FDA Policies and Information
Cryogenic Laboratories, Inc. Fully Compliant with FDA Regulations
Food and Drug Administration (FDA) requirements for the donation of human cells, tissues, and cellular and tissue-based products (HCT/P's) as specified in 21 CFR (Code of Federal Regulations) Part 1271, went into effect on May 25, 2005. These regulations cover operations engaged in the collection, processing, storage and distribution of human gametes and/or embryos. Specifically, the FDA has established standards for sperm donor eligibility and the testing and screening of donors for relevant infectious diseases.
Cryogenic Laboratories, Inc. has taken all steps necessary to comply with 21 CFR Part 1271. We continue to exceed donor eligibility, genetic and infectious disease testing standards now prescribed by the FDA, and remain dedicated to maintaining our leadership position in sperm quality, donor testing, and patient services.
Some of the key changes resulting from compliance with 21 CFR Part 1271:
1. Registration with the FDA
Cryogenic Laboratories Inc. has been registered with the FDA since January
2004. Our FDA Establishment Identifier (FEI) is 3000243835. A public
query for all Human Cell and Tissue Establishment Registrations (HCTERs)
is maintained by the FDA and may be accessed at: https://www.accessdata.fda.gov/scripts/cber/CFAppsPub/tiss/index.cfm.
The HCTERs site provides a comprehensive detailing of establishment name,
location, registration status, functions, and types of cells and tissues
handled.
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2. Records to Accompany Semen Shipments
Appropriate records will accompany each semen vial that is shipped from
Cryogenic Laboratories, Inc. These records will state the eligibility status
of the donor being released based on the FDA’s eligibility standards.
In addition a summary of records will also be included, listing tests performed
and test results for that donor. Notwithstanding the FDA’s requirements,
be assured that our Medical Director, who has always conducted a donor eligibility
review prior to the release of any semen, will continue this practice. |
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3. Donor Screening and Testing
Donor screening and testing will be completed as required by the FDA in
21 CFR Part 1271 (specifically 1271.75, 1271.80 and 1271.85) on all vials
produced after May 25, 2005. |
We remain committed to providing a high quality product that exceeds regulatory
standards. Please call if you have additional questions regarding our regulatory
compliance.
