RFQ_75F40126Q00193.pdf

COMBINED SYNOPSIS/SOLICITATION

Request for Quote (RFQ) 75F40126Q00193

Center for Devices and Radiological Health (CDRH) Clinical Study Service Contract

75F40126Q00193

Table of Contents

Background Objectives Tasks Contractor Requirements Deliverables Inspection and Acceptance Period of Performance Place of Performance Contract Administration Government-Furnished Property (GFP) Security Considerations Travel Clauses and Provisions Evaluation Submission Instructions Attachment

COMBINED SYNOPSIS/SOLICITATION

CDRH Clinical Study Service Contract

This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with part 12. This announcement constitutes the only solicitation. Offers are being requested and a separate written solicitation will not be issued.

Solicitation number 75F40126Q00193 is issued as a request for quotation (RFQ) for CDRH Clinical Study Service Contract.

This solicitation incorporates provisions and clauses by reference. The full text of provisions and clauses may be accessed electronically at www.acquisition.gov. The solicitation document and incorporated provisions and clauses are those in effect through the Federal Acquisition Circular

(FAC 2026-01).

• NAICS Code: 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

• PSC Code: R425

• Type of Contract: Firm Fixed Price (FFP)

• Acquisition Method: FAR Part 12– Acquisition of Commercial Products and Commercial

Services

Statement of Work

Background

Electrocardiography (ECG) is a noninvasive method for recording the heart's electrical activity using skin electrodes. It is among the most widely used diagnostic tools in medicine because it provides real-time information about cardiac function, including heart rhythm (normal versus arrhythmias), conduction abnormalities, ischemia and infarction, and electrolyte disturbances.

The informative nature and widespread adoption of ECG technology in the standard of care have made ECG signals a popular input for a wide array of AI/ML-enabled medical devices. While our team is currently developing a novel computational/benchtop framework to standardize ECG signals across different hardware platforms, the framework's real-world clinical and regulatory utility cannot be fully realized without rigorous clinical validation. AI/ML medical device regulations (e.g., 21 CFR 870.2200 and 21 CFR 870.2380) mandate validation on data representative of the intended use population. This service contract addresses the final translational gap by clinically validating our developed framework using real-world clinical data with a gold standard comparator, thereby paving the way for its adoption as a Regulatory Science

Tool (RST). Additionally, the clinical data collected in this project will independently serve as a gold standard validation dataset and comparator for similar algorithms and frameworks developed in the future.

This service contract directly supports CDRH's strategic priority to advance health equity and streamline regulatory evaluation. By validating a tool that allows existing public datasets to be used for a wider range of devices, we can reduce the need for costly, duplicative clinical studies.

This is particularly impactful for validating devices intended for underrepresented demographic or clinical subgroups, where new data collection is a significant barrier. This is a new procurement to facilitate clinical data collection for the regulatory validation framework of a wide range of new and emerging artificial intelligence (AI) and machine learning (ML)-enabled ECG devices. The Agency needs to procure this service because high-quality clinical data is required during the regulatory review of marketing applications for such devices to ensure patient and public safety. However, current approaches to acquiring new clinical data for each of these devices are time-consuming and sometimes cost-prohibitive, especially for small businesses.

The successful completion of this service contract would yield a clinically validated Regulatory Science Tool that would provide a least-burdensome approach for clinical validation of such medical devices. Using the results obtained from the research supported by this procurement, sponsors would be able to leverage existing retrospective datasets to support their claims of safety and efficacy during marketing applications, which would enable public access to new and safe medical technologies while also reducing the burden for FDA medical device reviewers at

OHTII.

Objectives

The primary goal of this 1-year contract is to clinically validate our in-house ECG signal transformation framework. Success will enable the use of vast, diverse public ECG datasets for the regulatory evaluation of AI/ML-enabled cardiovascular devices.

Key Milestones & Deliverables:

• Q1: The contractor prepares the clinical study protocol in collaboration with FDA and secures Institutional Review Board (IRB) approval for the clinical protocol to be executed.

• Q2-Q3: Under the contract, the contractor collects all prospective clinical data and performs AI/ML-based signal analysis of the data.

• Q3: Under the contract, the contractor finishes synthesis of wearable ECG signals based on retrospective data using the AI/ML methods developed by the FDA.

• Q3-Q4: Under contract, the contractor curates the retrospective and prospective datasets for FDA review to be publicly disseminated.

