(a) The regulations in this part apply to human tissue and to establishments or persons engaged in the recovery, screening, testing, processing, storage, or distribution of human tissue.

(b) Regulations in this chapter as they apply to drugs, biologics, devices, or other FDA-regulated commodities do not apply to human tissue, except as specified in this part.

(c) Regulations in this chapter do not apply to autologous human tissue.

(d) Regulations in this chapter do not apply to hospitals or other clinical facilities that receive and store human tissue only for transplantation within the same facility.

(a) Act for the purpose of this part means the Public Health Service Act, section 361 (42 U.S.C. 264).

(b) Blood component means any part of a single-donor unit of blood separated by physical or mechanical means.

(c) Colloid means a protein or polysaccharide solution that can be used to increase or maintain osmotic (oncotic) pressure in the intravascular compartment such as albumin, dextran, hetastarch; or certain blood components, such as plasma and platelets.

(d) Contract services are those functions pertaining to the recovery, screening, testing, processing, storage, or distribution of human tissue that another establishment agrees to perform for a tissue establishment.

(e) Crystalloid means a balanced salt and/or glucose solution used for electrolyte replacement or to increase intravascular volume such as saline, Ringer's lactate solution, or 5 percent dextrose in water.

(f) Distribution includes any transfer or shipment of human tissue (including importation or exportation), whether or not such transfer or shipment is entirely intrastate and whether or not possession of the tissue is taken.

(g) Donor means a human being, living or dead, who is the source of tissue for transplantation.

(h) Donor medical history interview means a documented dialogue with an individual or individuals who would be knowledgeable of the donor's relevant medical history and social behavior; such as the donor if living, the next of kin, the nearest available relative, a member of the donor's household, other individual with an affinity relationship, and/or the primary treating physician. The relevant social history includes questions to elicit whether or not the donor met certain descriptions or engaged in certain activities or behaviors considered to place such an individual at increased risk for HIV and hepatitis.

(i) Establishment means any facility under one management including all locations, that engages in the recovery, screening, testing, processing, storage, or distribution of human tissue intended for transplantation.

(j) Human tissue, for the purpose of this part means any tissue derived from a human body and recovered before May 25, 2005, which:

(1) Is intended for transplantation to another human for the diagnosis, cure, mitigation, treatment, or prevention of any condition or disease;

(2) Is recovered, processed, stored, or distributed by methods that do not change tissue function or characteristics;

(3) Is not currently regulated as a human drug, biological product, or medical device;

(4) Excludes kidney, liver, heart, lung, pancreas, or any other vascularized human organ; and

(5) Excludes semen or other reproductive tissue, human milk, and bone marrow.

(k) Importer of record means the person, establishment or their representative responsible for making entry of imported goods in accordance with all laws affecting such importation.

(l) Legislative consent means relating to any of the laws of the various States that allow the medical examiner or coroner to procure corneal tissue in the absence of consent of the donor's next-of-kin.

(m) Person includes an individual, partnership, corporation, association, or other legal entity.

(n) Physical assessment means a limited autopsy or recent antemortem or postmortem physical examination of the donor to assess for any signs of HIV and hepatitis infection or signs suggestive of any risk factor for such infections.

(o) Plasma dilution means a decrease in the concentration of the donor's plasma proteins and circulating antigens or antibodies resulting from the transfusion of blood or blood components and/or infusion of fluids.

(p) Processing means any activity performed on tissue, other than tissue recovery, including preparation, preservation for storage, and/or removal from storage to assure the quality and/or sterility of human tissue. Processing includes steps to inactivate and remove adventitious agents.

(q) Quarantine means the identification of human tissue as not suitable for transplantation, including human tissue that has not yet been characterized as being suitable for transplantation. Quarantine includes the storage of such tissue in an area clearly identified for such use, or other procedures, such as automated designation, for prevention of release of such tissue for transplantation.

(r) Reconstituted blood means the extracorporeal resuspension of a blood unit labeled as “Red Blood Cells” by the addition of colloids and/or crystalloids to produce a hematocrit in the normal range.

(s) Recovery means the obtaining from a donor of tissue that is intended for use in human transplantation.

(t) Relevant medical records means a collection of documents including a donor medical history interview, a physical assessment of the donor, laboratory test results, medical records, existing coroner and autopsy reports, or information obtained from any source or records which may pertain to donor suitability regarding high risk behaviors, clinical signs and symptoms for HIV and hepatitis, and treatments related to medical conditions suggestive of such risk.

(u) Responsible person means a person who is authorized to perform designated functions for which he or she is trained and qualified.

(v) Storage means holding tissue.

(w) Summary of records means a condensed version of the required testing and screening records that contains the identity of the testing laboratory, the listing and interpretation of all required infectious disease tests, and a listing of the documents reviewed as part of the relevant medical records, and the name of the person or establishment determining the suitability of the human tissue for transplantation.

