Blood Pressure and Pulse Donor 
Eligibility Requirements  Compliance 
Policy
 
 
   
Draft Guidance for Industry 
 
 
 
 
This guidance document is for comment purposes only. 
 
 
 
 
 
Submit one set of either electronic or written comments on this draft guidance by the date 
provided in the Federal Register notice announcing the availability of the draft guidance.  
Submit electronic comments to https://www.regulations.gov/.  Submit written comments to the 
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852.  You should identify all comments with the docket number listed in 
the notice of availability that publishes in the Federal Register. 
 
Additional copies of this guidance are available from the Office of Communication, Outreach 
and Development (OCOD), 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, 
MD 20993-0002, or by calling 1-800-835-4709 or 240-402-8010, or email ocod@fda.hhs.gov, or 
from the Internet at https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-
regulatory-information-biologics/biologics-guidances. 
 
For questions on the content of this guidance, contact OCOD at the phone numbers or email 
address listed above. 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Biologics Evaluation and Research 
May 2022  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
Table of Contents 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  DISCUSSION .................................................................................................................... 2 
IV.  DONOR BLOOD PRESSURE AND PULSE ELIGIBILITY REQUIREMENTS  
COMPLIANCE POLICY ................................................................................................ 3 
V.  IMPLEMENTATION ...................................................................................................... 5 
VI.  REFERENCES .................................................................................................................. 6 
i  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
Blood Pressure and Pulse Donor Eligibility Requirements  
Compliance Policy 
 
 
Draft Guidance for Industry 
 
 
This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
Administration (FDA or Agency) on this topic.  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.  To discuss an alternative approach, 
contact the FDA staff responsible for this guidance as listed on the title page.  
 
 
I.  INTRODUCTION 
 
This guidance addresses the regulatory requirements for determining donor eligibility that apply 
to establishments that collect blood and blood components (blood establishments) for transfusion 
or for further manufacturing use, including Source Plasma.  In the final rule dated May 22, 2015 
(Requirements for Blood and Blood Components Intended for Transfusion or for Further 
Manufacturing Use (donor eligibility rule)) (Ref. 1), FDA (we) amended the regulations 
applicable to blood establishments for determining donor eligibility and testing blood and blood 
components.  The revised requirements were implemented in order to assure the safety of the 
blood supply and to protect donor health.  The donor eligibility rule became effective on May 23, 
2016. 
 
FDA has developed this guidance in response to feedback from blood establishments regarding 
the donor eligibility requirements for blood pressure and pulse in Title 21 of the Code of Federal 
Regulations 630.10 (21 CFR 630.10) and the corresponding requirements for medical 
supervision in 21 CFR 630.5.  This guidance describes the circumstances in which FDA does not 
intend to take regulatory action for a blood establishments failure to comply with certain 
regulations for determining the eligibility of blood donors with blood pressure or pulse 
measurements outside of the specified limits.   
 
The contents of this document do not have the force and effect of law and are not meant to bind 
the public in any way, unless specifically incorporated into a contract.  This document is 
intended only to provide clarity to the public regarding existing requirements under the law. 
FDA guidance documents, including this guidance, should be viewed only as recommendations, 
unless specific regulatory or statutory requirements are cited.  The use of the word should in 
FDA guidances means that something is suggested or recommended, but not required. 
 
 
1  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
II.  BACKGROUND 
 
In November 2009, FDA held a Blood Products Advisory Committee (BPAC or Committee) 
meeting to seek the Committees advice on, among other things, whether available data support 
the utility of obtaining predonation blood pressure and pulse measurements as predictors of the 
risk of adverse response to donation (Ref. 2).  The majority of the Committee responded that data 
did not establish predonation blood pressure as a predictor of risk of an adverse response; the 
Committee was divided on whether pulse measurement was a predictor of adverse reactions.  
However, many members of the committee stated that pulse and blood pressure measurement 
should be retained as part of the donor assessment.  The committee expressed concern for the 
health of donors with blood pressure outside the specified limits, noting the lack of data on the 
safety of blood donations by individuals with unusually high or low blood pressure.  Several 
members raised concerns of an association between high pulse rates and increased rates of 
vasovagal reactions.  However, it was noted that data have shown that donors with low pulse 
rates are not at increased risk of reactions.  This finding likely reflected standard practice at the 
time to accept donors with low pulse (<50 bpm) only if they reported being otherwise healthy 
athletes.  
 
