FDA HCT/P Guidelines: Understanding and Adherence

Published by Nicolas Tierney

June 27, 2019

Summary

Government regulators, providers, payers and patients increasingly recognize the potential benefits of human cell and tissue products (“HCT/P”). At the same time, they are differentiating between “good actors” and “bad actors” in the clinical delivery of those HCT/P’s. The recent U.S. federal court injunction against US Stem Cell Centers confirms the FDA’s commitment to enforcing its HCT/P regulations against clinicians it places in the latter category. That case makes clear, for example, that enzymatic digestion of adipose – commonly used to produce stromal vascular fraction – is considered more than minimal manipulation and thus subject to regulation as a drug.

The FDA HCT/P regulations in this broad field involve three foundational concepts: autologous source, minimal manipulation and homologous use. To help clinicians understand and document compliance with them, inCytes™ now includes a short survey/report addressing key elements surrounding harvest, processing and delivery of a large number of applicable cell/tissue types. The survey and report – easily modifiable for specific practice considerations – will inform regulatorily-compliant clinical protocols, support patient engagement, establish correlations with outcomes, and document protocol and regulatory compliance.

Surveys and reports, all easily customized, are available on inCytes™ for many indications, procedures and patient cohorts. New ones are created regularly, often for the specific needs of Users.  Sign up for a free, custom trial today of the platform designed by clinicians for clinicians to capture and exploit true clinical evidence.

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