Laura,
You may find this link of interest if considering FRO:
https://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/medicaldevices/medicaldevicesadvisorycommittee/generalandplasticsurgerydevicespanel/ucm521003.pdfhttps://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/medicaldevices/medicaldevicesadvisorycommittee/generalandplasticsurgerydevicespanel/ucm521003.pdf Based on my knowledge and what I have found a cold compress is not a would dressing. Here is a definition from the FDA website:
Solid wound dressings have been cleared, for example to provide or support a moist wound environment, absorb wound exudate, and protect against external contamination. These dressings are typically cleared for use on a variety of wounds, including traumatic wounds, partial thickness burns, ulcers (e.g., venous stasis ulcers, diabetic foot ulcers, arterial ulcers), or surgical wounds. These wounds may or may not be colonized with microbes or be infected. Some dressings are cleared for use to cover and protect catheter insertion sites or other percutaneous device insertion sites (e.g., drains, orthopedic external pins). Some are cleared for management of infected wounds . Some are cleared to provide an antimicrobial "barrier to bacterial penetration of the dressing as this may help reduce infection" or for the "control of wound bacteria within [the dressing that] may help reduce the risk of wound infection".
Hopefully this helps.
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D Michelle Williams
United States
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Original Message:
Sent: 26-Apr-2018 17:43
From: LAURA HOSHUE
Subject: FRO Product Code
Team,
I recently came across some discussion on the FRO product code and I am wondering if our proposed device would be considered this type of device/product. What I would like to understand is what types of products would be considered "wound dressing". I have yet to find a device or product with the following intended use, and wonder if in fact it would fall under the FRO umbrella:
A cold compress to closed soft tissue injury, skin cold care after laser cosmetic surgery, postoperative burn surgery, small area facial surgery, sunburn dermatitis, hormone-dependent dermatitis, acne, skin sensitivity, etc. It is to be used for cold compress on the body and can relieve discomforts such as fever, tiredness, body aches, etc.
To date it is undecided as to whether the product will have an antimicrobial which would make it a combination product (device + drug). Can anyone shed more light on their experience with the FRO product category? The product will be in both patch and spray form.
Thanks,
Laura