In the previous post: Same Surgical Procedure Exception Guidance: What Does “Such HCT/P” Really Mean? Part One, I started exploring what I think the FDA is trying to tell us stakeholders in its recently issued Guidance entitled, “Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception”. I already have covered some of the background for this Guidance, including how the FDA needed to provide a way for physicians who had been working routinely with HCT/Ps for decades not to have to register with the FDA as manufacturers of those HCT/Ps, so they included 1271.15(b) as a kind of physician safety valve.
I also covered the critical concept of “such HCT/P”, which the FDA is using to restrict what can and can’t be done with a patient’s tissues. In order to reduce ambiguity for the benefit of healthcare providers, the FDA quite definitively stated that enzymatic digestion or mechanical disruption of adipose tissue results in the HCT/P failing to meet the “such HCT/P” requirement. For example, a physician making SVF (the cellular preparation obtained from adipose tissue) is required to register with the FDA—which is a big deal, because SVF is not an HCT/P that is “original”. Furthermore, the determination that SVF doesn’t meet the “such HCT/P” requirement in 1271.15(b) isn’t based on the minimal manipulation standard established in 1271.10(a)(1), but on the processing language the FDA associates specifically with 1271.15(b). This will pose a problem for physicians trying to circumvent regulations for working with a patient’s adipose tissue at point-of-care (POC).
Much of what appears in the final version of the Same Surgical Procedure Exception Guidance just issued on November 16, 2017, was also present in the draft version the FDA issued back in October 2014. However, there is a new wrinkle in the final Guidance which is completely absent from the draft Guidance. The newly revealed aspect concerns the sequence of steps physicians are supposed to follow to determine if what they are doing allows them to invoke the exception. The FDA doesn’t regulate a physician’s practice of medicine, but when the physician is engaged in making HCT/Ps as defined by the FDA, the physician is a manufacturer and consequently is regulated by the Agency.
The relevant text from the Guidance covering the new wrinkle is as follows (with edits):
“…the assessment of whether the exception in 21 CFR 1271.15(b) applies is made before considering the four criteria in 21 CFR 1271.10(a). Thus, if an establishment meets the exception in 21 CFR 1271.15(b), the establishment is excepted from the requirements under Part 1271 and the establishment need not consider whether that HCT/P meets the four criteria in 21 CFR 1271.10(a).”
It would seem that physicians (and their establishments) are directed by the FDA to contemplate the handling of the HCT/P, determine if their HCT/P meets the “such HCT/P” requirement, and if it does, they can “pass Go” and treat their patients without a second thought and without registering with the FDA.
Sounds simple, right? However, the FDA has restricted what a physician can and can’t do to a hunk of patient tissue for use at POC and avoid registering with the FDA. In the words of the FDA, processing of HCT/Ps is restricted to “…rinsing, cleansing, sizing or shaping…” for the purposes of meeting the “such HCT/P” requirement. Thus, tissue handling is kept to a bare minimum in order to not cross the “such HCT/P” line.
I was puzzled by the sudden appearance of this advice from the FDA on how physicians should consider the sections of 1271. After all, there was no hint of this approach in the draft Guidance issued three years ago. So, what gives? I think one possible answer lies in the way the SVFing crowd of healthcare providers seized on 1271.15(b) as a kind of sanctuary available to white lab coat-wearing physicians who thought they could escape the Agency’s wrath while ignoring the obvious regulations against extracting SVF from adipose tissue and treating patients with it.
In particular, an attorney previously wrote a blog post on how to distort 1271.15(b). for fun and profit by SVFing physicians and networks (See previous post: Catching Up on Regulatory Affairs – Part One). He indicated that since the words “homologous use” and “minimal manipulation” didn’t appear directly in the language of 1271.15(b), those criteria weren’t relevant for a physician in determining if the physician was able to invoke the exception. Needless to say, the SVFing crowd embraced this dubious legal ploy with open arms, resulting in the subsequent regenerative medical free-for-all that has been going on for several years.
Not anymore. By directing physicians to start with the elements listed in 1271.15(b), the FDA neatly side steps the issue raised by the attorney and eliminates the sanctuary used by so many SVFing physicians and clinics as they have flagrantly violated the regulations in 1271. In other words, a physician can’t do much with adipose tissue obtained from a patient other than wash it, concentrate it and then return it to the patient as a fat graft for placing in subcutaneous tissue depots. So, no more free-lancing and treating patients with a little SVF for whatever ails them.
Although it is obvious to me, and by now I should think to all of the active SVFing physicians and clinics who process a patient’s adipose tissue to extract cells remains non-compliant, in the next post I will focus on all of the ways the FDA drives that point home throughout the newly issued Guidances.