The U.S. Food and Drug Administration (FDA) is proposing to classify certain unclassified, wound dressings and liquid wound washes containing antimicrobials or other chemicals into three separate classification regulations:

• solid wound dressings
• wound dressings formulated as a gel, cream, or ointment; and
• liquid wound washes.

The proposed classification for these wound dressings and liquid wound washes is intended to be split into two classifications:

• For class II, the FDA is proposing these devices be subject to special controls and premarket notification requirements, in addition to general controls. The FDA is proposing that manufacturers will need to demonstrate compliance with applicable special controls within six months after the effective date of the rule, when finalized.
• For class III, the FDA is proposing to require that manufacturers file a premarket approval application (PMA) in accordance with the timeframe as discussed in the accompanying proposed order.