to the 2011 Panel 

meeting and no ‘‘new information’’ on 

the SE of mania was submitted to the 

ECT public dockets that were not 

available to the 2011 Panel. In reviewing 

the ECT public dockets, FDA did not 

identify additional scientific 

information since the 2011 Panel 

meeting supportive of reclassifying 

mania to class II. The published reports 

on using ECT for the treatment of mania 

are relatively few, have small numbers 

of patients, and acknowledge that there 

are viable alternative treatments in this 

population. 

In one study, Black et al. (Ref. 49) 

systematically reviewed records of 

patients treated with ECT for mania or 

depression over a 12-year period at the 

University of Iowa Hospital Center. 

Patient outcome was divided into five 

categories based on patient discharge 

notes with the category ‘‘marked 

improvement’’ applied to patients 

where the discharge notes suggested 

there was complete resolution of 

depressive or manic symptoms. In this 

review, there was marked improvement 

in a substantial majority of the patients 

with depression and with mania. 

However, the total numbers of patients 

treated included 422 patients treated for 

depression but only 37 patients treated 

for mania. As a result of the differences 

in numbers of patients treated, there is 

greater uncertainty in the significance of 

this retrospective study in mania 

compared with depression. 

Mukherjee et al. (Ref. 50) reviewed 

the treatment of 30 manic patients at a 

psychiatric institute in India treated for 

mania with ECT. They observed 

remission of mania in 26 of 30 patients. 

Results are confounded though by the 

concurrent prescription of neuroleptics 

at the time of admission for treatment. 

Small et al. (Ref. 51) compared ECT 

with lithium maintenance therapy to 

lithium treatment in 34 patients 

hospitalized for mania. Although the 

patients who underwent ECT improved 

more than the lithium treatment 

patients during the first 8 weeks, the 

study found no differences in clinical 

ratings after 8 weeks and no differences 

in rates of relapse, recurrence, or rehospitalization in the followup period, 

when compared to pharmacotherapy. 

FDA concluded that based on the 

published literature referenced in the 

Executive Summary to the 2011 Panel, 

comments and literature received in the 

ECT public dockets, the small number 

of patients treated and limited outcomes 

reported, the existence of confounding 

factors in studies, and the availability of 

alternative therapies with similar 

reported effectiveness, that special 

controls cannot be established to 

provide a reasonable assurance of SE, 

and, therefore, it is appropriate to 

maintain ECT to treat mania in class III. 

B. Comments on Reclassifying ECT 

Based on Safety and Effectiveness 

In this section, comments regarding 

the SE of ECT are categorically grouped 

together so that FDA’s responses could 

be addressed by topic instead of each 

comment considered independently. 

(Comment 3) Several comments 

indicated that ECT was not safe and/or 

not effective, particularly in the long 

term. Several comments noted that ECT 

had not been used safely and/or 

effectively in their practice, or on 

themselves as a patient, or on a family 

member or a friend. Several comments 

stated ECT injures patients and is not 

therapy. Several comments also noted 

long-term memory, cognitive, or 

functional impairment following ECT 

administration. Instead of using ECT, 

several comments recommended 

alternative treatments, including 

acupuncture, transcranial magnetic 

stimulation, or nutritional or solar 

therapy. 

(Response 3) Comment 3 reflects 

significant concern on the part of some 

patients and caregivers about the risks 

of ECT. Table 1 shows how FDA 

believes that the risks to health 

associated with ECT for treatment of 

catatonia or a severe MDE associated 

with MDD or BPD can be mitigated by 

the designated special controls. 

TABLE 1—IDENTIFIED RISKS TO HEALTH AND MITIGATION MEASURES FOR ECT 

Identified risks to health Mitigation measure(s) 

Adverse reaction to anesthetic agents/neuromuscular blocking agents .. Labeling 

Adverse skin reactions ............................................................................. Biocompatibility Labeling 

Cardiovascular complications ................................................................... Labeling 

Cognitive and memory impairment .......................................................... Technical parameters, Non-clinical test data, Labeling 

Death ........................................................................................................ Labeling 

Dental/oral trauma .................................................................................... Labeling 

Device malfunction ................................................................................... Performance data, Electromagnetic compatibility, Software verification, 

validation, and hazard analysis 

Manic symptoms ....................................................................................... Labeling 

Pain/discomfort ......................................................................................... Labeling 

Physical trauma ........................................................................................ Labeling 

Prolonged or tardive seizures .................................................................. Labeling 

Pulmonary complications .......................................................................... Labeling 

Skin burns ................................................................................................. Performance data, Labeling 

Worsening of psychiatric symptoms ......................................................... Labeling 


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2FDA supports the principles of the ‘‘3Rs,’’ to 

reduce, refine, and replace animal use in testing 

when feasible. We encourage sponsors to consult 

with us if it they wish to use a non-animal testing 

method they believe is suitable, adequate, 

validated, and feasible. We will consider if such an 

alternative method could be assessed for 

equivalency to an animal test method. 

FDA acknowledges that the 

individuals for whom ECT therapy may 

be prescribed are at significant risk for 

complications including death from 

their underlying conditions. Milstein et 

al. (Ref. 52) completed a retrospective 

study of 1,494 psychiatric subjects 

followed for 5 to 7 years following 

hospitalization for a psychiatric 

condition. They found 76 deaths in this 

group of patients with 16 of the deaths 

being by suicide. In this group, ECT was 

not protective but also did not increase 

the risk for death. Labeling will be 

required to explain the potential risks 

and benefits to ensure that patients, 

caregivers, and family members 

understand the magnitudes of the risks 

and the benefits of ECT. FDA 

acknowledges the important role of 

patient preference and patient choice in 

selecting treatments. Patient preference 

is important in balancing the 

individuals’ assessment of risk and 

benefit, especially in the presence of 

serious and potentially life-threatening 

disorders. This classification is 

concerned with the use of ECT for 

certain specified uses and does not 

address the potential use of other 

treatments that patients may consider. 

FDA believes that for certain 

indications, special controls as 

established in this final order, along 

with general controls, provide a 

reasonable assurance of SE of ECT by 

mitigating the identified risks to health. 

As such, FDA disagrees with the 

comments that ECT should not be 

reclassified for any indications to class 

II. 

FDA reclassifies devices under 

section 515(i)(2) of the FD&C Act in 

accordance with the criteria in section 

513(a) of the FD&C Act. The primary 

purpose of reclassification is to apply 

the appropriate level of regulatory 

controls for a device based on the most 

current information regarding its SE. 

FDA notes that reclassification does not 

imply that ECT is a preferred form of 

treatment. FDA recommends that 

patients consult with their healthcare 

providers to determine if ECT is the best 

treatment option for them or if there are 

suitable alternative treatments. FDA 

notes that the patient labeling is 

required to list alternative treatments 

(see § 882.5940(b)(1)(ix)(E) (21 CFR 

882.5940(b)(1)(ix)(E))). 

(Comment 4) Some comments stated 

that FDA did not consider animal 

studies and death data in proposing to 

reclassify these devices. 

(Response 4) FDA does not agree with 

these comments. Information about 

adverse events, including death, was 

carefully considered regarding the 

reclassification action. Section 4.8 of the 

safety review in the FDA Executive 

Summary prepared for the 2011 Panel 

meeting specifically addresses the risk 

of death. Data for deaths from MDR 

analyses was also considered and made 

part of the risks identified in the 

proposed order. FDA acknowledges that 

there is uncertainty in the estimate of 

risk of death from these sources of 

information and that the risks are likely 

changing as a result of evolution in the 

practice of medicine. In light of this 

risk, the labeling is required to include 

death (§ 882.5940(b)(1)(ix)(H)(3)(viii)) as 

a risk of the use of ECT. In some cases 

where human experience is limited, 

animal studies can be of significant 

value in predicting outcomes in 

humans.2 However, in this case where 

there is a significant and substantive 

experience with the use of these devices 

to treat humans, FDA believes that the 

human study data are the primary 

sources for review and consideration. 

(Comment 5) Several comments 

opposed the reclassification saying that 

ECT should remain in class III for all 

indications. Several comments 

indicated that current safety or 

effectiveness information was 

insufficient to ensure patient protection. 

Several comments indicated that proof 

of SE should be required before the 

device enters the market. Several 

comments indicated that the 510(k) 

clearance pathway was not sufficient for 

ECT devices. 

(Response 5) FDA disagrees with 

these comments that ECT should not be 

reclassified to class II as specified in 

this final order for certain indications. 

As established in section 513(a)(1)(C) of 

the FD&C Act and 21 CFR 860.3(c)(3), a 

device is in class III if insufficient 

information exists to determine that 

general controls and/or special controls 

are sufficient to provide reasonable 

assurance of its SE. Based on FDA’s 

independent review of the scientific 

evidence, FDA has determined that the 

special controls established in this final 

order, including performance data, 

technical parameters of the device, and 

extensive labeling requirements, along 

with general controls, can provide 

reasonable assurance of SE of ECT for 

the specified class II indications. ECT 

devices for indications in class II will 

require a 510(k) (or an amendment to a 

previously cleared 510(k) if already 

legally marketed) that demonstrates 

compliance with these special controls. 

ECT devices for indications other than 

those being classified into class II will 

require premarket approval as 

insufficient evidence currently exists to 

establish adequate special controls for 

these uses. 

(Comment 6) Several comments 

indicated that ECT did not treat the 

biological basis of depression or other 

mental disorders. Several comments 

indicated that electricity did not treat 

the underlying cause(s) and could 

exacerbate mental disorders. Several 

comments indicated that there is no 

evidence that mental disorders are 

neurobiological. Several comments 

indicated that ECT may be used in 

patients who are misdiagnosed. 

(Response 6) For a device to be 

determined to have a reasonable 

assurance of SE, FDA evaluates the 

device’s performance outcomes relative 

to the indications for use and not 

necessarily the mechanism(s) of action 

of the device, which may not be well 

understood in some cases. For ECT, the 

clinical data reflecting the device’s 

performance in relation to the 

indications for use have been discussed 

above in response to Comment 2. 

Additionally, knowledge of the 

underlying causes of mental disorders is 

not required to evaluate a reasonable 

assurance of the SE of a device type for 

a specified intended use. Therefore, the 

biological basis or cause of the 

underlying mental disorder is outside of 

the scope of this reclassification. 

(Comment 7) Several comments 

suggested that reclassification would 

increase acceptance of ECT. Several 

comments indicated that ECT is not as 

safe or effective when compared to other 

available treatments. Several comments 

opposed the reclassification saying that 

reclassification indicated that ECT is a 

preferred method of treatment. 

