Federal Regenerative Medicine Law Reference
FED-001
Federal — Expanded Access
Key Requirements
FDA Expanded Access Program
Regenerative Medicine Impact
21 CFR Part 312, Subpart I; 21 U.S.C. § 360bbb
Compliance Notes
1987 (updated 2009)
Active
FED-002
Federal — Right to Try
Key Requirements
Trickett Wendler Right to Try Act
Regenerative Medicine Impact
P.L. 115-176; 21 U.S.C. § 360bbb-0a
Compliance Notes
May 30, 2018
Active
FED-003
Federal — RMAT
Key Requirements
Regenerative Medicine Advanced Therapy Designation
Regenerative Medicine Impact
21 U.S.C. § 356g; P.L. 114-255 (21st Century Cures Act)
Compliance Notes
December 13, 2016
Active
FED-004
Federal — HCT/P Regulation
Key Requirements
FDA Human Cells Tissues Cellular Products — 21 CFR Part 1271
Regenerative Medicine Impact
21 CFR Part 1271; 21 U.S.C. § 351(a) vs. § 361
Compliance Notes
2001 (enforced 2021)
Active
FED-005
Federal — Anti-Kickback
Key Requirements
Anti-Kickback Statute
Regenerative Medicine Impact
42 U.S.C. § 1320a-7b(b)
Compliance Notes
1972 (amended 2010)
Active
FED-006
Federal — Stark Law
Key Requirements
Physician Self-Referral Law (Stark)
Regenerative Medicine Impact
42 U.S.C. § 1395nn; 42 CFR Parts 411, 424
Compliance Notes
1992 (Phase III 2007)
Active
Key Federal Agencies
FDA (Food & Drug Administration)
Regulates exosome products as biologics or HCT/P
CMS (Centers for Medicare & Medicaid)
Coverage and reimbursement determinations
OIG (Office of Inspector General)
Anti-Kickback Statute and Stark Law enforcement
Monthly Update Schedule
FDA Updates
First Monday of each month
State Legislation
Mid-month review
CMS Guidance
Third week of month
TMB Rules
Last week of month