Regulatory

Regulating Bodies

Under the Department of Health and Human Services (HHS)


The Organ Procurement and Transplantation Network (OPTN) is contracted under the United Network for Organ Sharing (UNOS),a private non-profit organization which operates under federal oversight. The OPTN forms policy and collects data based on objective and quantifiable medical statistics. To view the current OPTN Policies, click here.

OPOs are neither classified as providers nor suppliers. They fall under the Centers for Medicare and Medicaid Services’s Center for Medicaid, CHIP and Survey & Certification. This office supervises the planning, coordination and implementation of OPO surveys. Surveys are required for recertification. The Center for Medicaid, CHIP and Survey & Certification also investigates claims and conducts enforcement programs for all Medicare and Medicaid providers and suppliers. As federally mandated non-profit organizations, OPOs are required to submit cost reports to CMS.

The Health Resources and Services Administration (HRSA) regulates solid organ transplantation and vascularized organs used for transplantation.

Under 21 CFR Part 1271, the FDA is responsible for developing screening and testing protocols for human cells, tissues and cellular and tissue-based products (HCT/Ps). Examples include skin, and musculoskeletal, cardiovascular and ocular tissues. Although the FDA does not regulate solid organ transplantation, they are involved through shared donors. The FDA also regulates infectious disease testing. The CDC does not have regulatory authority, but OPOs are required to report any cases of potential transmission to UNOS. The CDC can investigate those cases.