TBT BSN | Notification

Notification Detail :: G/TBT/N/USA/2108

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

Banned Devices; Proposal To Ban Electrical Stimulation Devices 
for Self-Injurious or Aggressive Behavior

Objective

Prevention of deceptive practices and consumer protection (TBT); Protection of human health or safety (TBT)

Product Covered

Electrical stimulation devices intended for self-injurious behavior; Medical equipment (ICS code(s): 11.040); Domestic safety (ICS code(s): 13.120)

Document Notification

Link to ePing

HSCODE

ICSCODE

11.040 - Medical equipment; 13.120 - Domestic safety

Keywords

Human health

Specific Regions

Description

Proposed rule - The Food and Drug Administration (FDA, the Agency, or we) is 
proposing to ban electrical stimulation devices (ESDs) intended for 
self-injurious behavior (SIB) or aggressive behavior (AB). FDA has 
determined these devices present an unreasonable and substantial risk 
of illness or injury that cannot be corrected or eliminated by 
labeling. This proposal follows a court decision vacating a prior ban 
and amendment to the Federal Food, Drug, and Cosmetic Act clarifying 
our authority to ban a device for one or more intended uses. This 
action, if finalized, will mean ESDs for SIB and AB are adulterated and 
not legally marketed.

Notified Document

1:File here

Link to Notification

EN:File here

FR:File here

ES:File here

Status Active

No	#	Comment By	Title	Comment Date	File

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Notification Detail :: G/TBT/N/USA/2108

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