What the regulation is
21 CFR Part 1271 is the section of the Code of Federal Regulations governing HCT/Ps. It sets out registration requirements, donor eligibility criteria, and current good tissue practice.
It is publicly readable. Anyone can look it up, and doing so is more reliable than accepting a clinic's characterisation of it.
What it requires
Registration and listing — establishments that manufacture HCT/Ps must register with FDA and list their products. This is a notification requirement, not an approval process.
Donor eligibility — screening for risk factors and testing for relevant communicable diseases, with specified documentation.
Current good tissue practice — controls on facilities, equipment, processing, labelling, storage and distribution, aimed at preventing contamination and cross-contamination.
Tracking — the ability to trace a product from donor to recipient and back.
What it does not require
It does not require demonstration of clinical efficacy. It does not require controlled trials. It does not involve FDA review or approval of a product's performance for any indication.
This is the single most misunderstood point in the field, and the source of the confusion addressed in the next article.
This article covers general science and published research. Whether any approach is appropriate for you is a clinical question, answered by a licensed provider through a good-faith exam.
Movera Wellness Institute. Medical services are provided by licensed California practitioners. Supervising physician: Dr. Arnold S. Kremer, DO (CA license #20A4242).