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Notice2026-19147

Request for Information (RFI) on Future Needs for Medical Metrology and Standards for Medical Imaging, Devices, Diagnostics and Therapy

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Published
September 18, 2026

Issuing agencies

Commerce DepartmentNational Institute of Standards and Technology

Abstract

The National Institute of Standards and Technology (NIST) and the National Institute of Biomedical Imaging and Bioengineering (NIBIB), a part of the National Institutes of Health (NIH), are requesting input from stakeholders in order to gain a better understanding of the future needs for medical metrology and standards around medical imaging, devices, and diagnostics. This request for information is coordinated with a NIST/NIBIB Symposium on Medical Metrology and Standards for American Healthcare and Commerce Medical Imaging, Devices, Diagnostics at the joint NIST/University of Maryland Institute (UMD) for Bioscience and Biotechnology Research (IBBR). The input received will inform a joint NIST and NIBIB medical metrology and standards roadmap, a document that will identify future needs for medical metrology and standards, identify major stakeholders, and provide guidance for future government programs.

Full Text

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<title>Federal Register, Volume 91 Issue 180 (Friday, September 18, 2026)</title>
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[Federal Register Volume 91, Number 180 (Friday, September 18, 2026)]
[Notices]
[Pages 59111-59113]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-19147]


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DEPARTMENT OF COMMERCE

National Institute of Standards and Technology

[Docket Number: 260909-0004]


Request for Information (RFI) on Future Needs for Medical 
Metrology and Standards for Medical Imaging, Devices, Diagnostics and 
Therapy

AGENCY: Physical Measurement Laboratory (PML), National Institute of 
Standards and Technology (NIST), U.S. Department of Commerce.

ACTION: Notice of public meeting; request for information (RFI).

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SUMMARY: The National Institute of Standards and Technology (NIST) and 
the National Institute of Biomedical Imaging and Bioengineering 
(NIBIB), a part of the National Institutes of Health (NIH), are 
requesting input from stakeholders in order to gain a better 
understanding of the future needs for medical metrology and standards 
around medical imaging, devices, and diagnostics. This request for 
information is coordinated with a NIST/NIBIB Symposium on Medical 
Metrology and Standards for American Healthcare and Commerce Medical 
Imaging, Devices, Diagnostics at the joint NIST/University of Maryland 
Institute (UMD) for Bioscience and Biotechnology Research (IBBR). The 
input received will inform a joint NIST and NIBIB medical metrology and 
standards roadmap, a document that will identify future needs for 
medical metrology and standards, identify major stakeholders, and 
provide guidance for future government programs.

DATES: 

Symposium

    The NIST/NIBIB Symposium on Medical Metrology and Standards for 
American Healthcare and Commerce Medical Imaging, Devices, Diagnostics, 
and Therapy will be held on Thursday, September 24, 2026, from 8:45 
a.m. to 5:30 p.m. Requests to participate must be submitted via the 
symposium website at <a href="https://www.nist.gov/news-events/events/2026/09/nistnibib-symposium-medical-metrology-and-standards-american-healthcare">https://www.nist.gov/news-events/events/2026/09/nistnibib-symposium-medical-metrology-and-standards-american-healthcare</a> 
no later than 5:00 p.m. Eastern Time on Friday, September 11, 2026 for 
in-person attendance, and 5:00 p.m. Eastern Time on Tuesday, September 
22, 2026 for virtual attendance. To request to participate, go to the 
symposium website, click on ``Register Here'' button, and follow the 
instructions listed.

Comments in Response to Request for Information

    Comments in response to this notice must be received on or before 
November 30, 2026, at 11:59 p.m. Eastern Time. Written comments in 
response to this notice should be submitted in accordance with the 
instructions in the ADDRESSES and SUPPLEMENTARY INFORMATION sections 
below. Submissions received after this date may not be considered.

ADDRESSES: 

Symposium

    Details about attending the NIST-NIBIB Symposium on Medical 
Metrology and Standards on September 24, 2026, can be found on the 
Symposium website at <a href="https://www.nist.gov/news-events/events/2026/09/nistnibib-symposium-medical-metrology-and-standards-american-healthcare">https://www.nist.gov/news-events/events/2026/09/nistnibib-symposium-medical-metrology-and-standards-american-healthcare</a>. To register, go to the event website, click on ``Register 
Here'' button, and follow the instructions listed. Registrants will 
need to provide their full name, affiliation, email address, and 
whether they are attending virtually or in person. They will need to 
indicate if they are an invited speaker, want to present a poster (and 
give a title of presentation), or need a display table. Optional 
emergency information and special needs can be specified.

