Regulatory Open Forum

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  • 1.  FRO Product Code

    Posted 26-Apr-2018 17:44

    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.


  • 2.  RE: FRO Product Code

    Posted 27-Apr-2018 04:25

    Potentially that Product Code could be used.  Unfortunately Product Code FRO is one of those "bucket" product codes where many different types of products have been put into this product code.  It can take a long time to go through all the product clearances and 510(k) Summary to see if there is a potential predicate device.  I would suggest conducting a regulatory strategy review to determine 1) product claims, 2) indication for use, and most importantly 3) identification of a predicate device.  The FDA 510(k) process could only be used if you can identify a proper equivalent predicate device.  There are a couple product codes for hold/cold packs/compress that might also be used.  But if you are including in the indications for use wound management, then it might be proper under FRO.  You are correct that adding antimicrobial will push it into a combination product.

    Richard Vincins RAC
    Vice President Regulatory Affairs

  • 3.  RE: FRO Product Code

    Posted 03-May-2018 12:46
    Thank you all.  You guys are always so amazing and your feedback is always so well presented and explained.  I thank you all again.  This has been a challenging new environment for me and I could not have possibly done it without the help and guidance from you all.

    Thanks and I will look through all the resources thoroughly.

    Thank you,

    Laura HoShue
    Regulatory Compliance Specialist
    Las Vegas, Nevada

  • 4.  RE: FRO Product Code

    Posted 27-Apr-2018 07:58

    You may find this link of interest if considering FRO: 

    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.

    D Michelle Williams
    United States

  • 5.  RE: FRO Product Code

    Posted 27-Apr-2018 09:18
    General note that a year ago (or two) the FDA had a discussion about breaking the FRO product code into three separate codes and classifying them.  I recall they wanted to differentiate between physical dressings (bandages) & creams & ointments but spoke little of sterile saline and water.

    As we know this change may never occur or take years

    Valerie Followell
    Skokie IL
    United States

  • 6.  RE: FRO Product Code

    Posted 28-Apr-2018 08:30
    You can try a pre sub or 513(g) approach.  Save time and money and not guess.

    All the best,


    Robert Schiff, PhD, RAC, CQA, FRAPS
    President and CEO
    Schiff & Company, Inc.
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  • 7.  RE: FRO Product Code

    Posted 27-Apr-2018 14:37
    This is the sort of issue that might be best addressed with a pre-sub meeting, to get FDA to buy into your regulatory strategy. Might minimize long struggles during the 510(k) process.

    Corey Jaseph RAC
    Director of Regulatory Affairs
    South Jordan UT
    United States

  • 8.  RE: FRO Product Code

    Posted 29-Apr-2018 10:37
    Agree with what couple other have said; if you are unsure of the classification, the best method to use is the 513(g) Request for Classification that you can propose to FDA the Product Code, Class, predicate device, and plan to utilise 510(k) process, and then see if they agree.

    Richard Vincins RAC
    Vice President Regulatory Affairs

  • 9.  RE: FRO Product Code

    Posted 01-May-2018 20:29
      |   view attached
    Hi Laura,

    You may have seen this already, but if not, it may be of some help for you. Attached is an FDA presentation on wound dressings, (FRO).

    Jon Cook
    San Jose CA
    United States