By: Matthew Fischer
Certain stem cell products fall under the definition of a HCT/P. If so, unless an exception is met, the product will be subject to regulation by various laws and regulations such as the Food, Drug and Cosmetic Act (“FDCA”), Public Health Safety Act (“PHSA”), and 21 CFR 1271. When determining which apply, 21 CFR 1271.10(a) and the exception in 21 CFR 1271.15(b) (i.e. the “Same Surgical Procedure Exception”) must be reviewed. However, many are left asking: what is the relationship between the same surgical procedure exception and the four criteria set forth in 21 CFR 1271.10(a)? Thanks to recent guidance released by the FDA, some clarification has arrived.
In a general sense, the regulations found in 21 CFR 1271.15, including 21 CFR 1271.15(b), provide the exceptions from requirements such as premarket review. In contrast, the four criteria set forth in 21 CFR 1271.10(a) are reviewed to assess whether the product, if an exception does not apply, is regulated solely under parts of the PHSA and Part 1271. In its recent guidance, the FDA indicated that the assessment of whether an exception applies is independent from the determination of whether the criteria of 21 CFR 1271.10(a) are met (e.g. minimal manipulation, homologous use). In other words, 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). Therefore, if a product meets an exception then the determination of whether the four criteria in 21 CFR 1271.10(a) are met is moot which means the analysis ends there.
With the publication of this guidance, the FDA’s commissioner released a statement announcing that “[the FDA is] adopting a risk-based and science-based approach that builds upon existing regulations to support innovative product development while clarifying the FDA’s authorities and enforcement priorities.” Given this position and the issuance of new framework, affected healthcare businesses should continue to stay informed as the FDA intends to balance the interests of protecting patients on one hand and accelerating access to effective new treatments on the other.