Medical Devices; Petition for an Administrative Stay of Action: Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior
fda-device · Food and Drug Administration · Rule · Published 2020-08-19 · 85 FR 50950
Document
Document number
2020-16595
Federal Register citation
85 FR 50950
CFR reference
21 CFR 882
Type
Rule
Action
Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2020-08-19
HHS docket
Docket No. FDA-2016-N-1111
Abstract
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.