In May 2015, FDA published the donor eligibility rule and finalized the requirements for blood 
pressure and pulse limits (Ref. 1).  The regulations for blood pressure and pulse limits allow for 
donation by donors with measurements outside the specified limits if, among other things, the 
responsible physician determines that their health would not be adversely affected by donating 
(21 CFR 630.10(f)(2); 21 CFR 630.10(f)(4)).  
 
Current FDA donor eligibility regulations require that on the day of donation and before 
collection, a donors systolic blood pressure must not measure above 180 mm of mercury or 
below 90 mm of mercury, and diastolic blood pressure must not measure above 100 mm of 
mercury or below 50 mm of mercury (21 CFR 630.10(f)(2)).  A donor with measurements 
outside these limits may be permitted to donate only when the responsible physician examines 
the donor and determines and documents that the health of the donor would not be adversely 
affected by donating (21 CFR 630.10(f)(2)).  This examination and determination must not be 
delegated (21 CFR 630.5(b) and (c)).  
 
In addition, on the day of donation and before collection, a donors pulse must be regular and 
between 50 and 100 beats per minute (bpm) (21 CFR 630.10(f)(4)).  If pulse is irregular or the 
rate falls outside the specified limits, the donor may be permitted to donate only when the 
responsible physician determines and documents that the health of the donor would not be 
adversely affected by donating (21 CFR 630.10(f)(4)).  This determination must not be delegated 
but may be performed by telephonic or other offsite consultation (21 CFR 630.5(b) and (c)). 
 
 
III.  DISCUSSION  
 
Following publication of the donor eligibility rule, FDA approved standard operating procedures 
(SOPs) from individual blood establishments that allowed for a one-time determination by the 
2  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
responsible physician that the health of the donor would not be adversely affected by donating 
for athletic donors with a pulse rate less than 50 beats per minute (bpm).  Based on this one-time 
determination by the responsible physician, the donor would not be disqualified on the basis of 
such pulse rate for future donations.   
 
However, FDA continues to receive feedback from stakeholders that the requirement in 21 CFR 
630.10(f)(4) for the responsible physician to make a determination of the donors health for 
donors with pulse measurements less than 50 bpm or donors with irregular pulse and the 
requirement in 21 CFR 630.10(f)(2) for the responsible physician to examine and make a 
determination of the donors health for donors with blood pressure measurements outside the 
specified limits are burdensome and not necessary to protect donor health.  In addition, 
stakeholders have reported the requirements result in the deferral of many healthy blood donors 
because the responsible physician is often not available for the examination or to make the 
determination of health.    
 
FDA has considered these comments and agrees that some flexibility is warranted with respect to 
the responsible physicians medical oversight.  Specifically, we agree that having a responsible 
physician examine a donor with blood pressure measurements outside the specified limits is not 
always necessary to protect donor health.  While blood pressure measurements outside the 
specified limits may indicate that a donor is not healthy, donor health is adequately protected 
when the responsible physician makes a medical determination by telephonic or other offsite 
consultation that the donation will not adversely affect the health of the donor and documents 
that determination.   
 
Further, we agree that for individuals with a pulse measurement below 50 bpm who report being 
healthy athletes and for individuals with an irregular pulse, consultation with the responsible 
physician is not always necessary to protect donor health.  Specifically, donor health can be 
adequately protected when individuals with pulse measurements below 50 bpm who report being 
healthy athletes are considered eligible without consultation with the responsible physician.  
Further, while an irregular pulse may indicate that a donor is not healthy, donor health can be 
adequately protected when individuals with an irregular pulse are considered eligible without 
consultation with the responsible physician.    
 
