FDA Certfication Form
Beginning May 25, 2005 all laboratories that collect, freeze and store human reproductive tissues are required to comply with FDA rules. These regulations are specified in 21 CFR (code of Federal Regulations) part 1271. The regulations consist of three parts: Registrations Final Rule, Donor Eligibility Final Rule, Current Good Tissue Practices Final Rule.
The two rules that apply to reproductive tissue banks are:
The Registration Final Rule
The Donor Eligibility Final Rule
(These rules are designed to ensure the safety of transplanted human cells and tissues.)
International Cryogenics has always maintained the highest standards in the testing and screening of our donors and is continuing to implement these standards in compliance with the new FDA regulations. International Cryogenics has been registered with the FDA since 2001.(see forms link below to get .pdf copy of FDA) Donor specimens processed prior to May 25, 2005 are not subject to the new FDA rules. Specimens that were shipped to physicians prior to May 25, 2005 are not required to have the updated documentation required by the new FDA regulations. All specimens shipped after May 25, 2005 will include a summary of records including all sexually transmitted disease testing performed on the donor and an interpretation of those records.
- FDA registered (FEI: 3004561638)
ICI FDA Certification (PDF)
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If you are having trouble downloading or reading this document please call, (248) 397-8449.