When is the submission deadline?

Submissions are due August 31, 2026. Questions must be submitted by August 21, 2026.

It was issued by Food and Drug Administration. The work is located in Silver Spring, Maryland, United States.

Who is a good fit for this opportunity?

Expertise in computational modeling and simulation of transcranial ultrasound. Experience with regulatory science tools and medical device development. Knowledge of acoustic and thermal tissue properties. Background supporting clinical trial design and pre-market regulatory submissions. Capability to develop and disseminate software for researchers, device developers, and regulators.

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Regulatory Science Tool for Transcranial Ultrasound Modeling

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Overview

Data Analytics, AI & Cloud Hosting

Silver Spring, Maryland, United StatesPosted: August 15, 2026Deadline: August 31, 2026

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SUMMARY

This requirement seeks a computational modeling package for simulating transcranial ultrasound sonication protocols. The tool should support regulatory review, protocol comparison, consensus tissue-property use, and clinical trial design.

KEY REQUIREMENTS

Must be principal investigator or co-investigator on a minimum of two completed research projects involving TUS simulation within the past five years, or have made significant contributions to open-source TUS simulation tools.
Must have a minimum of three peer-reviewed journal articles on ultrasound propagation through heterogeneous biological media within the past fifteen years, with at least one addressing transcranial ultrasound applications.
Must have immediate access to and demonstrated proficiency with at least one TUS simulation platform and computational infrastructure capable of running full 3D patient-specific TUS simulations.
Must comply with all FDA security requirements for handling sensitive information.
Must be able to perform work at own facility.
Must be able to participate in bi-weekly virtual check-in meetings with FDA technical staff.

CONTRACT DURATION

12 months

TIMELINE

Questions due by August 21st, 2026.

Proposals due by August 31st, 2026.

Period of performance from September 15th, 2026 to September 14th, 2027.

QUESTION DEADLINE

August 21, 2026

CONTACTS

Primary procurement contact — name, title, email, and phone

Additional decision-makers and their departments

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Issuing Agency

Food and Drug Administration

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DESCRIPTION

The vendor will provide a regulatory science tool for transcranial ultrasound modeling. The work involves developing a computational modeling package capable of simulating transcranial ultrasound sonication protocols as a regulatory science tool for dissemination to medical device developers, researchers, and regulators.

The tool is intended to mitigate uncertainties caused by modeling variability and enable comparisons across different sonication protocols. It will also promote the use of consensus acoustic and thermal tissue properties across the research and development community, streamline clinical trial design, and support consistent review of pre-market submissions.

The contract period will be one year.

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Frequently asked questions

When is the submission deadline?: Submissions are due August 31, 2026. Questions must be submitted by August 21, 2026.
Who issued this RFP?: It was issued by Food and Drug Administration. The work is located in Silver Spring, Maryland, United States.
Who is a good fit for this opportunity?: Expertise in computational modeling and simulation of transcranial ultrasound
Experience with regulatory science tools and medical device development
Knowledge of acoustic and thermal tissue properties
Background supporting clinical trial design and pre-market regulatory submissions
Capability to develop and disseminate software for researchers, device developers, and regulators

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Settle pieces together buyer signals, budgets, contract activity, and the sources your team already monitors. See why an opportunity fits and what to do before the RFP posts.

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Regulatory Science Tool for Transcranial Ultrasound Modeling (Due August 31, 2026) | Settle RFP Hunter