(Response 7) The primary purpose of 

reclassification is to apply the 

appropriate level of regulatory controls 

for a device type based on the ability to 

reasonably assure SE. FDA notes that 

reclassification does not imply that ECT 

is a preferred form of treatment. This 

order is neither a recommendation of 

ECT treatment nor a determinant of 

whether ECT is safer or more effective 

than alternative treatments. The purpose 

of the proposed and final order process 

is to identify the regulatory controls 

necessary to reasonably assure SE for 

ECT and to provide the evidence 

supporting this determination. Based 

upon FDA’s assessment, special 

controls, in combination with general 

controls, are necessary and sufficient to 

provide a reasonable assurance of SE for 

the use of ECT in treating catatonia or 


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a severe MDE associated with MDD or 

BPD in patients age 13 years and older 

who are treatment-resistant or who 

require a rapid response due to the 

severity of their psychiatric or medical 

condition. ECT devices for indications 

other than those identified in the 

previous sentence, including 

schizophrenia, schizoaffective 

disorders, schizophreniform disorder, 

bipolar manic states, and catatonia or a 

severe MDE associated with MDD or 

BPD in patients under 13 years or 

patients 13 years or older who are not 

treatment-resistant or who do not 

require a rapid response due to the 

severity of their psychiatric or medical 

condition, will require premarket 

approval. FDA believes that insufficient 

evidence currently exists to establish 

special controls to mitigate the risks to 

health and provide a reasonable 

assurance of SE for those uses. 

(Comment 8) Several comments 

indicated that ECT should be banned. 

Several comments characterized ECT as 

inhumane. Commenters indicated that 

the United Nations Special Rapporteur 

on Torture and Other Cruel Inhuman or 

Degrading Treatment or Punishment 

February 16, 2013, defined ECT without 

consent as torture. 

(Response 8) FDA disagrees that ECT 

should be banned. Section 516 of the 

FD&C Act (21 U.S.C. 360f) authorizes 

FDA to ban a device when, based on all 

available data and information, FDA 

finds that the device ‘‘presents 

substantial deception or an 

unreasonable and substantial risk of 

illness or injury.’’ During review of the 

scientific evidence, FDA did not 

identify sufficient evidence to ban ECT. 

FDA determined that special controls, 

in combination with general controls, 

can mitigate the identified risks of ECT 

for certain intended uses and mitigate 

risks associated with ECT use. FDA 

determined that there is a reasonable 

assurance of SE for ECT treatment for 

the identified indications for use and 

patient populations. Therefore, FDA has 

determined that ECT does not present 

substantial deception or an 

unreasonable and substantial risk of 

illness or injury. 

As noted, we acknowledge the 

February 1, 2013, United Nations Report 

of the Special Rapporteur on torture and 

other cruel, inhuman or degrading 

treatment or punishment by Juan E. 

Me ́ndez does recommend banning the 

administration of non-consensual 

electrical stimulation against persons 

with disabilities (Ref. 53). Persons with 

disabilities include persons with longterm intellectual or sensory 

impairments. The report does not 

address the use of electrical stimulation 

to treat conditions such as a severe MDE 

associated with MDD or BPD, 

schizophrenia, bipolar manic states, 

schizoaffective disorder, 

schizophreniform disorder, or catatonia. 

As noted in the proposed order and 

adopted in this final order, appropriate 

directions for use and specific labeling 

special controls (§ 882.5940(b)(1)(viii) 

and (ix)) are required for the safe use of 

ECT. 

(Comment 9) Several comments were 

concerned that reclassification would 

make it easier for either healthcare 

professionals or non-healthcare 

professionals to overly or 

inappropriately use ECT. Comments 

indicated that ECT may be used to 

shorten hospital stays without regard for 

patient outcomes. Comments indicated 

that ECT may be used to control patients 

or reduce unwanted behavior such as 

screaming rather than as treatment for a 

medical condition. Several comments 

questioned the regulation of ECT use in 

other indications not included in class 

II in the split classification. 

(Response 9) FDA does not regulate 

the practice of medicine (see section 

1006 of the FD&C Act (21 U.S.C. 396)). 

Diagnosis and treatment of patients are 

clinical decisions that fall within the 

practice of medicine. Rather, FDA 

regulates the use of a device as 

indicated by the person or entity 

offering the device for interstate 

commerce. The classification of 

indications for use for ECT devices are 

specified in the identification language 

in the codified classification regulation 

(see § 882.5940). Through the 

classification process, FDA has 

determined the level of regulatory 

control necessary to provide a 

reasonable assurance of SE of ECT 

devices for these indications. ECT is a 

prescription only device that is not safe 

for use except under the supervision of 

a practitioner licensed by law to direct 

the use of the device and for which 

prescription labeling requirements must 

be met (see 21 CFR 801.109). The 

labeled uses of the device must conform 

to the indications that have been cleared 

or approved by FDA through the 

premarket review process. FDA does not 

regulate off-label use of ECT by 

physicians. 

C. Comments on Patient Concerns 

In this subsection, comments on 

patient concerns with using ECT are 

categorically grouped together so that 

FDA’s responses could be addressed by 

topic instead of each comment 

considered independently. 

(Comment 10) Several comments state 

that FDA’s call for PMA applications is 

disingenuous because PMA applications 

have not been required for ECT devices 

since they were originally classified. 

Comments indicate that because the 

proposed order states ECT devices for 

some indications will be in class II, 

device manufacturers will not have an 

incentive to apply for additional 

indications through the PMA process, 

because, under the practice of medicine, 

healthcare professionals can use class II 

ECT devices for indications beyond 

those cleared via 510(k) for indications 

that are in class III. 

(Response 10) FDA disagrees with 

these comments. Finalizing the 

classification of ECT includes a 

requirement that PMA applications be 

submitted prior to marketing of ECT 

devices for indications other than those 

identified as class II within this final 

order, and it is the responsibility of the 

manufacturer to ensure that a PMA 

application is submitted in such 

circumstances. However, FDA is not 

permitted to limit or interfere with the 

authority of a healthcare professional to 

administer any legally marketed device 

to a patient for any condition or disease 

within a legitimate clinician-patient 

relationship. 

(Comment 11) Several comments 

raised concerns about a split 

classification and the conditions under 

which devices could be used under 

either classification. Several comments 

indicated that a split classification 

could restrict the use of ECT for 

indications not included in class II and 

thereby limit treatment options for 

patients. Comments asked if there is 

evidence of patients not receiving 

treatment when ECT devices are in class 

III. Comments asked for guidance on 

whether class II ECT devices can be 

used on patients with a severe MDE 

associated with MDD accompanied by 

another condition. Comments also 

stated concern that class II ECT devices 

will be used as predicate devices for 

other devices with different current or 

voltage strength, or different pulse 

length, pattern or waveform, saying 

such differences could impact safety 

including cognitive side effects and/or 

effectiveness of ECT treatment. 

(Response 11) FDA’s reclassification 

of ECT to class II for the indications 

specified in the final order is an effort 

to make ECT available for the benefit of 

patients with conditions for which 

general and special controls can provide 

a reasonable assurance of SE. For these 

indications, sufficient scientific 

evidence exists for FDA to establish 

special controls that, in combination 

with general controls, provide 

reasonable assurance of SE of ECT. For 

other indications, sufficient scientific 

evidence does not currently exist to be 


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able to establish special controls to 

mitigate the risks to health at this time. 

The indications for which there is 

currently insufficient evidence to 

develop special controls will remain 

class III and require a PMA pursuant to 

section 513(a)(1)(C) of the FD&C Act. 

Because of the differing levels of 

scientific evidence currently available to 

establish special controls for the various 

uses of ECT, a split classification was 

warranted in this case. If warranted by 

new scientific evidence, FDA could 

reclassify ECT for other indications to 

class II in the future. 

Under section 1006 of the FD&C Act, 

FDA is prohibited from interfering with 

the authority of a healthcare 

professional to prescribe or administer 

any legally marketed device to a patient 

within a legitimate clinician-patient 

relationship. As such, FDA does not 

regulate the practice of medicine. 

Rather, FDA regulates the use of a 

device as indicated by the person or 

entity offering the device for interstate 

commerce. The indications for which 

FDA has determined ECT devices have 

a reasonable assurance of SE based on 

the general controls and the identified 

special controls are in the codified 

classification regulation (see 

§ 882.5940). Once a product is approved 

or cleared, a healthcare professional is 

able to prescribe the device based on a 

patient’s condition. ECT is a 

prescription device and FDA relies on 

licensed practitioners to direct its use. 

Treatment of patients remains under the 

clinical discretion of their healthcare 

practitioner. While treatment of patients 

falls under the practice of medicine, 

healthcare professionals should 

carefully consider all ECT device 

labeling, including potential adverse 

events, warnings, and medical 

conditions that can increase patient risk 

when deciding if ECT is appropriate for 

their patients, including those with 

comorbid conditions. The healthcare 

professional is responsible for providing 

appropriate ongoing medical 

management to mitigate any patient 

specific risks associated with comorbid 

conditions. 

If ECT devices are used as predicate 

devices for subsequent ECT devices, any 

differences in the technical parameters 

(e.g., waveform, output mode, pulse 

duration, maximum charge, and energy 

as identified in § 882.5940(b)(1)(i)) 

between the predicate device and the 

new device must be characterized and 

will be considered as part of FDA’s 

substantial equivalence determination 

to ensure that such differences do not 

raise different questions of SE. 

(Comment 12) Several comments were 

concerned that adequate, well-informed 

consent may not take place prior to ECT 

treatment. Several comments indicated 

concern over the use of ECT without 

consent or without full disclosure of 

risks. Several comments were concerned 

with involuntary treatment and its 

outcomes. Comments indicated that 

conversations about potential benefits, 

potential risks, alternative treatments, 

and the typical experience and course of 

ECT treatment should occur over several 

sessions prior to ECT treatment. 

Comments asked that FDA provide 

additional guidance and 

recommendations to healthcare 

professionals on the procedures for 

informing patients and on obtaining 

written informed consent from patients 

or their legally authorized 

representatives prior to ECT treatment. 

Comments indicated that family 

members or other caregivers should be 

included in the informed consent 

process and should provide input on 

how the patient is responding to ECT 

treatment including any adverse events. 

Several comments indicated that ECT 

should only be used in settings of 

formal informed consent, such as with 

a documented checklist or when it is 

specified in a psychiatric advance 

directive. A comment suggests that FDA 

develop a patient decision aid related to 

ECT that considers key clinical variables 

and alternative therapeutic options as 

well as incorporating patient values, 

concerns, and preferences. Several 

comments indicated that the order 

should specify that consent is an 

ongoing process, that information 

should be provided throughout 

treatment, and that at any time during 

the course of ECT treatment, patients 

can request that treatment be stopped 

and can withdraw consent for further 

treatment. Several comments indicated 

that some patients may not be able to 

give consent due to their medical 

condition. 

