We are not a law firm, but we build IT systems that support your compliance obligations. The FDA regulates HCT/Ps under 21 CFR Part 1271, separating products regulated solely under Section 361 of the Public Health Service Act from 351 biologics that require FDA approval. Since the enforcement discretion period ended in May 2021, thorough and defensible documentation has become more important than ever. We make sure your consent forms, treatment records, and imaging are stored securely, backed up, and retrievable. That gives your clinical and legal teams the reliable records they need.