William Storage Hmm. So much for the long-held distinction that drugs involve chemical action or metabolizing by the body and devices do not. Antimicrobials would not seem to meet that criterion.

In this case, the antimicrobial supposedly acting within the dressing to prevent contamination of the dressing rather than in the wound; thus, the mode of action is mechanical. It gets tricky because at what point does the an antimicrobial in the dressing also act within the wound.

William Storage Right. And even acting on the wound would not involve the metabolism of the patient.

Sorry for the detour; but as a supplier of materials / substrates for the dressings & backing, I wonder how this reclassification might effect regulation around those materials? I guess time will tell ...

Julie Omohundro As I understand it, FDA isn't considering reclassifying wound dressings AS drugs, but reclassifying dressings that contain drugs as Class I, II, or III devices, depending on whether they contain wound irrigation solutions, antimicrobials, or antibiotics.

Julie, you are correct. In general, the committee recommended to FDA that devices containing:
True antibiotic agents, such as gentamycin, be classified into Class III;
Dressing, oils, creams and gels containing general antimicrobials as Class II with special controls; and
Wound irrigation solutions as Class I.

Jean Bigoney, RAC, CQE I think I'm confused. At least the FRO products I have been involved with have always been classified according to this scheme. Wound dressings with antimicrobial agents are also specifically listed as combination products with CDRH jurisdiction here:
http://www.fda.gov/CombinationProducts/JurisdictionalInformation/ucm121177.htm
Does this mean that FDA is going to search through all wound dressings cleared as FRO before a certain date and change the classification?

Samantha Pree-Stinson,PMP-C I get it. It is not the medication itself but the mechanism of which it is delivered. But that is ridiculous. Band-Aid makes these OTC you can buy. Sure the medication on it is not presciptive but the. Band-Aid itself would still be considered a delivery system. Of course the public needs to be kept safe but we need balance. The FDA can be so involved at times that it feels like they are running the companies.

Steven, while you will not be directly impacted, your company could potentially be affected by the data your customers may require for your materials or components as a result of the special controls and performance data requirements that may result from reclassification. FDA will likely issue new or finalize existing guidance documents (see http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071380.htm). Customers will likely be looking to suppliers for additional data and testing to support their claims. As you know, it always rolls downhill....

Hi jean. The products have always been "unclassified" but required a 510k (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=5587) so the marketing pathway is functionally similar to a class II device. If FDA adopts the panel's recommendation, some will be class III requiring PMA's, most class II but subject to special controls that do not yet exist, and some will be down classified to class I and not require a premarket submission. It is to be determined if FDA is going to implement the regulations going forward and let cleared products be or if they are going to issue a call for manufacturers to send in new submissions demonstrating compliance with new controls. FDA will likely require new submissions and safety data for the products it reclassifies as Class III.

TOMMORROW OCT 20 IS THE DAY! Be sure to submit your opinions to FDA for your voice to be heard in this pivotal rule making!

Julie Omohundro Samantha, it is the medication that FDA would use for classification, because the type of medication tends to reflect the seriousness of the wound. It is the wound dressing that puts these products under CDRH instead of CDER, because the dressing, not the medication, is considered the primary means by which they accomplish their intended use. It is the two together that make these combination products.

Band-Aids are used to expedite healing of minor wounds that would heal eventually anyway. If a Band-Aid fails, that's no big deal...low risk (Class I).

Wound dressings are used on wounds like this:
http://www.mebostore.com/image/data/MEBO+Wound+&+Ulcer+Dressing.files/image001.jpg
Infections associated with these wounds can lead to amputation and death.. If a dressing that is used to treat these wounds fails, that's a very big deal...high risk (Class III).

Julie Omohundro Jean, I'm not sure exactly what process they are proposing to follow. Michelle's article includes a link to the meeting materials for the advisory panel that deliberated the matter at length in September.

Jean Bigoney, RAC, CQE Thanks Michelle. I've done FRO wound dressing 510(k)s and I'm not clear on what is changing going forward. The Class I irrigation types were not exempt by the way - they have been Class I reserved requiring a 510(k). Why don't they assign new procodes instead of having Class I, II and III in FRO I wonder?