Tasks

The contractor must execute a prospective clinical study to collect, annotate, and deliver concurrent recordings of ECG signal datasets according to the following specifications, in addition to a retrospective paired synthetic ECG dataset:

1. Prospective Study:

1.1. Subject Recruitment and Characteristics in Prospective Clinical Study:

The contractor must recruit 150 subjects in the base year, and subsequently 35 subjects in each option year of the contract, who are prescribed a suitable non-ECG diagnostic test relevant as ground truth and ECG acquisition as part of their clinical care.

1.1.1 Ground Truth:

Subjects must have received or be scheduled to receive a suitable non-ECG diagnostic test (imaging/echocardiography/catheterization - to be determined) relevant as ground truth as part of routine clinical care within a predetermined and agreed-upon time window. Subjects must not have received treatments corresponding to the ground truth that would affect the conditions for which ground truth was collected prior to the collection of the ECG signals.

1.1.2 Exclusion Criteria:

o Individuals 21 years of age or younger;

o Individuals with wounds, burns, or amputations that would prohibit traditional 12-lead patch-based ECG collection.

o Individuals with pacemakers;

o Pregnant individuals;

o Individuals for whom a physician has determined that participation in the study would cause unnecessary risks (e.g., individuals allergic to ECG electrodes, individuals for whom participation in the study would result in delay or disruption of therapy, etc.).

1.1.3. Demographics:

The cohort must be equally split between male and female subjects (50% ± 4% must be male) adults. The age distribution of the cohort must be 25% ± 4% between 22 and 44 years, 41% ± 4% between 45 and 64 years, and 34% ± 4% aged 65 years and older. The cohort's racial composition must be representative of the U.S. population or be enriched for relevant sub-demographics (up to 40% for each non-majority group; no enrichment is requested for mixed groups and other groups with less than 5% prevalence). The cohort must include no more than 17% of its composition from subjects with a history of substance use disorder.

1.1.4. Metadata Collection:

For each subject, the contractor must collect and record the following metadata as part of the electronic health record:

o Reason for prescription of ECG recording o Height and weight o Race o Ethnicity o History of arrhythmias or cardiovascular disease o Known health conditions o History of substance use disorder.

o Technical characteristics of the recording characteristics (for both “test” and

“reference”), including resolution, filter settings, ECG device serial numbers.

o Non-ECG ground truth collected within a pre-specified time from the ECG.

o Patient history data supporting that no significant therapy or event relevant for the condition of interest occurred between the non-ECG ground truth collected and the ECG recording.

1.2. Data Collection Protocol:

The contractor must conduct at least one data-collection session for each subject. Each session must include the concurrent and synchronized recording of two ECG signals from an FDA approved 12-lead ECG device (reference) and a different make or model FDA approved 12-lead ECG device (test). ECG must be collected from standard electrode locations using FDA approved, good quality, commercial disposable “wet” electrodes with the patient in resting conditions. A healthcare provider responsible for the ECG acquisition must verify (visually and using the signal-quality indication from the ECG devices, if available) that both test and reference ECG appear of acceptable quality and troubleshoot as appropriate to ensure that ECGs of acceptable quality are collected. If ECGs of adequate quality cannot be acquired within 5 tries, the patient must be excluded. "Reference” and “Test” ECG devices must be of different make and models (multiple “reference” and “test” devices may be used, as long as they are of the same make and models respectively, however all devices used must be tracked and retained as they need to be individually characterized – see note below), The contractor must collect the signals when subjects are in the supine position and do not move during signal collection.

FDA must agree to the protocol prior to finalization of the protocol.

NOTE: the contractor must allow FDA to perform bench testing to characterize the devices used for data collection on-site either by FDA personnel or by the Contractor clinical engineering team, at contractor’s preference.

NOTE: at the sole discretion to the sponsor and care clinicians, the “reference” ECG collected may be used as part of clinical care. The care clinician must not be blinded to the test and reference ECG.

1.3. Institutional Review Board (IRB):

The contractor must prepare and seek IRB approval for the clinical study to be executed.

2. Retrospective Paired Synthetic ECG Dataset:

The contractor must prepare a retrospective dataset of at least 4,000 subjects with characteristics similar to those of the prospective data with metadata information that includes the items listed in Section 1.1.4, real 12-lead patched ECG data, and corresponding synthetic ECG data based on algorithms developed at FDA. All signal processing and transformations using FDA-developed algorithms will be performed at the contractor’s institution on retrospective data collected at the contractor's affiliated medical facility.

