TBT BSN | Notification

Notification Detail :: G/TBT/N/USA/2071

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

Medical Devices; General and Plastic Surgery Devices; 
Classification of Certain Solid Wound Dressings; Wound Dressings 
Formulated as a Gel, Creams, or Ointment; and Liquid Wound Washes

Objective

Protection of human health or safety (TBT)

Product Covered

Wound dressings and liquid wound washes containing antimicrobials and/or other chemicals as solid wound dressings; wound dressings formulated as a gel, cream, or ointment; and liquid wound washes; Medical equipment (ICS code(s): 11.040); Wound dressings and compresses (ICS code(s): 11.120.20); First aid (ICS code(s): 11.160)

Document Notification

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HSCODE

ICSCODE

11.040 - Medical equipment; 11.120.20 - Wound dressings and compresses; 11.160 - First aid

Keywords

Human health

Specific Regions

Description

Proposed rule - The Food and Drug Administration (FDA, Agency, or we) are 
proposing to classify certain types of wound dressings and liquid wound 
washes containing antimicrobials and/or other chemicals (unclassified, 
preamendments devices) as solid wound dressings; wound dressings 
formulated as a gel, cream, or ointment; and liquid wound washes. FDA 
currently regulates these unclassified devices as devices requiring 
premarket notification (510(k) requirements), with the product codes 
FRO, GER, MGP, MGQ, and EFQ, but FDA intends to create new product 
codes for these proposed classifications upon finalization of this 
classification action. FDA is proposing to classify certain wound 
dressings and liquid wound washes containing antimicrobials with a high 
level of antimicrobial resistance (AMR) concern (i.e., medically 
important antimicrobials) into class III. In addition, FDA is proposing 
to classify certain wound dressings and liquid wound washes containing 
antimicrobials with a medium or low level of AMR concern and/or other 
chemicals, into class II (subject to special controls and 510(k) 
requirements).

Notified Document

1:File here

Link to Notification

EN:File here

Status Active

No	#	Comment By	Title	Comment Date	File

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Notification Detail :: G/TBT/N/USA/2071

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