Regulatory Intelligence & Compliance Resource Center
This resource center serves as a structured regulatory reference hub for licensed healthcare professionals and institutional operators evaluating biologic product categories within the framework of 21 CFR Part 1271.
Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) may be regulated under Section 361 or Section 351 of the Public Health Service Act depending on classification criteria including minimal manipulation, homologous use, systemic effect, and manufacturing controls.
The materials below provide neutral regulatory analysis, governance clarification, enforcement context, and compliance literacy resources to support structured institutional review.
Core 21 CFR 1271 Regulatory Framework
Qualification under Section 361 requires satisfaction of criteria defined in 21 CFR 1271.10(a), including minimal manipulation, homologous use, non-combination status, and limited systemic effect.
Regulatory classification pathways and compliance implications.
Structural vs cellular standards and FDA interpretation trends.
Intended use analysis and “same basic function” criteria.
Manufacturing safeguards and Subpart D compliance requirements.
Registration, donor eligibility, and compliance structure overview.
Public warning letters, enforcement patterns, and compliance risk considerations.
State legislative developments may introduce additional disclosure or procedural requirements. Federal regulatory obligations remain independently applicable.
Governance & Institutional Safeguards
Operational boundaries and documentation discipline framework.
Eligibility determination, infectious disease testing, and traceability safeguards.
Conservative positioning standards and regulatory language discipline.
Supplier-reported sourcing integrity and donor screening overview.
Informational overview of Florida statutory provisions and interaction with federal HCT/P regulatory requirements.
Scientific & Literature Context
Neutral scientific publications relevant to extracellular matrix and vesicle biology.
Educational summary of limited observational and early-stage research.
Frequently Asked Regulatory Questions
What is 21 CFR Part 1271?
21 CFR Part 1271 establishes FDA requirements for HCT/Ps including registration, donor eligibility determination, and manufacturing safeguards.
What determines whether a product qualifies under Section 361?
Qualification requires meeting all criteria under 21 CFR 1271.10(a), including minimal manipulation, homologous use, non-combination status, and limited systemic effect.
See: Section 361 vs Section 351 | Minimal Manipulation | Homologous Use
Does registration under 21 CFR 1271 mean FDA approval?
No. Establishment registration does not constitute FDA approval, clearance, or evaluation of safety or effectiveness.
What is minimal manipulation?
Minimal manipulation refers to processing that does not alter the original relevant characteristics of structural tissue or biological characteristics of cells or nonstructural tissue.
What is homologous use?
Homologous use means the product performs the same basic function in the recipient as in the donor.