Regulations.gov document

Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Devices…

Rule · FDA-2014-N-1209 · posted Dec 20, 2019

Key facts

Document ID FDA-2014-N-1209-0315
Title Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Devices Intended To Treat Anxiety and/ or Insomnia; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Devices Intended To Treat Depression
Document type Rule
Subtype Final Rule
Agency FDA
Docket FDA-2014-N-1209
Posted Dec 20, 2019
Federal Register citation 84 FR 70003
FR document number 2019-27295
CFR 21 CFR Part 882
Comment period opens Dec 20, 2019
Effective date Dec 20, 2019

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