(Response 12) These comments are 

focused on how patients are informed 

about the risks, benefits, and 

alternatives to ECT. FDA agrees that 

ECT informational material, including 

information about benefits and risks, 

should be discussed with the patient 

and, if applicable, with a designated 

family member or other individual. In 

§ 882.5940(b)(1)(ix), FDA requires that 

certain information be provided in the 

patient labeling for a class II ECT 

device. The appropriate treatments for a 

patient with catatonia or a severe MDE 

associated with MDD or BPD is a 

complex matter that requires the 

supervision of a practitioner licensed by 

law to direct the use of the device. In 

selecting the appropriate treatment, the 

practitioner should consider many 

factors, such as the patient’s medical 

history and the severity of their 

psychiatric or medical condition. FDA 

believes that the device labeling 

required per the special controls will 

provide patients and healthcare 

professionals with information that will 

improve their understanding of the ECT 

device and assist in selecting the 

appropriate treatment for patients. ECT 

is a prescription device, and FDA and 

licensed practitioners are relied upon to 

direct its use. 

Informed consent procedures may 

differ across each State agency, 

institution, hospital, clinic, and 

practice. For ECT treatment, FDA 

expects review boards and State 

agencies to have the appropriate 

requirements for medical professionals 

to provide the appropriate informed 

consent to patients and family members, 

and to take action when necessary. The 

patient labeling is required to include 

information on ECT use, potential 

benefits, warnings regarding risks of 

ECT, and alternative treatments. The 

information required in the patient 

labeling will help patients make an 

informed decision about ECT treatment. 

Patients may also discuss ECT and other 

treatment options with their healthcare 

professionals, family members, or other 

individuals. Patients, or their legally 

authorized representative, may 

withdraw consent and request that ECT 

treatment be stopped at any time. 

According to the Surgeon General, 

involuntary ECT treatment is 

uncommon in the United States. In 

every State in the United States, the 

administration of ECT on an involuntary 

basis requires a judicial proceeding (Ref. 

54). At this time, FDA declines to 

recommend the development of patient 

decision aids related to ECT that 

considers key clinical variables and 

alternative therapeutic options as well 

as incorporating patient values, 

concerns, and preferences. FDA is 

concerned that including such 

information may be more confusing 

than helpful given the complexity of 

treating a number of different 

psychiatric disorders. FDA also requires 

patients consult a practitioner licensed 

by law to administer or use the ECT 

device. 

(Comment 13) Several comments 

indicated training or education should 

be required for healthcare professionals 

to be eligible to administer ECT. Several 

comments indicated that the order 

should specify what type of healthcare 

professional should be able to 

administer ECT. Several comments 

indicated that healthcare professionals 


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other than physicians should be able to 

administer ECT. 

(Response 13) FDA is in agreement 

that there is a need for ongoing training 

for healthcare professionals who 

administer ECT. ECT is a complex 

procedure that requires specialty 

training for reasonably safe and effective 

administration. As stated in the 

proposed order and adopted in this final 

order, FDA is requiring device labeling 

to specify the clinical training that is 

needed by those using the ECT device 

to ensure appropriate use and 

appropriate ongoing medical 

management of the patient. 

(Comment 14) Several comments 

indicated that those who administer 

and/or study ECT have conflicts of 

interest. Several commenters noted that 

the doctors recommending ECT 

treatment profit financially from 

administering ECT. Commenters asked 

if FDA considers possible conflict of 

interests for researchers when assessing 

the validity of ECT research used to 

support the reclassification. 

(Response 14) The potential for 

conflict of interest of healthcare 

professionals administering ECT is 

outside the scope of this final order and 

does not bear upon FDA’s careful 

evaluation of the valid scientific 

evidence on the SE of ECT. FDA’s 

Federal conflict of interest provisions 

are directed toward the potential for 

conflict of interest on the part of FDA 

employees and outside experts used on 

FDA’s advisory committees (see 5 CFR 

2640 and 18 U.S.C. 208). 

FDA defines valid scientific evidence 

in § 860.7(c)(2). Isolated case reports, 

random experience, and 

unsubstantiated opinions are not 

regarded as valid scientific evidence. In 

standard clinical practice as in ECT 

treatment, healthcare professionals are 

compensated for providing treatment to 

patients. Institutional review boards 

assess potential conflicts of interest for 

healthcare professionals conducting 

clinical research on ECT. Under 21 CFR 

part 54, FDA assesses potential financial 

conflicts of interest for healthcare 

professionals conducting clinical 

research on ECT. Scientific journals 

typically require disclosure of funding 

and potential conflicts of interest when 

publishing research findings. 

(Comment 15) Several comments were 

concerned about the benefit-risk ratio 

for ECT treatment. Comments raised 

concerns that the risks of ECT may be 

higher in vulnerable populations, 

including the elderly, who could have 

hemorrhaging from increased 

intracranial pressure, pregnant women, 

and patients with multiple disorders, 

cancer, or multiple medications. 

Comments indicated that the risks of 

ECT are higher than acknowledged 

because adverse reactions are 

mischaracterized so that they are not 

associated with ECT. Comments also 

expressed concern that patient-reported 

outcomes differ from reported adverse 

events and study outcomes. Comments 

said some adverse effects of ECT, such 

as emotional trauma, have had limited 

scientific study but are evidenced by 

many subjective patient accounts and 

should be considered further. 

Comments noted that the benefit-risk 

ratio could change over the course of an 

ECT treatment. Comments said the 

benefit could decrease and the risks 

could increase because higher 

stimulation is needed for effectiveness 

over the course of treatment, leading to 

a higher risk of adverse events. In 

addition, comments said the repeated 

use of general anesthesia for ECT over 

a relatively short period of time could 

increase the risk of side effects. 

(Response 15) FDA believes there is 

reasonable assurance that with the 

special controls codified in the final 

order, in combination with general 

controls, the benefit of ECT outweighs 

the risk for the indicated populations 

whose condition is treatment-resistant 

or who require a rapid response due to 

the severity of their psychiatric or 

medical condition. The practitioner 

administering ECT is responsible for 

ongoing medical management and 

disclosure of changes in the risks for 

individual patients during a course of 

ECT treatment. In considering the 

benefits and risks, FDA took into 

consideration all available information, 

including the existing published 

scientific literature, practice guidelines 

published by major psychiatric and lay 

mental health organizations, input from 

the external classification panel, and 

reports of adverse events contained in 

the MAUDE database. Based upon all of 

this information, FDA has determined 

that the probable benefits to health from 

use of the device outweigh the probable 

risks for the class II indications and, 

furthermore, the risks associated with 

the use of ECT for the class II 

indications can be mitigated with the 

proposed special controls. 

(Comment 16) Several comments 

indicated that the special controls were 

inadequate to properly mitigate severe 

risks such as the risk of cognitive 

impairment and death. Comments 

indicated that special controls cannot be 

developed for unknown risks. For 

example, it is not known whether ECT 

patients return to baseline memory 

functioning after 6 months. A comment 

asserts that FDA must use scientific 

evidence to evaluate risk to memory and 

it is not enough for FDA ‘‘to believe’’ the 

potential benefits of ECT outweigh the 

risk of memory impairment. The 

comment also indicates that FDA 

presents no evidence verifying that the 

special controls are effective at 

mitigating risk or that the special 

controls will ensure patients understand 

the benefits-risks of ECT. 

(Response 16) FDA identified 

sufficient scientific information to 

establish special controls, including 

adequate instructions for use and 

appropriate precautionary language. The 

special controls along with general 

controls provide a reasonable assurance 

that ECT can be used safely and 

effectively for the indications being 

reclassified to class II. Regarding the use 

of the word, believe, by FDA in the 

proposed order, FDA’s use is of the 

word believe is a term of art to indicate 

its current understanding of an issue in 

administrative orders. The term, believe, 

is also used in both the FD&C Act and 

FDA’s regulations. 

The risk of memory impairment 

following ECT treatment is addressed in 

the special controls. The risk of 

cognitive and memory impairment can 

be mitigated by establishing the 

technical parameters for the device 

along with non-clinical testing data to 

confirm the electrical characteristics of 

the output waveform. The existing 

clinical performance data for ECT in 

treating catatonia or a severe MDE 

associated with MDD or BPD provides 

evidence that the cognitive impairment 

and related effects are transient (Refs. 5 

and 34) and supports a reasonable 

assurance of SE. This risk is further 

mitigated by providing information to 

both the user and patient, in the form of 

labeling, on the potential adverse effects 

of the device, alternative treatments, 

and a prominent warning that ECT 

device use may be associated with: 

disorientation, confusion, and memory 

problems and is limited in its long-term 

effectiveness (greater than 3 months). 

These risks can also be mitigated by 

providing instructions to the user that 

include recommendations on cognitive 

status monitoring prior to beginning 

ECT and during the course of treatment. 

Providing this information helps 

patients and healthcare professionals to 

make informed choices about how and 

when to use ECT to maximize benefits 

and minimize potential adverse effects. 

D. Comments on Regulatory Process of 

the Proposed Order 

In this section, comments on process 

concerns of the order are categorically 

grouped together so that the responses 

could be addressed by topic instead of 


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each comment considered 

independently. 

(Comment 17) Several comments 

provided recommendations on 

additional sources of information that 

FDA should consider in regards to 

reclassification of ECT. Comments 

suggested that FDA should review State 

ECT registries for information on use 

and outcomes. Comments suggested 

FDA should require new clinical trials, 

additional postmarket surveillance, and/ 

or establish patient registries for the 

purposes of: (1) Establishing long-term 

risks, such as the potential for shortened 

life; (2) monitoring and assessing 

memory and cognitive functioning over 

a period of a year or more to determine 

if memory loss is permanent; and (3) 

determining if patients experienced any 

long-term benefit. A comment indicates 

that MDR data should be used in the 

classification determination for ECT. 

The comment attaches an analysis of the 

FDA MDR database search showing that 

most patients report lasting memory and 

cognition impairment, and other side 

effects that affect work, education, and 

social relationships. The comment 

indicates that FDA’s MDR database 

shows systematic discrepant reporting 

of ECT adverse events (e.g., description 

of burns coded with event type, 

malfunction). Comments requested that 

FDA hold another public meeting about 

the classification of ECT that includes 

testimony from ECT patients because of 

the ‘‘new information’’ provided in the 

public comments. 

