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


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A Comparative Framework Between New Product and Legacy Product Process Validation

This paper is a comparative analysis between the application of the FDA Process Validation Guidance (2011) to new products and legacy products.