FDA must agree to data collection protocol prior to finalizing.

3. Data Annotation and Availability:

The contractor must ensure the final prospective dataset contains all recorded ECG signals, and for each signal, fully reflects the ground truth data, with all demographic data and all clinical annotations (e.g., the subject was in sinus rhythm or undergoing arrhythmia). The complete, de-identified dataset must be prepared for public dissemination.

Contractor Requirements

The contractor must have a demonstrated history of the following:

a. Established ability to collaborate with federal institutions such as NIH or NSF and published journal articles in prestigious journals over the last five years

b. Successfully conducted at least five clinical studies on healthy and unhealthy subjects

c. Affiliation with a hospital in close proximity (< 10 miles)

d. Established history of working in the field of artificial intelligence and machine learning for > 10 years

e. Extensive history of working in the analysis of wearable datasets for > 10 years

Deliverables

Table 1: Deliverable Schedule Deliverable Format Due Date Recipient

Kickoff Virtual Held within 20 days after award date order. COR

A Project Management Plan: A plan outlining the project timeline, milestones, and risk management strategies

Microsoft Within 30 days of contract award COR

Clinical study protocol for FDA review

Microsoft Within 30 days of contract award COR

Secure IRB approval for the clinical study plan after incorporating FDA feedback

Microsoft Within three months of the contract award COR

Curated retrospective dataset of 12-lead ECG signals

Microsoft Within six months of the award COR

Finalize all data collection activities

Microsoft Within nine months of the award COR

Generated synthetic wearable signal dataset based on the 12-lead ECG signals

Microsoft Within nine months of the award COR

Reports on the generation of synthetic signals progress

Microsoft Monthly COR

Reports on enrollment, progress, and any deviations from the study protocol

Microsoft Monthly COR

A prospective dataset of fully de-identified concurrent 12-lead ECG and wearable ECG signals

Microsoft Within one year of the award COR

A retrospective dataset of fully de-identified concurrent real 12-lead ECG and synthetic wearable ECG signals. Both de-identified datasets must include all corresponding annotations, physiological signals, and metadata

Microsoft Must be provided to FDA for review within the first year and publicly disseminated no later than one year after completion of the base year of the contract

COR

A Complete Clinical Study Report: A final report detailing the study methodology, subject demographics, data collection procedures, and a summary of the collected data

Soft copy in PDF format

Within one year of the contract award COR

Fully Annotated and De-identified Prospective Datasets: The complete, de-identified datasets for the prospective data containing all collected physiological signals and metadata.

Standard, non-proprietary formats (e.g., CSV, HDF5) via a secure digital transfer method

Within one year of the contract award COR

Analysis Report on the Retrospective Dataset: the contractor must work closely with FDA to carry out testing hypothesis for the retrospective dataset. The full analysis report of

Microsoft Within one year of the contract award COR

Inspection and Acceptance

Inspection and acceptance of the services to be performed under this purchase order must be performed at the destination by the Contracting Officer's Representative (COR).

The Government reserves the right to inspect all services called for by this purchase order in the manner and at times and places as determined by the Contracting Officer. The Contractor must provide, without additional charge, all reasonable facilities and assistance for the safe and convenient inspection of services performed.

Services will be accepted upon determination that they conform to the requirements specified in this purchase order. Acceptance must be evidenced by the signature of the authorized Government representative on the applicable receiving report, invoice, or other documentation as designated by the Contracting Officer.

If any services are found to be deficient or nonconforming, the Contractor must, at no additional cost to the Government, promptly re-perform or correct the deficient services within a timeframe specified by the Contracting Officer.

Period of Performance

Base Year: September 30, 2026 through September 29, 2027 Option Year I: September 30, 2027 through September 29, 2028 Option Year II: September 30, 2028 through September 29, 2029 Option Year III: September 30, 2029 through September 29, 2030 Option Year IV: September 30, 2030 through September 29, 2031 the performance analysis on the retrospective dataset will be prepared for release to the public.

This analysis plan must be discussed with FDA and agreed upon before commencement of the analysis Curated prospective and retrospective datasets, alongside a comprehensive report of the clinical study and all project-relevant activities, to FDA for review and eventual public dissemination of the datasets

Microsoft Within one year of the award COR

After completion of the report, the contractor will work collaboratively with FDA to write a journal manuscript to publish the dataset.