(x) Vascularized means containing the original blood vessels which are intended to carry blood after transplantation.

(a) Donor specimens shall be tested for the following communicable viruses, using Food and Drug Administration (FDA) licensed donor screening tests in accordance with manufacturers' instructions:

(1) Human immunodeficiency virus, Type 1 (e.g., FDA licensed screening test for anti-HIV-1);

(2) Human immunodeficiency virus, Type 2 (e.g., FDA licensed screening test for anti-HIV-2);

(3) Hepatitis B (e.g., FDA licensed screening test for HBsAg); and

(4) Hepatitis C (e.g., FDA licensed screening test for anti-HCV).

(b) In the case of a neonate, the mother's specimen is acceptable for testing.

(c) Such infectious disease testing shall be performed by a laboratory certified under the Clinical Laboratories Improvement Amendments of 1988 (CLIA).

(d) Human tissue shall be accompanied by records indicating that the donor's specimen has been tested and found negative using FDA licensed screening tests for HIV-1, HIV-2, hepatitis B, and hepatitis C. FDA licensed screening tests labeled for cadaveric specimens must be used when available.

(e) Human tissue for transplantation shall be accompanied by a summary of records or copies of the original records of the donor's relevant medical records as defined in § 1270.3(t) which documents freedom from risk factors for and clinical evidence of hepatitis B, hepatitis C, or HIV infection. There shall be a responsible person designated and identified in the original record and summary of records as having made the determination that the human tissue is suitable for transplantation.

(f) Determination by the responsible person that a donor of human tissue intended for transplantation is suitable shall include ascertainment of the donor's identity, and accurately recorded relevant medical records (as defined in § 1270.3(t)) which documents freedom from risk factors for and clinical evidence of hepatitis B, hepatitis C, and HIV infection.

(g) For corneal tissue procured under legislative consent where a donor medical history screening interview has not occurred, a physical assessment of the donor is required and other available information shall be reviewed. The corneal tissue shall be accompanied by the summary of records documenting that the corneal tissue was determined to be suitable for transplantation in the absence of the donor medical history interview. Corneal tissue procured under legislative consent shall be documented as such in the summary of records.

(h) Human tissue shall be determined to be not suitable for transplantation if from:

(1) A donor whose specimen has tested repeatedly reactive on a screening test for HIV, hepatitis B, or hepatitis C;

(2) A donor where blood loss is known or suspected to have occurred and transfusion/infusion of more than 2,000 milliliters (mL) of blood (i.e., whole blood, reconstituted blood, or red blood cells), or colloids within 48 hours; or more than 2,000 mL of crystalloids within 1 hour; or any combination thereof prior to the collection of a blood specimen from the tissue donor for testing, unless:

(i) A pretransfusion or preinfusion blood specimen from the tissue donor is available for infectious disease testing; or

(ii) An algorithm is utilized that evaluates the volumes administered in the 48 hours prior to collecting the blood specimen from the tissue donor to ensure that there has not been plasma dilution sufficient to affect test results; or

(3) A donor who is 12 years of age or less and has been transfused or infused at all, unless:

(i) A pretransfusion or preinfusion blood specimen from the tissue donor is available for infectious disease testing; or

(ii) An algorithm is utilized that evaluates the volumes administered in the 48 hours prior to collecting the blood specimen from the tissue donor to ensure that there has not been plasma dilution sufficient to affect test results.

(a) There shall be written procedures prepared and followed for all significant steps in the infectious disease testing process under § 1270.21 which shall conform to the manufacturers' instructions for use contained in the package inserts for the required tests. These procedures shall be readily available to the personnel in the area where the procedures are performed unless impractical. Any deviation from the written procedures shall be recorded and justified.

(b) There shall be written procedures prepared and followed for all significant steps for obtaining, reviewing, and assessing the relevant medical records of the donor as provided in § 1270.21. Such procedures shall be readily available to personnel who may perform the procedures. Any deviation from the written procedures shall be recorded and justified.

(c) There shall be written procedures prepared and followed for designating and identifying quarantined tissue.

(d) There shall be written procedures prepared, validated, and followed for prevention of infectious disease contamination or cross-contamination by tissue during processing.

(e) In conformity with this section, any facility may use current standard written procedures such as those in a technical manual prepared by another organization, provided the procedures are consistent with and at least as stringent as the requirements of this part.

(a) Records shall be maintained concurrently with the performance of each significant step required in this part in the performance of infectious disease screening and testing of donors of human tissue. All records shall be accurate, indelible, and legible. The records shall identify the person performing the work, the dates of the various entries, and shall be as detailed as necessary to provide a complete history of the work performed and to relate the records to the particular tissue involved.

