Reproductive Cells and Tissues Labeling Matrix
The labeling recommendations summarized in the matrix below are intended solely as an aid to the client indetermining appropriate labeling for reproductive HCT/Ps. It should be used as augmentation to the actual FDA
regulations and guidance documents.
Eligibility
StatusDonor
Eligibility
Not
RequiredStorage Labeling*
Autologous Use:
1.

“FOR AUTOLOGOUS USE ONLY”;
and2.

“NOT EVALUATED FOR
INFECTIOUS SUBSTANCES”(Unless you have performed allscreening/testing).

HCT/P Container Labeling (inaddition to Yws storage labeling)Distribution Labeling(in addition tostorage labeling)

1. A distinct identifier (i.e., number,name, medical record number,etc.) that relates the HCT/P to allapplicable records.

Sexually Intimate Partner (SIP):
1.

“NOT EVALUATED FOR
INFECTIOUS SUBSTANCES”(Unless you have performed allscreening/testing); and2.

“WARNING: Advise patient ofcommunicable disease risks”(If screening/testing has notbeen performed, or if results ofscreening/testing indicate presenceof risk factor for communicabledisease); andIf screening and testing was performed,
additional warning labeling if
applicable:
1. “WARNING: Reactive test results for(name of disease)”
2. Biohazard Legend (if results oftesting or screening indicate
presence of risk factor forcommunicable disease).

*Where physically impossible to include warnings on container labels, warning may be placed on labeling that
accompanies the HCT/P. FDA has acknowledged this necessity because the containers for some HCT/Ps, such as thoseused for semen cryopreservation, are so small that they do not accommodate the warning language. In addition, the useof a tie-tag with warning language may not be feasible because it is difficult to securely attach to a container stored inliquid nitrogen. In such cases, the warning language may accompany the HCT/P.
ADDITIONAL LABELING:
If reproductive tissue will be donated to a directed recipient under 1271.90(a)(3) or a directed or anonymous donation
Should be under 1271.90(a)(4) or 1271.90(b), and the screening and testing is performed before transfer to the recipient
rather than at the time of recovery, then under 1271.90(c)(6) you must label the HCT/P: “Advise recipient that screeningand testing of the donors were not performed at the time of cryopreservation of the reproductive cells or tissue, but havebeen performed subsequently.”
1 | © Copyright 2023 EVERSANA | EVERSANA.COM

DonorEligibility
Pending

Donor
Eligible

Donor
Ineligible

1.

Quarantine: Donor Eligibility
Determination Not Complete

1.

Eligible HCT/Ps

2.

Records referenced in 1271.55 must
accompany an HCT/P at all times.

1. Quarantine: Ineligible HCT/Ps
2. “WARNING: Advise patient ofcommunicable disease risks”; and3. Biohazard Legend.
4. Records referenced in 1271.55 must
accompany an HCT/P at all times.
If testing was reactive:
1. “WARNING: Reactive test results for(name of disease agent or disease)”.

NonClinicalUse

1. “For Non-Clinical Use Only”; and2. Biohazard Legend.

1.

For Autologous, SIP, Directed
Donation: A distinct identifier(i.e., number, name, medical
record number, etc.) that
relates the HCT/P to allapplicable records.

2.

For Anonymous Donation:
A distinct identification
code (i.e., does not reveal
information that could be used
to identify the donor) affixed
to the container that relates
the HCT/P to all applicablerecords.

1.

For Autologous, SIP, Directed
Donation: A distinct identifier(i.e., number, name, medical
record number, etc.) that
relates the HCT/P to allapplicable records.

2.

For Anonymous Donation:
A distinct identification
code (i.e., does not reveal
information that could be used
to identify the donor) affixed
to the container that relates
the HCT/P to all applicablerecords.

1. For Autologous, SIP, Directed
Donation: A distinct identifier(i.e., number, name, medical
record number, etc.) that relates
the HCT/P to all applicablerecords.
2. For Anonymous Donation: A
distinct identification code (i.e.,does not reveal information that
could be used to identify thedonor) affixed to the containerthat relates the HCT/P to allapplicable records

1.

HCT/P must not
be implanted,transplanted,infused ortransferred
until the donor
eligibility
determination iscomplete.

1.

Records
referenced in
1271.55 must
accompany an
HCT/P whenplaced intodistribution.

1. Records
referenced in
1271.55 must
accompany an
HCT/P whenplaced intodistribution.

1. A distinct identifier that relates
the HCT/P to all applicablerecords.

*Where physically impossible to include warnings on container labels, warning may be placed on labeling thataccompanies the HCT/P. FDA has acknowledged this necessity because the containers for some HCT/Ps, such as thoseused for semen cryopreservation, are so small that they do not accommodate the warning language. In addition, the useof a tie-tag with warning language may not be feasible because it is difficult to securely attach to a container stored inliquid nitrogen. In such cases, the warning language may accompany the HCT/P.
ADDITIONAL LABELING:
If reproductive tissue will be donated to a directed recipient under 1271.90(a)(3) or a directed or anonymous donation
Should be under 1271.90(a)(4) or 1271.90(b), and the screening and testing is performed before transfer to the recipient
rather than at the time of recovery, then under 1271.90(c)(6) you must label the HCT/P: “Advise recipient that screening
and testing of the donors were not performed at the time of cryopreservation of the reproductive cells or tissue, but havebeen performed subsequently.”
2 | © Copyright 2023 EVERSANA | EVERSANA.COM