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FDA Set to Reclassify Several Wound Dressings to Class III Medical Devices
(Thursday, November 30, 2023) A new proposed rule intends to reclassify several wound dressings from 510k to Class III PMA medical devices based on the use of certain types of antimicrobials in these products. FDA will also create new product codes for several wound dressings that are currently designated as pre-amendment unclassified medical devices. Many of these wound dressings have been available to the patients since prior to May 1976 when the medical device regulations were implemented. This will increase the regulatory burden for market approval of these products. The main purpose of the rule is to regulate wound dressings that contain antimicrobials that may pose a high risk of developing antimicrobial resistance (AMR). Specifically, wound dressing containing polymyxin B, silver sulfadiazine, and bacitracin would be reclassified as Class III devices and require PMA as these are known to have high risk of AMR. Wound dressings containing other antimicrobials such as silver, zinc, copper, chlorhexidine, benzalkonium chloride, parabens, hypochlorous acid, peroxide, polyhexamethylene biguanide, and iodine will remain Class II medical devices with new product codes. They would continue to be cleared through the 510k pathway. The rule contains detailed descriptions of various kinds of wound dressings that could be a great educational resource for developers of wound dressings in general and those with antimicrobials specifically. A wound dressing could be solid, gel/ointment, or a liquid. Wound care products are either used as a barrier (such as solid dressing), moisture control (such as gels and ointments), or cleaners (such as liquid wound washes). In all cases, they would be classified as medical devices and not as combination products or drugs even if they contain drug ingredients. Other chemicals added to wound dressing will not affect their device classification. The rule has been a long time in the making with the original recommendations to reclassify from 1998 and the last one from 2016. The text of the proposed rule provides an excellent primer on various kinds of wound dressings and their potential applications. The rule is applicable to only wound dressings used for external wounds and does not apply to those not containing antimicrobials. The rule is not retrospectively effective so the wound dressing already in the market under the previous 510k category would stay. New products will, however, need a PMA instead of 510k if they contain the high-risk AMR antimicrobials. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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