(Response 17) FDA agrees that State 

or national registries may play a role in 

medical device surveillance to provide 

additional detailed information about 

patients, procedures, and devices not 

routinely collected by electronic health 

records and administrative or claims 

data. The State of Texas has for several 

years maintained a registry of all ECT 

treatments in the State in a given year. 

Data on these treatments are provided in 

an annual report to the governor (see 

https://www.dshs.texas.gov/mhsa/ 

bhmd/ect/, Ref. 55). The most recent 

report provides data for fiscal year 2016. 

This report summarizes 17,006 

treatments given to 2,675 patients. 

Severe complications included 0 

fractures, 0 episodes of apnea, 0 cases of 

cardiac arrest without death, and 1 

death within 14 days of treatment that 

was reported to be the result of a drug 

overdose. This report concludes that, 

overall, patients experienced less severe 

symptomology after ECT treatment, 

which demonstrates the overall 

effectiveness of treatment. These data 

are consistent with the published 

literature and do not provide ‘‘new 

information’’ that would change the 

recommendation in the final order. 

FDA requires manufacturers to submit 

MDRs of adverse events when their 

device may have caused or contributed 

to a death, serious injury, or in certain 

situations when their device has 

malfunctioned. FDA acknowledges that 

there are limitations to the use of MDR 

reports for determining the cause and 

frequency of adverse events. Confirming 

whether a device caused a specific event 

can be difficult based solely on 

information provided in a given MDR 

report. Establishing a cause-and-effect 

relationship is especially difficult if 

circumstances surrounding the event 

have not been verified or if the device 

in question has not been directly 

evaluated. FDA does not typically have 

complete information on the number of 

times devices of a certain type are used 

from which to calculate adverse event 

rates. MDR data does not represent all 

known safety information for a medical 

device and should be interpreted in the 

context of other available information 

when making device-related or 

treatment decisions. Healthcare 

professionals, patients, caregivers, and 

consumers are encouraged to submit 

voluntary reports detailing treatment 

parameters and outcomes to MedWatch: 

The FDA Safety Information and 

Adverse Event Reporting Program, for 

serious adverse events that may be 

associated with a medical device, as 

well as use errors, product quality 

issues, and therapeutic failures (Ref. 56). 

Reports of adverse events are monitored 

by FDA for safety signals that may 

warrant changes to device regulation. 

Despite the limitations of MDR data 

described above, as part of its review of 

the comments submitted to the ECT 

public dockets, FDA conducted an 

updated review of the MDR database 

covering the period from February 2011 

through December 2017. This review 

identified an additional 27 reports, all of 

which are voluntary reports. No reports 

for individuals less than 18 years of age 

were reported to the MDR database. 

Similar to the reports included in the 

Executive Summary for the 

classification panel, the most commonly 

cited adverse event type was cognitive 

changes, notably memory loss (52 

percent). Other commonly reported 

adverse events included general 

emotional/psychiatric (e.g., anxiety, 

emotional changes), general motor (e.g., 

shaking/tremors), and four reports of 

either tissue damage (not specified) or 

burns. Thus, FDA concluded that no 

new types of adverse events have been 

identified that would warrant changes 

to the proposed reclassification order. 

(Comment 18) Several comments 

raised concern with how the ECT 2011 

classification panel was conducted. 

Several comments indicated that the 

proposed reclassification was not 

supported by the panel, because the 

classification panel did not reach 

consensus regarding whether any of the 

indications should be class II. 

Comments said that FDA 

misrepresented the classification panel 

results regarding consensus on 

classification of ECT. Another comment 

alleges that FDA improperly influenced 

the makeup and deliberations of the 

classification panel. 

(Response 18) FDA considers the 

deliberations as well as the 

recommendations by the classification 

panel meeting in determining the 

appropriate classification of a device 

under section 513(a) of the FD&C Act. 

The classification panel discussions and 

recommendations are considered as part 

of FDA’s decision whether to revise 

classification of a device (see section 

515(i)(2) of the FD&C Act). Although the 

panel provides recommendations with 

respect to the classification of devices, 

FDA is also not required to follow the 

classification panel recommendations. 

Regarding ECT, the panel did not reach 

a consensus on its classification for any 

of the proposed conditions for 

reclassification. There were a variety of 

opinions and judgments provided both 

in support of and in opposition to 

reclassification. The opinions expressed 

by the classification panel were 

carefully reviewed and considered along 

with other information including 

professional organization practice 

guidelines, MDR reports, and published 

scientific studies. 

Based on this evidence from multiple 

sources, FDA has determined that 

special controls, in combination with 

general controls, establish a reasonable 

assurance of SE by mitigating the risks 

associated with ECT for the uses being 

reclassified (as discussed in section X, 

80 FR 81223 at 81230, December 29, 

2015). In accordance with section 

515(i)(2) of the FD&C Act, based on 

valid scientific evidence with respect to 

the device and taking into account the 

public health benefit(s) of the use of the 

device and the nature and known 

incidence of the risk(s) of the device, 

FDA is also now revising the 

classification of ECT for treatment of 

catatonia or a severe MDE associated 

with MDD or BPD who are treatmentresistant or who require a rapid 

response due to the severity of their 

psychiatric or medical condition in 

patients ages 13 years and older, from 

class III to class II (special controls) (see 

subsections A and B of this section). 


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FDA disagrees with the comment that 

FDA improperly influenced the 2011 

classification panel. On January 27–28, 

2011, FDA held a meeting of the 

Neurological Devices Classification 

Panel to discuss the classification of 

ECT devices for treatment of several 

disorders. FDA has standard procedures 

in place for establishing a classification 

panel meeting consistent with the 

requirements of the Federal Advisory 

Committee Act, other relevant statutes 

(e.g., the FD&C Act), regulations (e.g., 21 

CFR 14.25 and 14.29), and Agency 

guidance. As required for all 

classification panel meetings, FDA 

conducted the proper screening and 

vetting of classification panel members 

for the 2011 Panel meeting. FDA 

ensured the classification panel 

included representatives with expertise 

in several relevant mental health 

disciplines. The ECT classification 

panel meeting meets the requirement 

under section 513(b)(1) of the FD&C Act 

for a device classification panel 

meeting. 

The conduct of the 2011 Panel 

meeting is described in the transcript of 

the meeting and the 24 Hour Summary 

(Ref. 57). FDA presented the general 

regulatory background, brief clinical 

history of ECT use, and ECT-specific 

regulatory history. This was followed by 

an open public hearing. Then, FDA 

presented the FDA’s safety analysis, 

which included a review of responses to 

a public docket on ECT reclassification, 

manufacturer docket responses, and an 

adverse event database review. In 

addition, FDA presented a focused 

review of specific adverse events, 

including cognitive and memory 

adverse events, neuropathological 

changes, and death. Following the safety 

review, FDA presented a review of the 

effectiveness of ECT. The classification 

panel then proceeded to their 

deliberations regarding the questions 

posed by FDA. The classification panel 

agreed that the list of risks provided by 

FDA were appropriate for inclusion 

with some minor modifications and 

deletions. The classification panel 

recommended physician labeling for 

pre-ECT assessment, including pertinent 

history, physical examination, other 

clinically relevant studies, appropriate 

procedure monitoring and 

administration, and appropriate clinical 

management. When presented with 

potential regulatory controls that FDA 

could apply to ECT to mitigate risks of 

adverse cognitive and memory effects, 

especially with respect to anterograde 

and retrograde memory functioning, the 

classification panel agreed that 

cognitive function should be monitored 

prior to ECT and throughout the course 

of treatment. The classification panel 

agreed that the existing clinical data do 

not provide evidence that ECT treatment 

is associated with neuropathological 

changes. Finally, the classification panel 

provided overall recommendations for 

the class II or III classification of ECT 

devices for specific indications for use, 

including depression (unipolar and 

bipolar), schizophrenia, bipolar manic 

(and mixed) states, schizoaffective 

disorder and schizophreniform disorder, 

and catatonia. There was classification 

panel consensus recommending class III 

for schizophrenia, bipolar manic states, 

and schizoaffective and 

schizophreniform disorder. The 

classification panel did not reach 

consensus on the classification of ECT 

for depression (unipolar and bipolar) 

and catatonia. 

(Comment 19) Several comments 

related to the information used to 

support reclassification. Several 

comments indicated that the scientific 

evidence, medical studies, metaanalyses and literature reviews cited in 

the proposed order do not constitute 

new evidence or reinterpret previously 

published evidence and are insufficient 

to justify the reclassification. Comments 

say FDA ignored the 2010 meta-analysis 

from Read and Bentall that found, after 

reviewing hundreds of studies, no 

evidence that ECT treatment had any 

benefit for any population lasting 

beyond a few days and did not prevent 

suicide. 

(Response 19) In accordance with 

section 515(i)(2) of the FD&C Act, FDA 

is reclassifying the ECT device from 

class III to II (special controls) for use in 

treating catatonia or a severe MDE 

associated with MDD or BPD in patients 

age 13 years and older who are 

treatment-resistant or who require a 

rapid response due to the severity of 

their psychiatric or medical condition. 

FDA has made this reclassification 

decision based on FDA’s evaluation of 

the following sources of information: (1) 

Published literature referenced in the 

Executive Summary to the 2011 Panel; 

(2) comments and literature received in 

the ECT public dockets, as discussed 

above; (3) clinical practice guidelines; 

(4) review of MDRs in the FDA MAUDE 

database); and (5) the additional post2011 scientific information that was 

provided to FDA in comments to the 

2015 proposed order. Based on FDA’s 

evaluation of the totality of the evidence 

under the criteria set forth in section 

513(a) of the FD&C Act, FDA believes 

that there is valid scientific evidence to 

support FDA’s decision to reclassify the 

ECT device from class III to II (special 

controls) for the intended uses 

described previously. 

FDA disagrees with the conclusions of 

the 2010 Read and Bentall analysis. 

Specifically, FDA conducted an 

independent review and several 

publications, as well as reviews of the 

published literature, support the use of 

ECT in treating catatonia or a severe 

MDE associated with MDD or BPD in 

patients age 13 years and older who are 

treatment-resistant or who require a 

rapid response due to the severity of 

their psychiatric or medical condition 

(Ref. 33, 34 and 58–60). Observations 

from these individual studies, 

retrospective reviews, and metaanalyses consistently reported favorable 

SE clinical outcomes for the indications 

being reclassified by this final order. In 

addition, as part of the preparations for 

the 2011 Classification Panel Meeting, 

FDA conducted a systematic review of 

the scientific literature regarding the SE 

of ECT for a variety of psychiatric 

conditions. FDA conducted a metaanalysis of the data provided in all 

studies that met criteria for inclusion in 

this systematic review. Based upon this 

review and meta-analysis, and the 

totality of evidence, FDA determined 

that there was reasonable assurance of 

the SE of ECT for the class II indications 

in this final order. 

