Joe Rolly posted a fantastic article explaining the pathways by which various CTPs/skin subs come to market, and what that means in terms of the claims that sales representatives can make.
Because amniotic products are the fastest growing sector of the market, I am going to discuss the claims that can be made about them. As Joe explained, if the FDA designates a product to be minimally manipulated human tissue, there is no premarket approval or clearance performed by FDA. Such products are not regulated as medical devices. Therapeutic claims about these products are limited to the same role the harvested tissue originally provided in the body (that is considered “homologous use.”)
The FDA has determined that the role of tissue derived from umbilical cords and placentas (“amniotic” products) is primarily to cover, cushion, and protect the surrounding tissue/fetus. Thus, manufacturers of amniotic products must be careful making claims that the product promotes healing. They can describe how their products have been used by clinicians and on what types of wounds.
If a company promotes a bigger role than just “covering or protecting,” the FDA can reclassify it as a medical device and require that the manufacturer go through submission to the premarket approval or clearance process. The physician who got the above email claiming that an amniotic product “promotes rapid healing” and “reduces infection risk” could report that regulatory misconduct to the FDA.
Dr. Fife is a world renowned wound care physician dedicated to improving patient outcomes through quality driven care. Please visit my blog at CarolineFifeMD.com and my Youtube channel at https://www.youtube.com/c/carolinefifemd/videos
The opinions, comments, and content expressed or implied in my statements are solely my own and do not necessarily reflect the position or views of Intellicure or any of the boards on which I serve.
So tired of the overreach of individuals, everywhere, all the time, and anyway they can, or promoting themselves (‘Dunning-Kruger Effect’) or their products (simple bias). It’s egregious because they know their product doesn’t do what they claim, but our world has become saturated with inflated promises, and promises broken!