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Notice2026-19080

Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method; Guidance for Industry; Availability

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Published
September 17, 2026

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled "Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method." The guidance document provides recommendations on the development of blood collection, processing, and storage systems (e.g., blood bags with anticoagulant and additive solutions, empty bags for platelet pooling) intended for the manufacture of blood and blood components for transfusion using the buffy coat (BC) method and on regulatory submissions to FDA for such products. This guidance is intended for manufacturers of blood collection, processing, and storage systems. The guidance announced in this notice finalizes the draft guidance of the same title dated October 18, 2024.

Full Text

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<title>Federal Register, Volume 91 Issue 179 (Thursday, September 17, 2026)</title>
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[Federal Register Volume 91, Number 179 (Thursday, September 17, 2026)]
[Notices]
[Pages 58906-58907]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-19080]



[[Page 58906]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-D-2732]


Recommendations for the Development of Blood Collection, 
Processing, and Storage Systems for the Manufacture of Blood Components 
Using the Buffy Coat Method; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance titled ``Recommendations for the 
Development of Blood Collection, Processing, and Storage Systems for 
the Manufacture of Blood Components Using the Buffy Coat Method.'' The 
guidance document provides recommendations on the development of blood 
collection, processing, and storage systems (e.g., blood bags with 
anticoagulant and additive solutions, empty bags for platelet pooling) 
intended for the manufacture of blood and blood components for 
transfusion using the buffy coat (BC) method and on regulatory 
submissions to FDA for such products. This guidance is intended for 
manufacturers of blood collection, processing, and storage systems. The 
guidance announced in this notice finalizes the draft guidance of the 
same title dated October 18, 2024.

DATES: The announcement of the guidance is published in the Federal 
Register on September 17, 2026.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
    <bullet> If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
    <bullet> Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    <bullet> For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2024-D-2732 for ``Recommendations for the Development of Blood 
Collection, Processing, and Storage Systems for the Manufacture of 
Blood Components Using the Buffy Coat Method.'' Received comments will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
    <bullet> Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the 
Office of Communication, Outreach and Development, Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3103, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist the office in processing 
your requests. The guidance may also be obtained by mail by calling 
CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Melissa Segal, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance titled 
``Recommendations for the Development of Blood Collection, Processing, 
and Storage Systems for the Manufacture of Blood Components Using the 
Buffy Coat Method.'' This guidance provides recommendations on the 
development of blood collection, processing, and storage systems (e.g., 
blood bags with anticoagulant and additive solutions, empty bags for 
platelet pooling) intended for the manufacture of blood and blood 
components for transfusion using the BC method and on regulatory 
submissions to FDA for such products. This guidance is intended for 
manufacturers of blood collection, processing, and storage systems.
    Blood and blood components must be prepared in a manner consistent 
with

[[Page 58907]]

the instructions provided by the manufacturer (21 CFR 606.65(e)), 
including the directions provided in the instructions for use of the 
approved or cleared collection, processing, and storage system. To 
prepare blood components using the BC method, blood establishments must 
use blood collection, processing and storage systems approved or 
cleared for such use.
    This guidance provides recommendations to manufacturers who wish to 
obtain FDA approval or clearance to market blood collection, 
processing, and storage systems intended for the manufacture of blood 
components for transfusion using the BC method. With the availability 
of such FDA-approved or cleared systems, blood establishments in the 
United States would have the option of manufacturing Whole Blood-
derived blood components using the BC method and licensed blood 
establishments could submit Biologics License Application (BLA) 
supplements to FDA.
    In the Federal Register of October 18, 2024, (89 FR 83886), FDA 
announced the availability of the draft guidance of the same title 
dated October 18, 2024. FDA received several comments on the draft 
guidance and those comments were considered as the guidance was 
finalized. In response to comments received, FDA made several 
clarifying edits. For example, FDA made clarifying revisions regarding 
timeframes for overnight ambient temperature holds, use of additive 
solutions that are currently not approved by FDA, and efforts to 
transition to systems that do not contain di(2-ethylhexyl) phthalate 
(DEHP). In addition, editorial changes were made to improve clarity. 
The guidance announced in this notice finalizes the draft guidance 
dated October 18, 2024.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Recommendations for the Development of 
Blood Collection, Processing, and Storage Systems for the Manufacture 
of Blood Components Using the Buffy Coat Method.'' It does not 
establish any rights for any person and is not binding on FDA or the 
public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no new collections of information, it 
does refer to previously approved FDA collections of information. The 
previously approved collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information 
in 21 CFR part 312.47 relating to the submission of investigational new 
drug applications and related meetings, including pre-IND meetings, 
``pre-NDA'' stages, and pre-new drug application meetings, have been 
approved under OMB control number 0910-0014. The collections of 
information in 21 CFR part 314.102 relating to submission of new drug 
marketing applications, as well as related meetings between sponsors or 
applicants and FDA or other communication with appropriate FDA 
officials to obtain advice and other information necessary to support 
submissions, and to discuss appropriate regulatory pathways, have been 
approved under OMB control number 0910-0001. The collections of 
information in 21 CFR part 601 pertaining to the submission of 
biologics license applications have been approved under OMB control 
number 0910-0338. The collections of information in 21 CFR part 807, 
subpart E relating to the submission of a premarket notification 
((510(k)) for a medical device have been approved under OMB control 
number 0910-0120. The collections of information in 21 CFR part 812 
relating to the submission of Investigational Device Exemption 
applications have been approved under OMB control number 0910-0078. The 
collections of information in 21 CFR part 814 relating to the 
submission of a premarket approval application (PMA) have been approved 
under OMB control number 0910-0231.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
<a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or 
<a href="https://www.regulations.gov">https://www.regulations.gov</a>.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-19080 Filed 9-16-26; 8:45 am]
BILLING CODE 4164-01-P


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