FDA has determined that these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling. The Food and Drug Administration (FDA, the Agency, or we) is finalizing a ban on electrical stimulation devices (ESDs) for self-injurious or aggressive behavior. Start Preamble Start Printed 12 AGENCY:įood and Drug Administration, HHS. Labeling and Correcting or Eliminating Risks State of the Art for the Treatment of SIB and AB Background Information About ESDs, SIB, and AB Comments on the Proposed Rule and FDA's Responses FDA's Determination That ESDs for SIB or AB Present an Unreasonable and Substantial Risk of Illness or Injury Public Participation, Clarifications, and Key Changes
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