(Comment 20) Several concerns were 

raised about the process for the 

proposed order. Comments indicated 

the guidance should not be used or 

issued prior to finalization of the final 

order. Comments indicated there was 

inadequate time to comment on the 

proposed order due to timing of the 

comment period coinciding with 

holidays at the end of the year, and 

weekends being included in the 90-day 

response time. Comments indicated that 

two dockets (one for the proposed order 

and one for the draft guidance) on ECT 

made commenting more difficult. 

Commenters objected to elimination of 

mass mail in campaigns and duplicative 

or near-duplicative letters. 

(Response 20) FDA agrees with the 

comment that guidance should not be 

used or issued prior to finalization of 

the final order. Final guidance will not 

be issued prior to issuance of the final 

order. FDA believes the correct process 

was followed for the proposed order 

issued for ECT. FDA determined it was 

beneficial to publish the proposed order 

and draft guidance on ECT concurrently 

to ensure that all relevant information 

pertinent to the potential 

reclassification of ECT, along with a 

recommended strategy for 

demonstrating substantial equivalence 

for ECT devices subject to 510(k), was 

available to the public at the same time. 


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FDA believes that a 90-day comment 

period was ample time to allow the 

public to comment on the proposed 

order and concurrently released draft 

guidance and is consistent with the 

timeframes for other classification and 

reclassification efforts. Commenting on 

two dockets related to ECT rather than 

one docket does require additional effort 

by commenters. However, FDA had 

taken two different actions related to 

ECT (proposing a reclassification and 

issuing draft guidance), such that two 

dockets were made available to provide 

the option of commenting on one or 

both of these proposed actions. 

Documents that are in ‘‘draft’’ form are 

not implemented by FDA unless and 

until finalized. 

Information submitted as part of a 

mass campaign was also reviewed. 

However, while the content of these 

letters is considered and responded to, 

FDA does not individually respond to 

the same information contained in mass 

campaign letters and duplicative letters. 

This allows FDA to efficiently utilize 

resources when reviewing comments. 

As noted previously, although over 

3,400 comments were received, 

comments were categorically grouped 

together so that responses are addressed 

by topic instead of responding 

independently to each individual 

comment. 

(Comment 21) Several comments 

argue that the terms ‘‘treatment 

resistant’’ and ‘‘require rapid response’’ 

are vague, particularly to non-clinicians. 

Several comments asked for clarification 

on the number and types of treatments, 

as well as the duration of treatment that 

should be tried prior to being labeled 

treatment-resistant. Several comments 

indicated that there was not consensus 

from the literature and professional 

organizations on the meaning of 

treatment-resistant. A comment 

indicates that defining treatmentresistant depression as the failure of two 

antidepressants is not appropriate 

because antidepressants are not effective 

for every patient and there are other 

treatments that may be effective that 

should be used prior to ECT. Several 

comments indicated that psychotherapy 

or other non-medical treatments should 

be tried prior to ECT. Several comments 

were concerned that the lack of clarity 

of these terms would lead to misuse of 

ECT. Several other comments indicated 

that the terms ‘‘treatment-resistant’’ and 

‘‘require rapid response’’ were well 

understood and described in applicable 

medical literature and the Diagnostic 

and Statistical Manual of Mental 

Disorders (Ref. 61). 

(Response 21) FDA identifies the 

intended population in which ECT is 

classified in class II as patients who are 

treatment-resistant because ECT is not a 

currently established first-line 

treatment, except when rapid response 

is needed due to the severity of the 

patient’s psychiatric or medical 

condition. FDA acknowledges that these 

terms may not be entirely clear to 

patients. However, comments by 

healthcare professionals generally 

indicated that the terms are well 

understood by the staff who would be 

prescribing or using this therapy. The 

need for rapid response and the criteria 

for treatment-resistant can be based on 

clinical judgment. The information on 

the intended patient population that, as 

part of the special controls, must be 

listed on the device label 

(§ 882.5940(b)(1)(viii)(D)) is directed 

toward the practitioner licensed by law 

to administer or use the device. 

(Comment 22) A comment asks FDA 

to delete the recommendation in 

§ 882.5940(b)(1)(viii)(B)(7) for ‘‘formal 

neuropsychological assessment’’ from 

the labeling because it is not the norm 

and would create barriers to the 

availability and timeliness of care in 

that such assessments are costly and 

difficult to access. 

(Response 22) FDA recognizes that 

not all ECT practitioners have access to 

neuropsychologists who conduct formal 

neuropsychological assessment. 

However, FDA believes that the known 

risk of cognitive adverse events can be 

mitigated by the special controls that 

require user instructions recommending 

cognitive status monitoring prior to 

beginning ECT and throughout the 

course of treatment via a formal 

neuropsychological assessment. If 

cognitive abilities decline during the 

course of treatment, steps can be taken 

to avoid further decline. 

(Comment 23) A comment stated 

depression is sometimes associated with 

cognitive problems and urges FDA to 

require that all providers of ECT assess 

patients’ cognitive and memory 

functioning when they first become 

patients before ECT begins, soon after 

ECT ends, and at longer term followup 

after ECT treatment. 

(Response 23) FDA includes a special 

control (§ 882.5940(b)(1)(viii)(B)(7)) that 

requires user instructions that 

recommend cognitive status monitoring 

prior to beginning ECT and during the 

course of treatment via formal 

neuropsychological assessment for 

evaluating specific cognitive functions 

(e.g., orientation, attention, memory, 

and executive function). FDA 

acknowledges that autobiographical 

memory loss following ECT treatment 

can occur, so this adverse event has 

been included in the labeling for ECT. 

FDA also acknowledges that the ‘‘longterm safety and effectiveness of ECT 

treatment has not been demonstrated,’’ 

and therefore has included this risk as 

a warning in the ECT device labeling 

that long-term followup may be needed. 

E. Comments on Labeling Concerns 

In this section, comments on labeling 

concerns in using ECT are categorically 

grouped together so that the responses 

could be addressed by topic instead of 

each comment considered 

independently. 

(Comment 24) A comment requested 

that FDA delete the proposed warning 

in § 882.5940(b)(1)(viii)(J) and (ix)(G) 

(‘‘When used as intended this device 

provides short-term relief of symptoms. 

The long-term safety and effectiveness 

of ECT treatment has not been 

demonstrated.’’) because it is 

understood that cessation of active 

treatment will be associated with 

cessation of treatment benefits. 

(Response 24) Based upon all 

available evidence and FDA’s own 

analysis of the published scientific 

literature, FDA concluded that the longterm SE of ECT has not been 

demonstrated. However, FDA 

recognizes that ECT healthcare 

professionals often conduct longer term 

treatment strategies with ECT. The 

reclassification of ECT does not 

specifically address the issue of 

maintenance or continual ECT, which 

would be at the discretion of the 

healthcare professional. However, as 

described in the special controls, results 

from longer term performance data 

should be considered for inclusion in 

the healthcare professional and patient 

labeling, if warranted. 

(Comment 25) A comment asks FDA 

to replace the word ‘‘contraindications’’ 

in proposed § 882.5940(b)(1)(ix)(A) with 

the phrase ‘‘conditions associated with 

substantially increased risk’’ because 

describing these conditions as 

contraindications is likely to restrict 

access to needed ECT in very rare but 

life-threatening situations. 

(Response 25) The use of the word 

‘‘contraindications’’ here refers 

specifically to medical conditions other 

than psychiatric disorders in which the 

use of ECT has been demonstrated to 

result in serious adverse events, some of 

which might be life-threatening. These 

include unstable cardiac and pulmonary 

conditions (e.g., recent heart attack, 

asthma, pneumonia) and history of 

neurological conditions (e.g., stroke, 

tumors, increased pressure in the brain). 

Contraindications are defined as 

situations in which the device should 

not be used because the risk of use 

clearly outweighs any benefit. (Ref. 62). 


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Therefore, FDA believes it is 

appropriate to keep the language as 

initially written in the proposed order. 

(Comment 26) A comment disagrees 

with definitions of short-term and longterm memory in 

§ 882.5940(b)(1)(ix)(H)(1). The comment 

says equating short-term to anterograde 

memory loss and long-term to 

autobiographical memory loss is 

unusual in the psychiatric field and 

confusing for patients. The comment 

says short-term could mean: (1) Lasting 

for a short period before returning; (2) 

affecting short-term memory, i.e., the 

type of memory where information is 

held onto for a few seconds to a few 

minutes; or (3) anterograde memory, 

which is the ability to form new 

memories. The comment says this 

labeling does not clearly describe the 

range of deficits that patients might 

experience. The comment says there is 

a similar lack of clarity in the use of the 

term ‘‘long-term’’. The comment says 

long-term memory typically includes 

many different types of information 

storage, stored for an extended period of 

time that could range from more than a 

few minutes to years. The comment says 

many types of cognitive problems can 

occur following ECT in addition to 

anterograde verbal memory and 

retrograde autobiographical memory, 

including retrograde loss of nonpersonal, non-rote information (such as 

knowledge used in daily work tasks), 

and impairments in working memory, 

processing speed, attention, and 

executive function. The comment also 

indicates that there are discrepancies 

within the order on the definition of 

long-term, which is defined as 1 month 

in some instance and as 3 months in 

other instances. 

(Response 26) FDA recognizes that 

there are a variety of terms used in the 

scientific literature with respect to 

memory function. The multiple 

descriptions and definitions of various 

memory functions such as ‘‘short-term’’ 

or ‘‘long-term’’ memory contributes to 

significant confusion both among 

healthcare professionals and lay 

persons. FDA will require the inclusion 

of the following in the labeling: ‘‘ECT 

treatment may be associated with 

disorientation, confusion and memory 

loss, including short-term (anterograde) 

and long-term (autobiographical) 

memory loss following treatment. These 

side effects tend to go away within a few 

days to a few months after the last 

treatment with ECT. However, some 

patients have reported a permanent loss 

of memories of personal life events (i.e., 

autobiographical memory).’’ In addition, 

because of the complexity of memory 

loss, cognitive status monitoring prior to 

beginning ECT and during the course of 

treatment via formal neuropsychological 

assessment for evaluating specific 

cognitive functions (e.g., orientation, 

attention, memory, executive function) 

is included as a special control. 

