Sources_Sought_Notice.docx

U.S. FOOD AND DRUG ADMINISTRATION

Center for Devices and Radiological Health (CDRH) Office of Science and Engineering Laboratories (OSEL)

SOURCES SOUGHT NOTICE

Adaptive Optics (AO) Retinal Imaging System

THIS IS A SOURCES SOUGHT NOTICE ONLY. This notice does not constitute a Request for Proposal (RFP), Request for Quotation (RFQ), or any other solicitation. The Government is not seeking proposals or quotations at this time and will not award a contract based on responses to this notice. Responses will be used solely for market research and acquisition planning purposes. The Government will not reimburse respondents for any costs incurred in preparing a response to this notice.

1. PURPOSE

The Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), Office of Science and Engineering Laboratories (OSEL), Division of Biomedical Physics (DBP) is issuing this Sources Sought Notice to identify qualified sources capable of providing an Adaptive Optics (AO) Retinal Imaging System in support of ongoing ophthalmic research programs.

The FDA is conducting market research in accordance with FAR Part 10 to determine the availability and capability of potential sources, identify small business participation opportunities, and establish the appropriate acquisition strategy. Responses to this notice will inform the Government's acquisition planning and will not be used in a competitive evaluation.

2. BACKGROUND

The FDA/CDRH/OSEL/DBP requires a high-resolution ophthalmic Adaptive Optics (AO) Retinal Imaging System to be deployed in the Optical Diagnostic Devices Laboratory at the FDA White Oak Campus, Silver Spring, Maryland. The system will support multiple ongoing studies under the ophthalmic devices program charter, including:

1. Development of AO biomarkers to advance regulatory science tools (RSTs) for ophthalmic medical devices

1. Retinal phantom development to establish testing standards for cellular-level ophthalmic imaging

1. Collaborative research with the National Eye Institute (NEI), University of Maryland Baltimore, and Johns Hopkins University Wilmer Eye Institute This acquisition directly supports FDA's mission to evaluate and validate emerging retinal imaging technologies and develop regulatory science tools and standards for cellular-level ophthalmic imaging.

3. DESCRIPTION OF REQUIREMENT

The Government requires an Adaptive Optics (AO) Retinal Imaging System (including all hardware, software, delivery, installation, and operator training) meeting the following salient characteristics. All items must be provided by a single contractor/vendor.

3.1 Hardware — Technical Specifications

3.2 Software Requirements

3.3 Electronic Interface and Physical Requirements

3.4 Delivery, Installation, and Support Requirements

The contractor shall provide all of the following as part of the requirement:

1. Initial delivery and setup/installation of the complete system at the FDA White Oak Campus

1. All user manuals and documentation

1. All hardware and associated software with appropriate license keys, expiration dates, and proof of entitlement certificates

1. Operator training sessions provided by the contractor at time of delivery/installation

1. Packaging, marking, and shipping in accordance with Government specifications

1. A minimum one (1) year full warranty after delivery

1. A complete IT Hardware/Software list (manufacturer, nomenclature, model/version number) to support required FDA Chief Information Officer (CIO) pre-approval prior to contract award Note: All deliveries must be made during normal FDA White Oak Campus delivery hours: 8:00 AM to 3:30 PM. Contractor must contact the Program Manager to schedule delivery.

4. REQUESTED INFORMATION

Interested firms are requested to submit a written response addressing ALL of the following items. Responses that do not address all items may not be considered. Responses should be concise — a maximum of eight (8) pages is recommended.