Microsoft COR

• Base Year: The primary data collection, annotation, and delivery of the clinical study and dataset as outlined in the Statement of Work (SOW) must be completed within the base year period.

• Option Years: These optional years may be exercised in increments of one year at the government's discretion for additional ECG data collection, concentrating on individuals with conditions that were determined to require supplemental data collection based on the analysis performed on the data collected from prior years of the contract. The contractor must work with the FDA and seek FDA's agreement to finalize the enrollment requirements for each option year.

In each option year, the contractor must continue enrolling in additional subjects until they have successfully collected concurrent ECG data as required by the FDA approved protocol for 35 subjects in that option year. The data collected in each option year must be prepared for public release at most one year after the completion of that option year.

Place of Performance

All work can be performed remotely at the contractor's facilities. No on-site work at a government facility is required.

Contract Administration

Contracting Officer (CO): TBD Contracting Officer's Representative (COR): TBD Contract Specialist (CS): TBD

Contracting Officer’s Authority

The Contracting Officer (CO) is the only person authorized to approve changes in any of the requirements of this contract. In the event the Contractor effects any changes to this contract at the direction of any person other than the CO, the changes will be considered to have been made without authority, and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof. The CO is the only Government Official authorized to change term or condition of the contract. The Contracting Officer is the only individual who can legally obligate Government funds.

Government-Furnished Property (GFP)

Not Applicable

Security Considerations

None

Travel

Not Applicable

Clauses and Provisions

Federal Acquisition Regulation (FAR) Clauses and Provisions

52.212-4 Terms and Conditions—Commercial Products and Commercial Services (Nov 2025)

(DEVIATION)

52.203-17 Contractor Employee Whistleblower Rights (Nov 2023) 52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) 52.204-13 System for Award Management-Maintenance (Nov 2025) (DEVIATION) 52.209-6 Protecting the Government's Interest When Subcontracting With Contractors Debarred, Suspended, Proposed for Debarment, or Voluntarily Excluded (Nov 2025) (DEVIATION) 52.209-10 Prohibition on Contracting with Inverted Domestic Corporations (Nov 2025)

(DEVIATION)

52.222-3 Convict Labor (Jun 2003) 52.222-19 Child Labor—Cooperation with Authorities and Remedies (Nov 2025) (DEVIATION) 52.222-35 Equal Opportunity for Veterans (Nov 2025) (DEVIATION) 52.222-36 Equal Opportunity for Workers with Disabilities (Nov 2025) (DEVIATION) 52.222-37 Employment Reports on Veterans (Nov 2025) (DEVIATION) 52.222-41 Service Contract Labor Standards (Aug 2018) 52.222-42 Statement of Equivalent Rates for Federal Hires (May 2014) 52.222-43 Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) (Aug 2018) 52.222-50 Combating Trafficking in Persons (Nov 2025) (DEVIATION) 52.222-54 Employment Eligibility Verification (Nov 2025) (DEVIATION) 52.222-62 Paid Sick Leave Under Executive Order 13706 (Jan 2022) 52.224-3 Privacy Training (Jan 2017) 52.226-8 Encouraging Contractor Policies to Ban Text Messaging While Driving (May 2024) 52.232-33 Payment by Electronic Funds Transfer-System for Award Management (Oct 2018) 52.232-39 Unenforceability of Unauthorized Obligations (Jun 2013) 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Mar 2023) 52.233-3 Protest After Award (Nov 2025) (DEVIATION) 52.233-4 Applicable Law for Breach of Contract Claim (Nov 2025) (DEVIATION) 52.240-91 Security Prohibitions and Exclusions (Nov 2025) (DEVIATION) 52.240-92 Security Requirements (Nov 2025) 52.240-93 Basic Safeguarding of Covered Contractor Information Systems (Nov 2025) 52.217-9 Option to Extend the Term of the Contract (Mar 2000) The Government may extend the term of this contract by written notice to the Contractor any time before the contract expires; provided that the Government The total duration of this contract, including the exercise of any options under this clause, must not exceed the identified period of performance, inclusive of any options if exercised. Gives the Contractor a preliminary written notice of its intent to extend any time before the contract expires. The preliminary notice does not commit the Government to an extension. If the Government exercises this option, the extended contract must be considered to include this option clause.