(Comment 27) A comment asks FDA 

to change the proposed labeling by 

deleting from the list of known risks the 

phrase, ‘‘a worsening of the psychiatric 

symptoms they are being treated for,’’ in 

§ 882.5940(b)(1)(ix)(H)(2). The comment 

notes symptoms may worsen if ECT is 

not effective but argues that this is not 

the same as saying that symptoms 

worsen as a known risk of ECT. The 

comment notes that the possibility of 

precipitating a manic episode with ECT 

treatment is documented in the 

scientific literature but is already 

included in the listing of potential risks. 

(Response 27) FDA recognizes that 

worsening of an underlying medical 

condition can occur either by: (1) An 

ineffective treatment or (2) the treatment 

itself, particularly when it exacerbates 

the symptoms. Without additional 

scientific evidence to distinguish 

between these two causes for the use of 

ECT, this language is included as a 

potential risk. 

(Comment 28) Several comments 

indicated that labeling was not a 

sufficient mitigation for the risks 

associated with ECT. Several comments 

indicated that labeling was not a 

sufficient mitigation because the label 

might not be read, understood, or 

followed. 

(Response 28) FDA notes that 

regardless of the classification and the 

risk presented by medical devices, they 

have the potential to cause harm to 

patients if the labeling is not read, 

understood, or followed. FDA has 

purposefully included, per the special 

controls, specific mitigations in the 

required labeling to ensure patient 

protections and transparency related to 

the benefit-risk profile of ECT. Labeling 

directed to healthcare professionals and 

patients further help to mitigate the 

risks of ECT because it must include 

instructions for use and a description of 

the known risks. 

(Comment 29) A comment asks FDA 

to delete in § 882.5940(b)(1)(ix)(H)(3)(v) 

the phrase ‘‘insufficient, or lack of 

breathing’’ as a pulmonary complication 

and add a new item ‘‘prolonged action 

of anesthetic agents associated with 

insufficient or lack of breathing.’’ The 

comment says the proposed text implies 

that insufficient or lack of breathing 

may be a long-term complication of 

ECT, whereas apnea is an expected 

effect of neuromuscular blocking agents. 

The comment notes insufficient or lack 

of breathing may be prolonged in some 

individuals but can be addressed 

through continued ventilation and 

oxygenation by an anesthesia provider. 

(Response 29) FDA agrees that the 

warnings related to pulmonary risks 

were unclear and has revised 

§ 882.5940(b)(1)(ix)(H)(3)(v) to identify 

these pulmonary risks associated with 

the use of general anesthesia and 

neuromuscular blocking agents. 

F. Comments Outside of the Scope of 

This Final Order 

There were several comments 

submitted that were outside the scope of 

this Final Order and in this section we 

explain why. Also, in this section 

comments are categorically grouped 

together so that the responses are by 

topic. 

(Comment 30) A number of comments 

recommended that FDA take action to 

not allow the American Psychiatric 

Association (APA) to use the phrase 

‘‘safe, effective treatment’’ and to 

prevent the APA and the National 

Institute for Mental Health from 

explicitly using some of the claims on 

ECT treatment. 

(Response 30) FDA generally does not 

have the authority to direct medical 

associations and other government 

agencies on how to phrase their 

scientific evaluation of medical devices. 

Therefore, the requests are outside the 

scope of this final order. 

(Comment 31) Several comments 

raised concerns regarding insurance 

coverage with different indications in 

different regulatory classes. Several 

comments indicated that coverage 

issues may reduce patient options for 

treatment. 

(Response 31) FDA has no authority 

over commercial health insurance 

carriers. Under section 513(e) of the 

FD&C Act, FDA has no authority to 

consider as part of a classification 

decision whether an indication or a 

device is covered by commercial health 

insurance companies. FDA recommends 

that patients check with their insurance 

company regarding coverage before 

receiving ECT treatment. 

(Comment 32) Some comments claim 

that ECT devices for specific intended 

uses are being reclassified for financial 

reasons and the Agency was influenced 

by the pharmaceutical industry in 

making its determination. A comment 

also asked FDA to provide reparations 

for ECT patients. 

(Response 32) As stated previously in 

this section, FDA based its 

determination of reclassification of ECT 

devices for use in treating catatonia or 

a severe MDE associated with MDD or 

BPD to class II (special controls) on 

valid scientific evidence, including the 


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classification panel recommendations, 

evaluation of scientific literature, 

clinical practice guidelines, and 

comments submitted to the ECT public 

dockets. These comments and the 

request for reparations are outside the 

scope of this final order. 

(Comment 33) A comment claimed 

that there is discriminatory use of ECT 

including in women, people of color, 

elderly, and economically struggling 

patients. Another comment stated that 

many people are receiving ECT 

treatment out of desperation. 

(Response 33) FDA understands the 

concerns of possible discriminatory 

actions by sub-populations in the 

treatment of ECT and possible treatment 

out of desperation; however, these 

comments are outside the scope of this 

final order in determining the 

classification of ECT devices. 

(Comment 34) A comment stated that 

the advertising of ECT devices directed 

at consumers promotes ‘‘risk-taking 

behavior.’’ 

(Response 34) This is also outside the 

scope of this final order in determining 

the classification of ECT devices. 

Under the FD&C Act, FDA has 

regulatory authority over the labeling of 

medical devices (21 CFR part 801). 

However, FDA’s regulation of medical 

device advertising is limited to a subset 

of restricted medical devices, which 

ECT is not. The Federal Trade 

Commission regulates the advertising, 

as opposed to the labeling, of most 

medical devices under sections 12–15 of 

the Federal Trade Commission Act, 

which prohibit false or misleading 

advertising of certain products that FDA 

regulates (15 U.S.C. 52–55). 

IV. The Final Order 

Under section 515(b) and (i) of the 

FD&C Act, FDA is adopting, in part, its 

findings as published in the preamble to 

the proposed order. For the reasons 

described previously in section II, FDA 

has made revisions in this final order in 

response to comments submitted in the 

ECT public dockets and information 

received on the proposed order. The 

revisions modify the ECT class II 

classification to also reclassify ECT 

devices used for the treatment of 

catatonia into class II. The revisions 

further modify the ECT class II 

classification by changing the 

requirement that the patient be ‘‘18 

years of age and older’’ to the 

requirement that the patient be ‘‘age 13 

years and older.’’ The revisions modify 

the ECT class III classification by 

removing the catatonia intended use. 

In response to comments, FDA also 

made some changes to the patient 

labeling special control requirement that 

addresses statements on the physical 

risks of ECT and additional age-related 

precautions. The patient labeling 

provides a list of physical risks, 

including pulmonary (affecting lungs) 

complications. FDA removes 

‘‘insufficient or lack of breathing’’ as a 

pulmonary complication and revised 

the complication list to include 

potential pulmonary complications of 

general anesthesia and neuromuscular 

blocking agents (muscle relaxants) given 

as part of ECT. FDA added language to 

clarify that the pulmonary risks of ECT 

include hypoxemia, hypoventilation, 

aspiration, and upper-airway 

obstruction (see 

§ 882.5940(b)(1)(ix)(H)(3)(v)). 

FDA separately considered the risk of 

the accessory electrodes as part of this 

classification (see § 882.5940(b)(1)(iii)). 

No other accessories are considered part 

of this classification. 

Section 510(m) of the FD&C Act 

provides that FDA may exempt a class 

II device from the premarket notification 

requirements under section 510(k), if 

FDA determines that premarket 

notification is not necessary to provide 

reasonable assurance of the SE of the 

device. For these ECT devices classified 

as class II, FDA has determined that 

premarket notification is necessary to 

provide reasonable assurance of the SE 

of the device. Therefore, this device 

type is not exempt from premarket 

notification requirements. Persons who 

intend to market this type of device 

must submit to FDA a premarket 

notification, prior to marketing the 

device, which contains information 

about the device they intend to market. 

Under section 515(i)(2) of the FD&C 

Act, FDA has the authority to issue an 

administrative order revising the 

classification of a device for which FDA 

has classified as a class III device and 

for which no administrative order has 

been issued calling for PMAs under 

section 515(b) of the FD&C Act, so that 

the device is classified into class I or 

class II, after issuance of a proposed 

order, a meeting of a device 

classification panel, and consideration 

of the comments on a proposed order. 

FDA published a proposed order to 

require the reclassification of ECT 

devices for intended uses specified in 

the proposed order and to require the 

filing of a PMA for ECT devices for 

other intended uses specified in the 

proposed order in the Federal Register 

of December 29, 2015. Moreover, as 

explained in section II of the proposed 

order, on January 27–28, 2011, FDA 

held a classification meeting of the 2011 

Panel to discuss classification of ECT 

devices for treatment of several 

disorders. FDA received and has 

considered all the comments received in 

response to all the ECT public dockets, 

including the proposed order, as 

discussed in section II. Therefore, FDA 

has met the requirements under sections 

515(b)(1) and 515(i)(2) of the FD&C Act. 

V. Implementation Strategy 

A. Date To File a PMA 

In accordance with section 515(b) of 

the FD&C Act, ECT devices indicated for 

schizophrenia, bipolar manic states, 

schizoaffective disorder, 

schizophreniform disorder, and 

catatonia or a severe MDE associated 

with MDD or BPD in patients under 13 

years who are treatment-resistant or 

who require a rapid response due to the 

severity of their psychiatric or medical 

condition must have a PMA or a notice 

of completion of a PDP filed with the 

Agency by March 26, 2019. An 

applicant whose device was legally in 

commercial distribution before May 28, 

1976, or whose device has been found 

to be substantially equivalent to such a 

device, will be permitted to continue 

marketing such class III devices during 

FDA’s review of the PMA provided that 

the PMA is timely filed. FDA intends to 

review any PMA for the device within 

180 days of the date of filing. FDA 

cautions that under section 

515(d)(1)(B)(i) of the FD&C Act, the 

Agency may not enter into an agreement 

to extend the review period for a PMA 

beyond 180 days unless the Agency 

finds that ‘‘the continued availability of 

the device is necessary for the public 

health.’’ 

Under § 812.2(d) (21 CFR 812.2(d)), 

the exemptions from the requirements 

of the IDE regulations for 

preamendments class III devices in 

§ 812.2(c)(1) and (2) will cease to apply 

to ECT devices indicated for 

schizophrenia, bipolar manic states, 

schizoaffective disorder, 

schizophreniform disorder, and 

catatonia or a severe MDE associated 

with MDD or BPD in patients that are 

under 13 years, or patients of any age 

who are not treatment-resistant or who 

do not require a rapid response due to 

the severity of their psychiatric or 

medical condition that are: (1) Not 

legally on the market on or before March 

26, 2019 or (2) legally on the market on 

or before March 26, 2019 but for which 

a PMA or notice of completion of a PDP 

is not filed by March 26, 2019, or for 

which PMA approval has been denied 

or withdrawn. 

