Document ID: FDA-2016-N-1111-1838
Agency: fda
Document Type: Rule
Title: Medical Devices; Petition for an Administrative Stay of Action: Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior
Posted Date: 2020-08-19T04:00Z

[Federal Register Volume 85, Number 161 (Wednesday, August 19, 2020)]
[Rules and Regulations]
[Pages 50950-50951]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16595]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 882 and 895

[Docket No. FDA-2016-N-1111]

Medical Devices; Petition for an Administrative Stay of Action: 
Electrical Stimulation Devices for Self-Injurious or Aggressive 
Behavior

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; notification of administrative stay.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is providing 
notice of a stay of the effectiveness of provisions for devices in use 
on specific individuals who have or would need to obtain a physician-
directed transition plan as of the date of publication on March 6, 
2020, of the final regulation banning electrical stimulation devices 
(ESDs) for self-injurious or aggressive behavior. FDA is publishing 
this notification in response to petitions for an administrative stay 
of action in accordance with regulatory requirements.

DATES: FDA is administratively staying temporarily the final regulation 
published on March 6, 2020 (85 FR 13312), for those devices in use on 
specific individuals as described in SUPPLEMENTARY INFORMATION. FDA 
will publish a document in the Federal Register lifting the stay or 
taking further action as needed.

ADDRESSES: For access to the docket, go to https://www.regulations.gov 
and insert the docket number, found in brackets in the heading of this 
document, into the ``Search'' box and follow the prompts and/or go to 
the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, 
MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Publicly 
available submissions may be seen in the docket.

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

SUPPLEMENTARY INFORMATION: In the Federal Register of March 6, 2020 (85 
FR 13312), FDA issued a final regulation banning electrical stimulation 
devices (ESDs) for self-injurious behavior (SIB) or aggressive behavior 
(AB). This final regulation provided two operational dates. The ban is 
in effect for all devices as of April 6, 2020, 30 days after the date 
of publication. However, for devices in use on specific individuals as 
of the date of publication and subject to a physician-directed 
transition plan, compliance is required on September 2, 2020, 180 days 
after the date of publication of the final rule.
    FDA received two requests under 21 CFR 10.35 to immediately and 
indefinitely stay these dates for the final regulation banning ESDs for 
SIB or AB. The first petition, dated March 20, 2020, is from Eckert 
Seamans Cherin & Mellot, LLC on behalf of their client, the Judge 
Rotenberg Educational Center, Inc. (JRC) (see Docket No. FDA-2020-P-
1166). As described below, FDA temporarily granted this petition (JRC 
petition) in part on March 27, 2020. The second petition, dated March 
24, 2020, is from Todd & Weld, LLP on behalf of their clients the 
parents and guardians of certain patients at JRC, as well as the 
patients themselves, and the JRC Parents and Friends Association, Inc. 
(see

[[Page 50951]]

Docket No. FDA-2020-P-1181). This petition (Parent petition) was routed 
for review and response after FDA's March 27, 2020, letter granting 
JRC's request for a stay in part. Although filed by different parties, 
the Parent petition requested the same action as the JRC petition and 
did not necessitate a different response or change in the stay FDA 
granted in response to the JRC petition. Both petitions request a stay 
based on all four criteria for a mandatory stay or, alternatively, 
based on being ``in the public interest and in the interest of 
justice'' for a discretionary stay (Sec.  10.35 (21 CFR 10.35(e))). 
Because the petitions request the same action for substantially similar 
reasons, FDA has determined that its March 27, 2020, response to the 
JRC petition is equally applicable to the Parent petition. FDA notes 
that both sets of petitioners filed legal challenges to the ban in the 
U.S. Court of Appeals for the D.C. Circuit, which challenges have now 
been consolidated before that court.
    By a letter dated March 27, 2020, FDA responded to the JRC petition 
granting in part a discretionary temporary stay. As the letter states, 
it is in the public health interest and interest of justice to stay the 
compliance date for devices subject to the ban that are currently in 
use on specific individuals who would need to obtain a physician-
directed transition plan to cease use of such devices. The stay is in 
the public interest and interest of justice because of the ongoing 
national emergency caused by ``severe acute respiratory syndrome 
coronavirus 2'' (SARS-CoV-2) and the disease it causes ``Coronavirus 
Disease 2019 (COVID-19).'' Specifically, the creation or implementation 
of a physician-directed transition plan has the potential to increase 
the risk of transmission or exposure to COVID-19, and it may divert 
healthcare delivery resources from other uses during the pandemic.
    The stay is intended to remain in effect for the duration of the 
public health emergency related to COVID-19 declared by HHS, including 
any renewals made by the Secretary in accordance with section 319(a)(2) 
of the PHS Act (42 U.S.C. 247d(a)(2)). Once the public health emergency 
ends, FDA will substantively respond to the petitions, and issue 
another notification in the Federal Register, if necessary, in 
accordance with Sec.  10.35. If the public health emergency ends while 
the consolidated legal challenge in the D.C. Circuit is still pending, 
the stay will continue in effect until: (1) FDA substantively responds 
to the petitions and (2) if FDA does not grant the petitions, the 
parties have had adequate time and reasonable opportunity to obtain a 
ruling from the D.C. Circuit regarding a stay of FDA's response to the 
petitions.
    FDA's partial stay is limited to those devices currently in use on 
specific individuals who have or would need to obtain a physician-
directed transition plan to cease use of such devices in order to 
comply with the final regulation banning ESDs. For all other devices, 
the ban became effective on, and required compliance by, April 6, 2020.

    Dated: July 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-16595 Filed 8-17-20; 4:15 pm]
BILLING CODE 4164-01-P