The USA Standard
All donors and all units have been selected and screened according to Cryos International’s extensive quality assurance, operational procedures and policies for donor recruitment, assessment and screening. All units which meet the USA Standard also meet the specific FDA requirements in force at the time of donation, regarding screening, quarantine, age and anonymity.
The list below represents, to our knowledge, an overview of current, relevant regulation:
- Title 21-PART 1271 HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
- Guidance for Industry - Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)