If a PMA for a class III device is not 

filed with FDA by March 26, 2019, the 

device will be deemed adulterated 

under section 501(f) of the FD&C Act. 

The device may be distributed for 


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investigational use only if the 

requirements of the IDE regulations are 

met. The requirements for significant 

risk devices include submitting an IDE 

application to FDA for its review and 

approval. An approved IDE is required 

to be in effect before an investigation of 

the device may be initiated or continued 

under § 812.30. FDA, therefore, 

cautions that IDE applications should be 

submitted to FDA at least 30 days before 

March 26, 2019 to avoid interrupting 

investigations. 

B. Compliance With Special Controls 

Following the effective date of this 

final order, ECT devices intended for 

use in treating catatonia or a severe 

MDE associated with MDD or BPD in 

patients age 13 years and older who are 

treatment-resistant or who require a 

rapid response due to the severity of 

their psychiatric or medical condition 

must comply with the special controls. 

FDA notes that a firm whose ECT device 

was legally in commercial distribution 

before May 28, 1976, or whose device 

was found to be substantially equivalent 

to such a device and who does not 

intend to market such device for uses 

other than use in treating catatonia or a 

severe MDE associated with MDD or 

BPD in patients age 13 years and older 

who are treatment-resistant or who 

require a rapid response due to the 

severity of their psychiatric or medical 

condition, may remove such intended 

uses from the device’s labeling. 

The special controls identified in this 

final order are effective as of the date of 

publication of this order, December 26, 

2018. ECT devices intended for use in 

treating catatonia or a severe MDE 

associated with MDD or BPD in patients 

age 13 years and older who are 

treatment-resistant or who require a 

rapid response due to the severity of 

their psychiatric or medical condition 

must comply with the special controls 

following the effective date of this order. 

Manufacturers who wish to continue to 

legally market an ECT device for 

treatment of catatonia or a severe MDE 

associated with MDD or BPD in patients 

age 13 years and older who are 

treatment-resistant or who require a 

rapid response due to the severity of 

their psychiatric or medical condition 

must submit an amendment to their 

previously cleared 510(k) that 

demonstrates compliance with the 

special controls by June 24, 2019. 

Because FDA has modified the class II 

indications and the class II patient 

population from the proposed order, 

FDA is extending the time period for 

submitting an amendment to the 510(k), 

from 60 days to 180 days, to provide 

additional preparation time to submit a 

510(k) amendment. Such amendment 

will be added to the 510(k) file but will 

not serve as a basis for a new substantial 

equivalence review. A submitted 510(k) 

amendment in this context will be used 

solely to demonstrate to FDA that an 

ECT device is in compliance with the 

special controls. If a 510(k) amendment 

is not submitted by June 24, 2019 or if 

FDA determines that the amendment 

does not demonstrate compliance with 

the special controls, the device may be 

considered adulterated under section 

501(f)(1)(B) of the FD&C Act. 

For ECT devices that are not in class 

III as designated in this final order, that 

have not been legally marketed prior to 

December 26, 2018, or models that have 

been legally marketed but are required 

to submit a new 510(k) under 21 CFR 

807.81(a)(3) because the device is about 

to be significantly changed or modified, 

manufacturers must obtain 510(k) 

clearance, among other relevant 

requirements, and demonstrate 

compliance with the special controls 

included in this final order, before 

marketing the new or changed device. 

VI. Codification of Orders 

Section 515(b), as amended by 

FDASIA, and 515(i)(2) of the FD&C Act 

require FDA to issue final orders rather 

than regulations to reclassify devices. 

Therefore, FDA will continue to codify 

reclassifications and requirements for 

approval of an application for premarket 

approval, resulting from changes issued 

in final orders, in the Code of Federal 

Regulations. Accordingly, under section 

515(i)(2) of the FD&C Act, as amended 

by FDASIA, in this final order, we are 

codifying the reclassification of ECT 

devices for use in treating catatonia or 

a MDE associated with MDD or BPD in 

patients age 13 years and older who are 

treatment-resistant or who require a 

rapid response due to the severity of 

their psychiatric or medical condition 

into class II by amending § 882.5940. 

Further, we are codifying the 

requirement for approval of an 

application for premarket approval for 

ECT devices for the intended uses of 

schizophrenia, bipolar manic states, 

schizoaffective disorder, 

schizophreniform, and catatonia or a 

severe major depressive episode 

associated with MDD or BPD in patients 

under 13 years, or patients 13 years and 

older who are not treatment-resistant or 

who do not require a rapid response due 

to the severity of their psychiatric or 

medical condition, by amending the 

language in § 882.5940. 

VII. Analysis of Environmental Impact 

The Agency has determined under 21 

CFR 25.34(b) that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

VIII. Paperwork Reduction Act of 1995 

This final order refers to previously 

approved collections of information that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(PRA) (44 U.S.C. 3501–3520). The 

collections of information in part 807, 

subpart E, have been approved under 

OMB control number 0910–0120. The 

collections of information in part 812 

have been approved under OMB control 

number 0910–0078. The collections of 

information in 21 CFR part 814 have 

been approved under OMB control 

number 0910–0231. The collections of 

information in 21 CFR part 801 have 

been approved under OMB control 

number 0910–0485. 

The device and patient warning 

labeling provisions in this final order 

are not subject to review by OMB 

because they do not constitute a 

‘‘collection of information’’ under the 

PRA. Rather, the recommended labeling 

is a ‘‘public disclosure of information 

originally supplied by the Federal 

government to the recipient for the 

purpose of disclosure to the public’’ (5 

CFR 1320.3(c)(2)). 

IX. References 

The following references marked with 

an asterisk (*) are on display at the 

Dockets Management Staff (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852, and are available for viewing by 

interested persons between 9 a.m. and 4 

p.m., Monday through Friday; they also 

are available electronically at https://

www.regulations.gov. References 

without asterisks are not on public 

display at https://www.regulations.gov 

because they have copyright restriction. 

Some may be available at the website 

address, if listed. References without 

asterisks are available for viewing only 

at the Dockets Management Staff. FDA 

has verified the website addresses, as of 

the date this document publishes in the 

Federal Register, but websites are 

subject to change over time. 

* 1. FDA, ‘‘Medical Device Accessories— 

Describing Accessories and 

Classification Pathways; Guidance for 

Industry and Food and Drug 

Administration Staff.’’ December 20, 

2017. 

* 2. FDA, ‘‘Reclassification of Daily Wear 

Spherical Contact Lenses Consisting of 

Rigid Gas Permeable Plastic Materials; 


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Withdrawal of Proposed Rule.’’ 48 FR 

56778. 

* 3. FDA, ‘‘Use of Real-World Evidence to 

Support Regulatory Decision-Making for 

Medical Devices; Guidance for Industry 

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Staff.’’ August 31, 2017. 

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6. Kirov, G.G., et al., ‘‘Evaluation of 

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7. Maric, N.P., et al., ‘‘The Acute and 

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8. Spaans, H.P., et al., ‘‘Efficacy and 

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9. Semkovska, M., et al., ‘‘Bitemporal Versus 

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17. Jacob, P., et al., ‘‘Review of 

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20. Medda, P., et al., ‘‘Electroconvulsive 

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21. Raffin, M., et al., ‘‘Treatment Use in a 

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23. Shelef, A., et al., ‘‘Acute 

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24. Sienaert, P., et al., ‘‘A Clinical Review of 

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25. Unal, A., et al., ‘‘Effective Treatment of 

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pp. 206–269. 

26. Hasan, A., et al., ‘‘World Federation of 

Societies of Biological Psychiatry 

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Update 2012 on the Acute Treatment of 

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Treatment Resistance.’’ World Journal of 

Biologial Psychiatry, 2012. 13(5): pp. 

318–378. 

27. Ghaziuddin, N., et al., ‘‘Use of 

Continuation or Maintenance 

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Adolescents with Severe TreatmentResistant Depression.’’ Journal of ECT, 

2011. 27(2): pp. 168–174. 

28. Lima, N.N., et al., ‘‘Electroconvulsive 

Therapy Use in Adolescents: A 

Systematic Review.’’ Annals of General 

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29. Puffer, C.C., et al., ‘‘A 20 Year Practice 

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26(7): pp. 632–636. 

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31. Zhang, Z.J., et al., ‘‘Electroconvulsive 

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32. Cohen, D., et al., ‘‘Absence of Cognitive 

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33. Consoli, A., et al., ‘‘Electroconvulsive 

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34. Rey, J.M. and G. Walter, ‘‘Half a Century 

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35. Walter, G. and J.M. Rey, ‘‘An 

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36. Ghaziuddin, N., et al., ‘‘Electroconvulsive 

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37. Strober, M., et al., ‘‘Effects of 

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38. Cohen, D., et al., ‘‘Use of 

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1997. 13(1): pp. 25–31. 

39. Kutcher, S.R. and H.A. Robertson, 

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40. Ghaziuddin, N., et al., ‘‘Practice 

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* 41. FDA, Transcript of January 27–28, 2011, 

Meeting of the Neurological Devices 

Panel, Meeting to Discuss the 

Classification of Electroconvulsive 

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42. Baeza, I., et al., ‘‘Clinical Experience 

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43. Benzoni, O., et al., ‘‘Treatment of 

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Journal of Psychopathology, 2015. 21: 

pp. 266–268. 

44. Iancu, I., et al., ‘‘Patients with 

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Disorder Who Receive Multiple 

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45. Kristensen, D., et al., ‘‘Electroconvulsive 

Therapy for Treating Schizophrenia: A 

Chart Review of Patients from Two 

Catchment Areas.’’ European Archive of 

Psychiatry and Clinical Neurosciences, 

2011. 261(6): pp. 425–432. 

46. Levy-Rueff, M., et al., ‘‘Maintenance 

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47. Petrides, G., et al., ‘‘Electroconvulsive 

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48. Lehman, A.F., et al., ‘‘Practice Guideline 

for the Treatment of Patients with 

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161(2 Suppl): pp. 1–56. 

49. Black, D.W., et al., ‘‘ECT in Unipolar and 

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Evaluation of 460 Patients.’’ Convulsion 

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50. Mukherjee, S., et al., ‘‘Unmodified 

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Study.’’ Convulsion Therapy, 1992. 8(1): 

pp. 5–11. 

51. Small, J.G., et al., ‘‘Electroconvulsive 

Treatment Compared with Lithium in 

the Management of Manic States.’’ 

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45(8): pp. 727–732. 

52. Milstein, V., et al., ‘‘Does 

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2(1): pp. 3–6. 

