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

1 organizations filed 1 public comment on 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, at the Food and Drug Administration. The comment window closed 881d ago.

Abstract

The Food and Drug Administration (FDA) is proposing to classify certain types of wound dressings and washes containing antimicrobials acting as preservatives or protectants within the product and/or other chemicals into three classifications: (1) solid wound dressings; (2) wound dressings formulated as a gel, cream, or ointment; (3) liquid wound washes. FDA is proposing to classify such products containing antimicrobials with high level of antimicrobial resistance (AMR) concern (i.e., medically important antimicrobials) into class III and products containing antimicrobials with medium or low level of AMR concern and/or other chemicals into class II (subject to special controls and 510(k) requirements).

Commenters (1)

• Consumer Healthcare Products Associationtrade assoc.

  1 filing · confidence 97%