Comments in Response To Request for Information

    Comments can be submitted at <a href="http://www.regulations.gov">www.regulations.gov</a> following the 
instructions below:
    Interested parties can submit electronic public comments via the 
Federal e-Rulemaking Portal.
    1. Go to <a href="http://www.regulations.gov">www.regulations.gov</a> and enter NIST-2026-0133 in the search 
field;
    2. Click the ``Comment Now!'' icon, complete the required fields, 
including the relevant docket number and title in the subject field; 
and
    3. Enter or attach your comments.
    Additional information on the use of <a href="http://regulations.gov">regulations.gov</a>, including 
instructions for accessing agency documents, submitting comments, and 
viewing the docket is available at <a href="http://www.regulations.gov/faq">www.regulations.gov/faq</a>. If you 
require an accommodation or cannot otherwise submit your comments via 
<a href="http://regulations.gov">regulations.gov</a>, please contact NIST using the information in the FOR 
FURTHER INFORMATION CONTACT section below.
    NIST will not accept comments for this notice by postal mail, 
email, or fax. To ensure that NIST does not receive duplicate copies, 
please submit your comments only once. Comments containing references, 
studies, research, and other empirical data that are not widely 
published should include copies of the reference materials.
    NIST will also not accept comments accompanied by a request that 
part or all the material be treated confidentially because of its 
business proprietary nature or for any other reason. Therefore, do not 
submit confidential business information or otherwise sensitive, 
protected, or personal information, such as account numbers, Social 
Security numbers, or names of other individuals.
    All submissions, including comments, attachments and other 
supporting materials, will become part of the public record and subject 
to public disclosure. All relevant comments received by the deadline 
will be posted at: <a href="https://www.regulations.gov">https://www.regulations.gov</a> under docket number 
NIST-2026-0133 without change or redaction.

FOR FURTHER INFORMATION CONTACT: Stephen Russek, Project Leader: 
Magnetic Imaging, 325 Broadway, Boulder, CO; email: 
<a href="/cdn-cgi/l/email-protection#66151203160e03084814131515030d26080f151248010910"><span class="__cf_email__" data-cfemail="89fafdecf9e1ece7a7fbfcfafaece2c9e7e0fafda7eee6ff">[email&#160;protected]</span></a>; phone: 303-497-5097. Direct

[[Page 59112]]

media inquiries to NIST's Office of Public Affairs at (301) 975-2762.
    Users of telecommunication devices for the deaf, or a text 
telephone may call the Federal Relay Service toll free at 1-800-877-
8339. NIST will make the RFI available in alternate formats, such as 
Braille or large print, upon request by persons with disabilities.

SUPPLEMENTARY INFORMATION:

Background

    Healthcare accounts for 18% of the GDP in the US and is projected 
to increase to 20.6% by 2034.\1\ It is one of the most socially and 
commercially important sectors in our economy. Critical components of 
the healthcare infrastructure are the underlying measurements that are 
required for accurate screening and diagnostic evaluations and 
subsequent therapeutic planning and application. Metrology refers to 
the science of establishing precise reproducible measurements with 
well-defined uncertainties. A variety of measurement standards exist to 
ensure measurements are accurate, precise, comparable across all 
involved sites, and durable over time. Most of the standards are 
consensus standards established by a large body of stakeholders 
including professional societies and standards organizations. 
Government agencies, such as NIST, assist where primary traceability 
and validation are required.
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    \1\ `NHE Fact Sheet [verbar] CMS', n.d. <<a href="https://www.cms.gov/data-research/statistics-trends-and-reports/national-health-expenditure-data/nhe-fact-sheet">https://www.cms.gov/data-research/statistics-trends-and-reports/national-health-expenditure-data/nhe-fact-sheet</a>> [accessed 16 August 2026].
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    To help ensure that future medical measurements and standards are 
developed appropriately and efficiently, a NIST/NIBIB Symposium on 
Medical Metrology and Standards for American Healthcare and Commerce 
Medical Imaging, Devices, Diagnostics will be held on September 24, 
2026 at the joint NIST/UMD Institute for Bioscience and Biotechnology 
Research (IBBR), 9600 Gudelsky Dr, Rockville, MD 20850.
    NIST, along with other government agencies, have hosted workshops 
in the past on different aspects of medical metrology resulting in 
highly cited documents.\2\ With the advent of rapidly advancing medical 
technology and artificial intelligence (AI), the future requirements 
for medical metrology and standards may change considerably. Agility 
and evolving standards may be required to address a rapidly changing US 
healthcare system. Better medical metrology and standards are expected 
to be an important component of the healthcare infrastructure allowing 
for improved and cost-effective healthcare.
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    \2\ Laurence P. Clarke, Ram D. Sriram, and Linda Beth Schilling, 
`Imaging as a Biomarker: Standards for Change Measurements in 
Therapy Workshop Summary', Academic Radiology, 15.4 (2008), pp. 501-
30, doi:10.1016/j.acra.2007.10.021; Megan H. Cleveland and others, 
`Report of the 2019 NIST-FDA Workshop on Standards for next 
Generation Sequencing Detection of Viral Adventitious Agents in 
Biologics and Biomanufacturing', Biologicals: Journal of the 
International Association of Biological Standardization, 64 (2020), 
pp. 76-82, doi:10.1016/j.biologicals.2020.02.003; J. C. Chiao and 
others, `Metrology and Standards Needs for Some Categories of 
Medical Devices', Journal of Research of the National Institute of 
Standards and Technology, 113.2 (2008), p. 121, doi:10.6028/
jres.113.009.
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Symposium