52.212-1 Instructions to Offerors — Commercial Products and Commercial Services (Nov 2025)

(DEVIATION)

52.212-2 Evaluation — Commercial Products and Commercial Services (Nov 2025) (DEVIATION)52.203-11 Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions (Sep 2024) 52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements-Representation (Jan 2017) 52.204-7 System for Award Management (Nov 2025) (DEVIATION) 52.217-5 Evaluation of Options (Nov 2025) (DEVIATION) 52.225-25 Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran—Representation and Certifications JUN 2020 52.240-90 Security Prohibitions and Exclusions Representations and Certifications (Nov 2025)

(DEVIATION

Health and Human Services Acquisition Regulation (HHSAR) Clauses

352.224-70 Notification of System of Records Notice (Feb 2024) (DEVIATION) 352.224-71 Confidential Information (Feb 2024) (DEVIATION) 352.227-70 Publications and Publicity (Dec 2015) 352.237-75 Key Personnel (Dec 2015) 352.232-71 Electronic submission of payment requests (FEB 2022)

(a) Definitions. As used in this clause - Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor must submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor must include a copy of the Contracting Officer's written authorization with each payment request.

(End of Clause)

FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (Jan 2022)

a. All Invoice submissions for goods and or services must be made electronically through the U.S. Department of Treasury’s Invoice Processing Platform System (IPP).

http://www.ipp.gov/vendors/index.htm

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract, or the clause FAR 52.212-4 Contract Terms and Conditions - Commercial Items included in commercial items contracts.

The IPP website address is: https://www.ipp.gov.

c. 1. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 - 5 business days of the contract award for new contracts or date of modification for existing contracts.

2. Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

3. The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

4. If your company is already registered to use IPP, you will not be required to re-register.

5. If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

d. Invoices that include time and materials or labor hours Line Items must include supporting documentation to

(1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable).

e. Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts. At a minimum the following cost information must be included, in addition to supporting documentation to substantiate costs incurred:

• Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

• Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)-show rate, base and total amount;

• Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;

• Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs must also be listed;

• Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor;

• Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and

• Fee - amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

f. Contractor is required to attach an invoice log addendum to each invoice which must include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) list of all invoices submitted to date under the subject award, including the following:

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

(b) total amount of all payments received to date under the subject contract or order

(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

g. Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments must be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

h. If the services are rejected for failure to conform to the technical requirements of the task order, or any other contractually legitimate reason, the Contractor must not be paid, or must be paid an amount negotiated by the CO.

i. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

j. The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

k. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827- ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

Evaluation

The Government will award a contract resulting from this solicitation to the responsible Offeror whose offer conforming to the solicitation will be most advantageous to the Government. The following will be used to evaluate offers:

Contractor Requirements

The contractor must have a demonstrated history of the following:

a. Established ability to collaborate with federal institutions such as NIH or NSF and published journal articles in prestigious journals over the last five years

b. Successfully conducted at least five clinical studies on healthy and unhealthy subjects

c. Affiliation with a hospital in close proximity (< 10 miles)

d. Established history of working in the field of artificial intelligence and machine learning for > 10 years

e. Extensive history of working in the analysis of wearable datasets for > 10 years

The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. The evaluation of options does not obligate the Government to exercise the option(s).

A written notice of award or acceptance of an offer furnished to the successful Offeror within the time for acceptance specified in the offer, must result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

All responsible sources may submit a quotation, which will be considered by the agency.

Submission Instructions

The Offeror’s quote must consist of a Cover Letter, and two (2) separate volumes:

• Cover Letter/Executive Summary

• Volume 1-Technical Approach

Volume 1 must indicate the Offeror’s capabilities and the means used to satisfy the requirements stated in the Statement of Work. The Offeror is encouraged to propose any innovative solutions that meet the performance requirements for this procurement. Please include the resumes (if available) for Contractor Personnel in this volume.

• Volume 2 -Price.

The Offeror must provide a quote that reflects their proposed solution to the Government’s requirements.

Line-Item Structure- See attached Price Sheet

Please submit any questions/clarifications regarding this requirement to Natalie.Brown@fda.hhs.gov, as soon as possible.

The Offeror’s quote must be submitted to Natalie.Brown@fda.hhs.gov no later than 28 July 2026, 2:00pm. Eastern Time.

The subject line must read: RFQ 75F40126Q00193 CDRH Clinical Study Service Contract

Attachment

Attachment A-Price Sheet RFQ 75F40126Q00193