* 53. United Nations General Assembly, 

‘‘Interim Report of the Special 

Rapporteur on Torture and Other Cruel, 

Inhuman or Degrading Treatment or 

Punishment.’’ 2008. 

* 54. U.S. Department of Health and Human 

Services. ‘‘Mental Health: A Report of 

the Surgeon General.’’ Rockville, MD: 

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profiles.nlm.nih.gov/ps/access/ 

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* 55. Texas Department of State Health 

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* 56. FDA, ‘‘MedWatch: The FDA Safety 

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** 57. FDA, ‘‘Neurological Devices Panel— 

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2011. 

58. Brown, E.D., et al., ‘‘Efficacy of 

Continuation/Maintenance 

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Depressive Episode in Adults with 

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Review.’’ Journal of ECT, 2014. 30(3): pp. 

195–202. 

59. de Sousa, R.T., et al., ‘‘Challenging 

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61. American Psychiatric Association, 

‘‘Diagnostic and Statistical Manual of 

Mental Disorders,’’ Fifth Edition, DSM– 

5. 2013. 

** 62. FDA, ‘‘Device Labeling Guidance 

#G91–1 (Blue Book Memo).’’ 1991. 

List of Subjects in 21 CFR Part 882 

Medical devices, Neurological 

devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 882 is 

amended as follows: 

PART 882—NEUROLOGICAL DEVICES 

■ 1. The authority citation for part 882 

continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 360l, 371. 

■ 2. Revise § 882.5940 to read as 

follows: 

§ 882.5940 Electroconvulsive therapy 

device. 

(a) Identification. An 

electroconvulsive therapy device is a 

prescription device, including the pulse 

generator and its stimulation electrodes, 

used for treating severe psychiatric 

disturbances by inducing in the patient 

a major motor seizure by applying a 

brief intense electrical current to the 

patient’s head. 

(b) Classification. (1) Class II (special 

controls) when the device is intended to 

treat catatonia or a severe major 

depressive episode (MDE) associated 

with major depressive disorder (MDD) 

or bipolar disorder (BPD) in patients age 

13 years and older who are treatmentresistant or who require a rapid 

response due to the severity of their 

psychiatric or medical condition. The 

special controls for this device are: 

(i) The technical parameters of the 

device, including waveform, output 

mode, pulse duration, frequency, train 

delivery, maximum charge and energy, 

and the type of impedance monitoring 

system must be fully characterized to 

ensure that the device performance 

characteristics are consistent with 

existing clinical performance data. 

(ii) Non-clinical testing data must 

confirm the electrical characteristics of 

the output waveform. 

(iii) Components of the device that 

come into human contact must be 

demonstrated to be biocompatible. 

(iv) Performance data must 

demonstrate electrical and mechanical 

safety and the functioning of all safety 

features built into the device including 

the static and dynamic impedance 

monitoring system. 

(v) Appropriate analysis/testing must 

validate electromagnetic compatibility. 

(vi) Appropriate software verification, 

validation, and hazard analysis must be 

performed. 

(vii) Performance data must 

demonstrate electrical performance, 

adhesive integrity, and physical and 

chemical stability of the stimulation 

electrodes. 

(viii) The labeling for the device must 

include the following: 

(A) Information related to generic 

adverse events associated with 

electroconvulsive therapy device (ECT) 

treatment; 

(B) Instructions must contain the 

following specific recommendations to 

the user of the device: 

(1) Conduct of pre-ECT medical and 

psychiatric assessment (including 

pertinent medical and psychiatric 

history, physical examination, 

anesthesia assessment, dental 

assessment, and other studies as 

clinically appropriate); 

(2) Use of patient monitoring during 

the procedure; 

(3) Use of general anesthesia and 

neuromuscular blocking agents; 

(4) Use of mouth/dental protection 

during the procedure; 

(5) Use of EEG monitoring until 

seizure termination; 

(6) Instructions on electrode 

placement, including adequate skin 

preparation and use of conductive gel; 

and 

(7) Cognitive status monitoring prior 

to beginning ECT and during the course 

of treatment via formal 

neuropsychological assessment for 

evaluating specific cognitive functions 

(e.g., orientation, attention, memory, 

executive function). 

(C) Clinical training needed by users 

of the device; 

(D) Information on the patient 

population in which the device is 

intended to be used; 

(E) Information on how the device 

operates and the typical course of 

treatment; 


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66124 Federal Register / Vol. 83, No. 246 / Wednesday, December 26, 2018 / Rules and Regulations 

(F) A detailed summary of the clinical 

testing, which includes the clinical 

outcomes associated with the use of the 

device, and a summary of adverse 

events and complications that occurred 

with the device; 

(G) A detailed summary of the device 

technical parameters; 

(H) Where appropriate, validated 

methods and instructions for 

reprocessing of any reusable 

components; 

(I) The following statement, 

prominently placed: ‘‘Warning: ECT 

device use may be associated with: 

disorientation, confusion, and memory 

problems’’; and 

(J) Absent performance data 

demonstrating a beneficial effect of 

longer term use, generally considered 

treatment in excess of 3 months, the 

following statement, prominently 

placed: ‘‘Warning: When used as 

intended this device provides shortterm relief of symptoms. The long-term 

safety and effectiveness of ECT 

treatment has not been demonstrated.’’ 

(ix) Patient labeling must be provided 

and include: 

(A) Relevant contraindications, 

warnings, precautions; 

(B) A summation of the clinical 

testing, which includes the clinical 

outcomes associated with the use of the 

device, and a summary of adverse 

events and complications that occurred 

with the device; 

(C) Information on how the device 

operates and the typical course of 

treatment; 

(D) The potential benefits; 

(E) Alternative treatments; 

(F) The following statement, 

prominently placed: ‘‘Warning: ECT 

device use may be associated with: 

Disorientation, confusion, and memory 

problems’’; 

(G) Absent performance data 

demonstrating a beneficial effect of 

longer term use, generally considered 

treatment in excess of 3 months, the 

following statement, prominently 

placed: ‘‘Warning: When used as 

intended this device provides shortterm relief of symptoms. The long-term 

safety and effectiveness of ECT 

treatment has not been demonstrated’’; 

and 

(H) The following statements on 

known risks of ECT, absent performance 

data demonstrating that these risks do 

not apply: 

(1) ECT treatment may be associated 

with disorientation, confusion and 

memory loss, including short-term 

(anterograde) and long-term 

(autobiographical) memory loss 

following treatment. Based on the 

majority of clinical evidence, these side 

effects tend to go away within a few 

days to a few months after the last 

treatment with ECT. Although the 

incidence of permanent cognitive 

memory loss was not supported by the 

clinical literature, some patients have 

reported a permanent loss of memories 

of personal life events (i.e., 

autobiographical memory); 

(2) Patients treated with ECT may 

experience manic symptoms (including 

euphoria and/or irritability, impulsivity, 

racing thoughts, distractibility, 

grandiosity, increased activity, 

talkativeness, and decreased need for 

sleep) or a worsening of the psychiatric 

symptoms they are being treated for; 

and 

(3) The physical risks of ECT may 

include the following (in order of 

frequency of occurrence): 

(i) Pain/somatic discomfort (including 

headache, muscle soreness, and nausea); 

(ii) Skin burns; 

(iii) Physical trauma (including 

fractures, contusions, injury from falls, 

dental and oral injury); 

(iv) Prolonged or delayed onset 

seizures; 

(v) Pulmonary complications 

(hypoxemia, hypoventilation, 

aspiration, upper-airway obstruction); 

(vi) Cardiovascular complications 

(cardiac arrhythmias, heart attack, high 

or low blood pressure, and stroke); and 

(vii) Death. 

(2) Classification: Class III (premarket 

approval) for the following intended 

uses: schizophrenia, bipolar manic 

states, schizoaffective disorder, 

schizophreniform disorder, and 

catatonia or a severe MDE associated 

with MDD or BPD in: 

(i) Patients under 13 years or 

(ii) Patients 13 years and older who 

are not treatment-resistant or who do 

not require a rapid response due to the 

severity of their psychiatric or medical 

condition. 

(c) Date premarket approval 

application (PMA) or notice of 

completion of product development 

protocol (PDP) is required. A PMA or 

notice of completion of a PDP is 

required to be filed with FDA on or 

before March 26, 2019, for any 

electroconvulsive therapy device with 

an intended use described in paragraph 

(b)(2) of this section, that was in 

commercial distribution before May 28, 

1976, or that has, on or before March 26, 

2019, been found to be substantially 

equivalent to any electroconvulsive 

therapy device with an intended use 

described in paragraph (b)(2) of this 

section, that was in commercial 

distribution before May 28, 1976. Any 

other electroconvulsive therapy device 

with an intended use described in 

paragraph (b)(2) of this section shall 

have an approved PMA or declared 

completed PDP in effect before being 

placed in commercial distribution. 

Dated: December 18, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–27809 Filed 12–21–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF JUSTICE 

28 CFR Part 2 

[Docket No. USPC–2018–03] 

Paroling, Recommitting, and 

Supervising Federal Prisoners: 

Prisoners Serving Sentences Under 

the United States and District of 

Columbia Codes 

AGENCY: United States Parole 

Commission, Justice. 

ACTION: Final rule. 

SUMMARY: The United States Parole 

Commission is revising a rule that 

authorizes the Chairman to delegate a 

Commissioner to conduct parole 

hearings. This procedural change will 

permit a Commissioner to conduct 

parole hearings and vote on the decision 

resulting from the proceeding, providing 

for a more efficient use of agency 

resources. 

DATES: This regulation is effective 

December 26, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Helen H. Krapels, General Counsel, U.S. 

Parole Commission, 90 K Street NE, 

Third Floor, Washington, DC 20530, 

telephone (202) 346–7030. Questions 

about this publication are welcome, but 

inquiries concerning individual cases 

cannot be answered over the telephone. 

SUPPLEMENTARY INFORMATION: The U.S. 

Parole Commission is revising its rule at 

28 CFR 2.59 that authorizes the 

Chairman to delegate a Commissioner to 

act as a Hearing Examiner, but 

disqualifies the Commissioner from 

voting in the case as a Commissioner 

during the proceeding. The authority of 

U.S. Parole Commissioners to conduct 

hearings and make decisions for 

offenders under the Commission’s 

jurisdiction is inherent in the 

Commission’s authority under 18 U.S.C. 

4203. Moreover, 18 U.S.C. 4203(c)(1) 

specifically authorizes the Commission 

to delegate to any Commissioner or 

commissioners the powers to grant or 

deny parole, impose conditions on an 

order granting parole, modify or revoke 

parole, etc. With the potential windingup of the agency in two years, having 


amozie on DSK3GDR082PROD with RULES