    The NIST/NIBIB Symposium on Medical Metrology and Standards for 
American Healthcare and Commerce Medical Imaging, Devices, Diagnostics 
will be held as indicated in the DATES and ADDRESSES section. Requests 
to participate must be received via the symposium website at <a href="https://www.nist.gov/news-events/events/2026/09/nistnibib-symposium-medical-metrology-and-standards-american-healthcare">https://www.nist.gov/news-events/events/2026/09/nistnibib-symposium-medical-metrology-and-standards-american-healthcare</a> no later than 5:00 p.m. 
Eastern Time on Friday, September 11, 2026 for in person attendance, 
and 5:00 p.m. Eastern Time on Tuesday, September 22, 2026 for virtual 
attendance. The symposium will be recorded and transcribed for internal 
NIST use only.
    The NIST/NIBIB symposium is meant to be a general meeting with a 
wide selection of stakeholders. There will be invited speakers who have 
a very broad range of expertise and will include representatives from 
clinical sites, government, industry, professional societies, and 
academia. The goal of the speakers is to highlight the role of medical 
metrology and standards in their work, discuss future directions and 
challenges, and potentially show how their work overlaps with the 
broader medical metrology and standards framework needed for the US 
healthcare system. At the end of each session, there will be panel 
discussions where the speakers can address questions and discuss common 
themes. Between sessions, there will be a break and poster 
presentations from researchers, standards organizations, and companies 
providing medical metrology and standards.
    The final agenda will be posted on the Symposium website <a href="https://www.nist.gov/news-events/events/2026/09/nistnibib-symposium-medical-metrology-and-standards-american-healthcare">https://www.nist.gov/news-events/events/2026/09/nistnibib-symposium-medical-metrology-and-standards-american-healthcare</a> in a downloadable pdf file, 
along with directions to the IBBR site and suggested local 
accommodations. Information regarding the virtual attendance link and 
parking vouchers will be sent to registrants after registration is 
completed.
    All visitors attending the Symposium on the joint NIST/University 
of Maryland Institute (UMD) for Bioscience and Biotechnology Research 
(IBBR) site are required to pre-register to be admitted. Presentation 
of ID, driver's license or passport will be required to pick up badge 
and enter. Limited space is available on a first-come, first-served 
basis for anyone who wishes to attend in person. For detailed 
information please visit: <a href="https://www.ibbr.umd.edu/events/visiting-ibbr">https://www.ibbr.umd.edu/events/visiting-ibbr</a>.
    NIST provides reasonable accommodation to individuals with 
disabilities where appropriate. If you are a person who requires a 
reasonable accommodation, please make requests in advance for sign 
language interpretation, assistive listening devices, or other 
reasonable accommodation to Sabina Mohan, Conference Program 
Specialist, <a href="/cdn-cgi/l/email-protection#ee9d8f8c87808fc08381868f80ae80879d9ac0898198"><span class="__cf_email__" data-cfemail="7d0e1c1f14131c531012151c133d13140e09531a120b">[email&#160;protected]</span></a>, no later than 5:00 p.m. Eastern Time 
on September 11, 2026, so appropriate arrangements can be made. 
Determinations for reasonable accommodation will be made on a case-by-
case basis.

Request for Information

    In this notice, NIST and NIBIB seek information from organizations, 
companies, and individuals who are impacted by medical metrology and 
standards in the areas of Medical Imaging, Devices, Diagnostics and 
Therapy as well as any other interested stakeholders.
    Respondents need not address all topic areas described in this 
notice, though all responses should specify which statements are being 
responded to. All relevant responses that comply with the requirements 
listed in the DATES and ADDRESSES sections of this RFI will be 
considered.
    NIST and NIBIB seek information on the following topic areas, 
including but not limited to:
    <bullet> Areas where there is a need for improved medical 
measurements relating to medical imaging, devices, diagnostics and 
therapy and how we can provide the needed standards and validation of 
these measurements.
    <bullet> Identification of future medical standards efforts for new 
measurement areas that may not be currently addressed.
    <bullet> Suggested changes to the medical metrology and standards 
process to allow improved and cost-effective healthcare in a time of 
rapidly changing technology and incorporation of AI.

[[Page 59113]]

    <bullet> Examples of how medical metrology and standards have 
improved diagnostics, therapeutic outcomes, and cost efficiency. 
Examples where they are detrimental.
    Authority: 15 U.S.C. 272(b) and 272(c).

Alicia Chambers,
NIST Executive Secretariat.
[FR Doc. 2026-19147 Filed 9-17-26; 8:45 am]
BILLING CODE 3510-13-P


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