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 6 March 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 6 March 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.
Actions notified under the symbol G/TBT/N/USA/1113 are identified by Docket Number FDA-2016-N-1111. The Docket Folder is available on Regulations.gov at https://www.regulations.gov/docket?D=FDA-2016-N-1111, and provides access to primary and supporting documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Number.