Regulations.gov document

Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To…

Proposed Rule · FDA-2014-N-1209 · posted Jan 22, 2016

Key facts

Document ID FDA-2014-N-1209-0001
Title Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression
Document type Proposed Rule
Subtype Notice of Proposed Rulemaking (NPRM)
Agency FDA
Docket FDA-2014-N-1209
Posted Jan 22, 2016
Federal Register citation 81 FR 3751
FR document number 2016-01173
CFR 21 CFR Part 882
Comment period opens Jan 22, 2016
Comments due Apr 22, 2016
Effective date Jan 22, 2016

At a glance

  • 10–99 Pages
  • No Open for comment
  • 100–999 Public comments on this docket

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