WOCN Comments on FDA Proposed Rule for Wound Dressings

In February, WOCN commented (attached) in response to a proposed rule from the U.S. Food & Drug Administration seeking 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.

The FDA is proposing to change the regulatory status for hundreds of commonly used wound products which could significantly impact the availability of those products on the marketplace and harm patient care. WOCN asked that FDA reconsider this proposed rule and work with clinicians to ensure patient care is not disrupted while the Agency reconsiders the classification of these wound dressings, creams, gels, and washes. This proposed rule is still pending.