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21 CFR 1271.10(a) defines whether an HCT/P may be regulated under Section 361 Criteria to be met Minimal manipulation Homologous use Not combined w/ exceptions No systemic/metabolic dependence w/ exceptions Classification determines regulatory pathway #HCTP #FDA #Regulatory

This Memorial Day we recognize discipline responsibility and sacrifice In biologics those same principles matter protecting patients through standards 21 CFR Responsibility is not optional it’s foundational #MemorialDay #21CFR1271 #HealthcareCompliance #Biologics #HCTP

Full explanation: notbychance.life/homologous-use…

Homologous use is a core regulatory criterion under 21 CFR Part 1271. It determines whether a tissue performs the same basic function in the recipient as in the donor — a key factor in Section 361 classification. Educational breakdown below.

Minimal manipulation is a core regulatory criterion under 21 CFR Part 1271. It determines whether processing alters the original characteristics of a tissue — a key factor in Section 361 classification. Educational breakdown below.

Additional overview here: notbychance.life/21-cfr-1271-re…

Section 361 vs Section 351 what clinics should actually be reviewing This overview highlights: • Minimal manipulation • Homologous use • Regulatory classification differences Designed for internal review and documentation clarity. #21CFR1271 #HCTP #MedicalCompliance

Homologous use under 21 CFR Part 1271: Same basic function in donor and recipient. That’s the standard the FDA uses to evaluate classification Function — not source — determines pathway. notbychance.life/homologous-use…

@anxietymsgs We already do

Homologous use = same basic function Under 21 CFR Part 1271 classification depends whether a tissue performs the same role in the recipient as in the donor Function determines regulatory pathway not source Learn more notbychance.life/homologous-use… Educational only Not FDA evaluated

Section 361 vs Section 351: Not all tissue-based products are regulated the same way Classification under 21 CFR Part 1271 depends on: • Processing • Intended function • Regulatory criteria Not naming Learn more: notbychance.life/section-361-vs… Educational only. Not FDA evaluated

Chain of custody is a critical part of traceability under 21 CFR Part 1271 Donor recovery to clinical documentation each step must be documented maintaining traceability notbychance.life/tissue-chain-o… Educational only Not evaluated by FDA #HCTP #21CFR1271 #cGTP #BiologicCompliance

Minimal manipulation (21 CFR 1271.3(f)) is central to HCT/P evaluation. This infographic outlines how tissue characteristics and processing are assessed within the Section 361 framework. notbychance.life #HCTP #FDA1271 #RegulatoryScience

Quick key takeaway for licensed providers: When sourcing perinatal-derived biologics, always verify Section 361 HCT/P alignment through full chain of custody and third-party CoA with post-thaw specs. What’s your biggest question on EXM vs. EXO/EXS classifications? Drop it below

Biologic product education: categories (EXM, EXO, EXS), U.S. sourcing standards, and 21 CFR Part 1271 overview for licensed providers. Educational only. notbychance.life #HCTP #FDA1271

Tissue chain of custody matters. From donor recovery to clinical use, each step requires documentation and traceability under 21 CFR Part 1271. Educational overview: notbychance.life

@FDA_Drug_Info @NIH Additional regulatory education resources available at notbychance.life

Understanding the regulatory framework behind biologic materials is essential. This infographic explains how 21 CFR Part 1271 governs HCT/Ps. Which concept is most misunderstood: minimal manipulation or homologous use?

Educational resource explaining the HCT/P regulatory framework: notbychance.life/21-cfr-1271-fr… Educational information only. Not intended to diagnose, treat, cure, or prevent any disease.

Understanding the science and regulatory framework behind biologic materials is important for clinicians and researchers. This graphic highlight extracellular matrix biology, extracellular vesicle research and 21 CFR Part 1271. #Biologics #MedicalEducation #HealthcareCompliance