 
IV.  DONOR BLOOD PRESSURE AND PULSE ELIGIBILITY REQUIREMENTS  
COMPLIANCE POLICY 
 
This guidance describes the circumstances in which FDA does not intend to take regulatory 
action regarding requirements to determine donor eligibility based on blood pressure and pulse 
measurement. 
 
A.  Blood Pressure (21 CFR 630.10(f)(2)) 
 
For a donor with blood pressure measurements outside of the specified limits (90-180 
mm Hg systolic or 50-100 mm Hg diastolic), we do not intend to take regulatory action 
3  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
with respect to the requirement in 21 CFR 630.10(f)(2) that the donor may be permitted 
to donate only when the responsible physician examines the donor, when the responsible 
physician conducts a telephonic or other offsite consultation, and determines and 
documents that the health of the donor would not be adversely affected by donating.  
Consistent with 21 CFR 630.5(b)(1)(i)(A) and 21 CFR 630.5(c)(1)(i)(A)(1), the 
responsible physician must not delegate this determination of the donors health. 
 
B.  Pulse (21 CFR 630.10(f)(4)) and Medical Supervision (21 CFR 
630.5(b)(1)(i)(B) and 21 CFR 630.5(c)(1)(i)(A)(2)) 
 
For a donor with a pulse measurement below 50 bpm who self-reports being a healthy 
athlete, we do not intend to take regulatory action with respect to the requirement in 21 
CFR 630.10(f)(4) that the donor may be permitted to donate only when the responsible 
physician determines and documents that the health of the donor would not be adversely 
affected by donating, and the requirements in 21 CFR 630.5(b)(1)(i)(B) and 21 CFR 
630.5(c)(1)(i)(A)(2) that the responsible physician must not delegate this determination 
of the donors health.  We intend to apply this compliance policy when the blood 
establishment establishes, maintains and follows SOPs1 that: 
 
  are approved by the responsible physician of the blood establishment; and,   
  
  allow for donation by a donor with a pulse measurement below 50 bpm who self-
reports being a healthy athlete without consultation with the responsible 
physician.  
 
For a donor with an irregular pulse, we do not intend to take regulatory action with 
respect to the requirement in 21 CFR 630.10(f)(4) that the donor may be permitted to 
donate only when the responsible physician determines and documents that the health of 
the donor would not be adversely affected by donating, and the requirements in 21 CFR 
630.5(b)(1)(i)(B) and 21 CFR 630.5(c)(1)(i)(A)(2) that the responsible physician must 
not delegate this determination of the donors health.  We intend to apply this compliance 
policy when the blood establishment establishes, maintains, and follows SOPs that: 
 
  are approved by the responsible physician of the blood establishment; and,  
 
  define medical criteria for donation by a donor with an irregular pulse without 
consultation with the responsible physician. 
 
 
 
   
 
1 Note:  Blood establishments must establish, maintain and follow written procedures for all steps in the collection of 
blood and blood components, including criteria used to determine donor eligibility (see 21 CFR 606.100(b)). 
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V.  IMPLEMENTATION 
 
Licensed blood establishments must report changes to their SOPs made in accordance 
with this guidance as Changes Being Effected (CBE) supplements under 21 CFR 
601.12(c)(5).  See 21 CFR 601.12(a)(3).  
 
   
5  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
 
VI.  REFERENCES  
 
1.  Requirements for Blood and Blood Components Intended for Transfusion or for Further 
Manufacturing Use, Final Rule, May 22, 2015, 80 FR 29841, available at: 
https://www.federalregister.gov/documents/2015/05/22/2015-12228/requirements-for-
blood-and-blood-components-intended-for-transfusion-or-for-further-manufacturing. 
 
2.  FDA Blood Products Advisory Committee, November 17, 2009, Transcript available at:  
https://wayback.archive-
it.org/7993/20170406174346/https://www.fda.gov/AdvisoryCommittees/CommitteesMee
tingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/ucm
276284.htm. 
 
 
  
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