Part 1271 is organized into subparts. One covers donor eligibility, including the medical and social history screening and communicable disease testing a donor must undergo. Another covers current good tissue practice, the manufacturing and quality controls that apply to recovery, processing, storage and distribution. A separate section, 1271.10, lays out the criteria that decide which regulatory pathway a given HCT/P falls under.
FDA had exercised enforcement discretion for certain HCT/Ps for a period of time, but that discretion period ended on May 31, 2021. Since then, full compliance with Part 1271 has been the expectation for products in this category, and FDA has continued enforcement activity, including warning letters to distributors over claims made about tissue and exosome products.
For a buyer, Part 1271 is a useful checklist rather than an abstract regulation. It points to specific documents to request from a supplier: proof of establishment registration, a donor eligibility determination for the relevant donor, and lot-level processing and release records, each of which maps to a specific subpart of the regulation.
These products are not FDA approved or licensed for any disease or condition. Information is for licensed healthcare professionals and is not medical or legal advice.
Part 1271 gives a clinic a concrete documentation checklist, covering registration, donor eligibility and processing records, to request when qualifying any tissue supplier.