4.1 Company Information

1. Company name, address, point of contact, telephone number, and email address

1. CAGE Code and Unique Entity Identifier (UEI)

1. Business size and socioeconomic status under NAICS 334510 (e.g., Large Business, Small Business, Woman-Owned Small Business, Service-Disabled Veteran-Owned Small Business, 8(a), HUBZone)

1. Country of incorporation and country of manufacture for the proposed product

1. GSA Federal Supply Schedule contract number, if applicable

4.2 Technical Capability

1. Identify the specific product (manufacturer name, product name, and model number) that meets or most closely meets the salient characteristics described in Section 3

1. Provide a brief technical description of how your product meets each salient characteristic. If your product does not meet a specific characteristic, please describe any deviation

1. Provide product datasheets, brochures, or specifications sheets as attachments

1. Describe any prior delivery of this system or comparable ophthalmic AO imaging systems to Federal Government agencies or academic/research institutions

4.3 Delivery and Installation Capability

1. Confirm your firm's ability to deliver, install, and provide training at the FDA White Oak Campus, Silver Spring, MD

1. Provide an estimated lead time from order placement to delivery and installation

1. Confirm ability to provide all items from a single contractor/vendor with no third-party distributors for installation

4.4 Small Business Subcontracting

1. If your firm is a large business, describe any small business subcontracting opportunities associated with this requirement

4.5 Rough Order of Magnitude (ROM) Pricing

1. Provide a non-binding ROM price estimate for the complete system including hardware, software, delivery, installation, training, and one-year warranty

1. If your firm holds a GSA Schedule, provide the applicable Schedule price Note: ROM pricing is requested for market research and budget planning purposes only. It will not be used in any competitive evaluation.

4.6 Section 508 Compliance

1. Describe the Section 508 compliance posture of the system's software and digital interfaces

1. Indicate whether a Section 508 Product Assessment Template is available for the proposed product

5. SUBMISSION INSTRUCTIONS

Interested firms shall submit responses electronically via email no later than:

May 12, 2026 at 4:00 PM Eastern Time Responses shall be submitted to:

Contract Specialist: Freshta Javid Email: freshta.javid@fda.hhs.gov Subject Line: Sources Sought Response — AO Retinal Imaging System — CDRH-2026-133666 Responses may be submitted in Microsoft Word or Adobe PDF format. Proprietary information, if any, should be clearly marked. The Government will protect proprietary information from disclosure to the extent permitted by law.

Questions regarding this notice may be directed to Freshta Javid at freshta.javid@fda.hhs.gov. All questions and responses will be handled via email only. No telephone inquiries will be accepted.

6. ADDITIONAL REQUIREMENTS

6.1 IT Hardware and Software Pre-Approval

Prior to contract award, FDA policy requires pre-approval of all IT Hardware and/or Software-Firmware-Freeware from the FDA Chief Information Officer (CIO). For IT Hardware, this includes any device that processes or stores data or is controlled by data (e.g., computers, data switches), but does not include passive hardware (racks, network cables, power supplies/cords). The applicable contractor will be required to provide a complete list of Hardware and/or Software-Firmware-Freeware, including: IT Hardware — Manufacturer, Nomenclature, and Model Number; Software (all types) — Manufacturer, Nomenclature, and Version Number. Items rejected by the CIO will need to be replaced, and replacement items will require the same approval process.

6.2 Section 508 Standards

Electronic and Information Technology (EIT) developed, procured, or maintained for use by federal agencies must comply with Section 508 of the Rehabilitation Act (29 U.S.C. 794d) and the standards at 36 CFR Part 1194. A Section 508 Product Assessment Template will be required from the awardee prior to contract award.

6.3 Registration Requirement

All contractors doing business with the Federal Government must be registered in the System for Award Management (SAM) at www.sam.gov. Firms responding to this notice are encouraged to ensure their SAM registration is current and active.

7. DISCLAIMER

This Sources Sought Notice is issued solely for informational and market research purposes. It does not constitute a solicitation for proposals or quotations, nor does it represent a commitment by the Government to issue a solicitation or award a contract. No award will be made based on responses to this notice. The Government reserves the right to cancel this notice at any time and is not liable for any costs incurred by respondents in preparing a response.

The Government does not intend to rank, evaluate, or select sources based on responses to this notice. Responses will be used to determine acquisition strategy and will not be evaluated competitively. Firms that do not respond to this notice are not precluded from responding to any future solicitation.

— END OF SOURCES SOUGHT NOTICE —

Notice Number: CDRH-2026-133666 | NAICS: 334510 | Issued: May 5, 2026