Document

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

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 Healt...

PDF version FederalRegister.gov

Department of Commerce

National Institute of Standards and Technology

[Docket Number: 260909-0004]

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).

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 www.nist.gov/news-events/events/2026/09/nistnibib-symposium-medical-metrology-and-standards-american-healthcare 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 www.nist.gov/news-events/events/2026/09/nistnibib-symposium-medical-metrology-and-standards-american-healthcare. 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 www.regulations.gov following the instructions below:

Interested parties can submit electronic public comments via the Federal e-Rulemaking Portal.

1. Go to www.regulations.gov 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 regulations.gov, including instructions for accessing agency documents, submitting comments, and viewing the docket is available at www.regulations.gov/faq. If you require an accommodation or cannot otherwise submit your comments via regulations.gov, 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: www.regulations.gov 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: stephen.russek@nist.gov; phone: 303-497-5097. Direct ( printed 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.

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.

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 www.nist.gov/news-events/events/2026/09/nistnibib-symposium-medical-metrology-and-standards-american-healthcare 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 www.nist.gov/news-events/events/2026/09/nistnibib-symposium-medical-metrology-and-standards-american-healthcare 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: www.ibbr.umd.edu/events/visiting-ibbr.

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, sabina.mohan@nist.gov, 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:

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.
Identification of future medical standards efforts for new measurement areas that may not be currently addressed.
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. ( printed page 59113)
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.

Footnotes

1. `NHE Fact Sheet | CMS', n.d. < www.cms.gov/data-research/statistics-trends-and-reports/national-health-expenditure-data/nhe-fact-sheet > [accessed 16 August 2026].

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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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[FR Doc. 2026-19147 Filed 9-17-26; 8:45 am]

BILLING CODE 3510-13-P

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91 FR 59111

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“Request for Information (RFI) on Future Needs for Medical Metrology and Standards for Medical Imaging, Devices, Diagnostics and Therapy,” thefederalregister.org (September 18, 2026), https://thefederalregister.org/documents/2026-19147/request-for-information-rfi-on-future-needs-for-medical-metrology-and-standards-for-medical-imaging-devices-diagnostics-.