(b) All human tissue shall be quarantined until the following criteria for donor suitability are satisfied:

(1) All infectious disease testing under § 1270.21 has been completed, reviewed by the responsible person, and found to be negative; and

(2) Donor screening has been completed, reviewed by the responsible person, and determined to assure freedom from risk factors for and clinical evidence of HIV infection, hepatitis B, and hepatitis C.

(c) All human tissue processed or shipped prior to determination of donor suitability must be under quarantine, accompanied by records assuring identification of the donor and indicating that the tissue has not been determined to be suitable for transplantation.

(d) All human tissue determined to be suitable for transplantation must be accompanied by a summary of records, or copies of such original records, documenting that all infectious disease testing and screening under § 1270.21 has been completed, reviewed by the responsible person, and found to be negative, and that the tissue has been determined to be suitable for transplantation.

(e) Human tissue shall be quarantined until the tissue is either determined to be suitable for transplantation or appropriate disposition is accomplished.

(f) All persons or establishments that generate records used in determining the suitability of the donor shall retain such records and make them available for authorized inspection or upon request by FDA. The person(s) or establishment(s) making the determination regarding the suitability of the donor shall retain all records, or true copies of such records required under § 1270.21, including all testing and screening records, and shall make them available for authorized inspection or upon request from FDA. Records that can be retrieved from another location by electronic means meet the requirements of this paragraph.

(g) Records required under this part may be retained electronically, or as original paper records, or as true copies such as photocopies, microfiche, or microfilm, in which case suitable reader and photocopying equipment shall be readily available.

(h) Records shall be retained at least 10 years beyond the date of transplantation if known, distribution, disposition, or expiration, of the tissue, whichever is latest.

Records shall be maintained that include, but are not limited to:

(a) Documentation of results and interpretation of all required infectious disease tests;

(b) Information on the identity and relevant medical records of the donor, as required by § 1270.21(e) in English or, if in another language translated to English and accompanied by a statement of authenticity by the translator which specifically identifies the translated document;

(c) Documentation of the receipt and/or distribution of human tissue; and

(d) Documentation of the destruction or other disposition of human tissue.

(a) An establishment covered by these regulations in this part, including any location performing contract services, shall permit an authorized inspector of the Food and Drug Administration (FDA) to make at any reasonable time and in a reasonable manner such inspection of the establishment, its facilities, equipment, processes, products, and records as may be necessary to determine compliance with the provisions of this part. Such inspections may be made with or without notice and will ordinarily be made during regular business hours.

(b) The frequency of inspection will be at the agency's discretion.

(c) The inspector shall call upon a responsible person of the establishment and may question the personnel of the establishment as the inspector deems necessary.

(d) The inspector may review and copy any records required to be kept pursuant to part 1270.

(e) The public disclosure of records containing the name or other positive identification of donors or recipients of human tissue will be handled in accordance with FDA's procedures on disclosure of information as set forth in 21 CFR part 20 of this chapter.

(a) When human tissue is offered for entry, the importer of record must notify the director of the district of the Food and Drug Administration having jurisdiction over the port of entry through which the tissue is imported or offered for import, or such officer of the district as the director may designate to act in his or her behalf in administering and enforcing this part.

(b) Human tissue offered for import must be quarantined until the human tissue is released by FDA.

(a) Upon a finding that human tissue may be in violation of the regulations in this part, an authorized Food and Drug Administration (FDA) representative may:

(1) Serve upon the person who distributed the tissue a written order that the tissue be recalled and/or destroyed, as appropriate, and upon persons in possession of the tissue that the tissue shall be retained until it is recalled by the distributor, destroyed, or disposed of as agreed by FDA, or the safety of the tissue is confirmed; and/or

(2) Take possession of and/or destroy the violative tissue.

(b) The written order will ordinarily provide that the human tissue be recalled and/or destroyed within 5 working days from the date of receipt of the order and will state with particularity the facts that justify the order.

(c) After receipt of an order under this part, the person in possession of the human tissue shall not distribute or dispose of the tissue in any manner except to recall and/or destroy the tissue consistent with the provisions of the order, under the supervision of an authorized official of FDA.

(d) In lieu of paragraphs (b) and (c) of this section, other arrangements for assuring the proper disposition of the tissue may be agreed upon by the person receiving the written order and an authorized official of FDA. Such arrangements may include providing FDA with records or other written information that adequately assure that the tissue has been recovered, screened, tested, processed, stored, and distributed in conformance with part 1270.

(e) Within 5 working days of receipt of a written order for retention, recall, and/or destruction of tissue (or within 5 working days of the agency's possession of such tissue), the recipient of the written order or prior possessor of such tissue shall request a hearing on the matter in accordance with part 16 of this chapter. The order for destruction will be held in abeyance pending resolution of the hearing request.