Important Factors in Regulatory Compliance for Regenerative Medicine Products

Two Important Factors for Complying With Regenerative Medicine Regulations

Donor Eligibility

Determining whether a donor is eligible or ineligible to donate cells or tissues for use in therapies.

• Based on donor screening and testing for communicable disease
• Requires thorough documentation
• Must screen for the list of diseases specified by FDA
• Donor eligibility is not required for autologous use

Good Tissue Practices

Emphasis on avoiding cross contamination and spread of communicable disease.

• Tracing of tissue from donor to recipient
• Distinct identification code for each donor to protect anonymity
• Methods to communicate potentially contaminated tissue to suppliers and recipients
• Ensure handling of HCT/P’s without mix-ups or cross contamination