Adaptive Optics (AO) Retinal Imaging System

Statement of Need / Procurement Request

This document outlines the need for a high-resolution Ophthalmic Adaptive Optics (AO) Retinal Imaging System for the FDA's Center for Devices and Radiological Health (CDRH), specifically the Office of Science and Engineering Laboratories (OSEL) and the Division of Biomedical Physics (DBP). The system will support ongoing studies focused on characterizing novel optical diagnostic devices for retinal diseases, developing biomarkers for early disease detection (e.g., glaucoma), and advancing regulatory science tools.

• Hardware:

  • Methodology: Pupillary reflectance imaging and non-contact transscleral flood illumination.
  • Light sources: Infrared LED and SLD (750 to 890 nm).
  • Lateral resolution in tissue (optical): 2-3 µm.
  • Pixel pitch: 1 µm.
  • Focusing range in tissue: 300 µm.
  • Cellular View image field angle: >6.5° x 6.5°.
  • Fundus Overview image field angle: 30° x 30°.
  • Minimum pupil diameter: 4 mm.
  • Refractive error adjustment: +15 D to -15 D, continuous.
  • Acquisition time: <3s.
  • Fixation targets: Internal and external.

• Software:

  • Simultaneous live widefield overview and cellular-level imaging.
  • Pupil alignment feedback.
  • Image comparison for follow-up examination.

• Electronic Interfaces and others:

  • Input voltage and frequency: 100-240 V, 50-60 Hz.
  • Power consumption (max): 450 W.
  • Dimensions (L x W x H): <= 65cm x 65cm x 65cm.
  • Weight: <= 60 kg.

• Contract Type: To Be Determined (TBD).

• Period of Performance: To Be Determined (TBD).

• Assembly and Delivery Requirements: Includes initial delivery and setup, user manuals, supply of all hardware and associated software with license keys, training sessions, and packaging/marking per Government specifications. Delivery hours are 8:00 AM to 3:30 PM.

• Warranty: A full 1-year warranty after delivery is required.

• Section 508 Standards: All Electronic and Information Technology (EIT) must comply with Section 508 of the Rehabilitation Act. A technical evaluation factor will specifically address Section 508 requirements, requiring submission of a Section 508 Product Assessment Template.

• IT Hardware/Software Pre-Approval: Prior to award, all IT hardware and/or software-firmware-freeware must receive pre-approval from the FDA Chief Information Officer (CIO). This requires a complete list of IT hardware (manufacture, nomenclature, model number) and software (manufacture, nomenclature, version number).

• Competition: Full and Open/Fair Opportunity.

• The document lists potential vendors: Imagine Eyes, Canon Inc., EarlySight, Physical Sciences Inc., and Robotrak Technologies Co., Ltd.

• Due to the requirement for installation, all items must be available from one contractor/vendor.

Sources Sought Notice

This notice is for market research purposes to identify qualified sources capable of providing an Adaptive Optics (AO) Retinal Imaging System for the U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), Office of Science and Engineering Laboratories (OSEL), Division of Biomedical Physics (DBP). The system will support ophthalmic research programs, including the development of regulatory science tools and standards for cellular-level ophthalmic imaging. This notice does not constitute a solicitation, and no contract will be awarded based on responses.

• A complete Adaptive Optics (AO) Retinal Imaging System (hardware, software, delivery, installation, training).

• Hardware Specifications: Pupillary reflectance imaging, IR LED and SLD light sources (750-890 nm), 2-3 µm lateral resolution, 1 µm pixel pitch, 300 µm focusing range, specific field angles (>6.5° x 6.5° cellular, 30° x 30° fundus), minimum 4 mm pupil diameter, +15 D to –15 D refractive error adjustment, <3 seconds acquisition time, internal/external fixation targets.

• Software Requirements: Simultaneous live widefield and cellular imaging, pupil alignment feedback, image comparison for follow-up.

• Physical Requirements: Max dimensions 65x65x65 cm, max weight 60 kg, 100-240V, 50-60 Hz, max 450W power consumption.

• Delivery, Installation, and Support: Must be provided by a single contractor, including delivery to FDA White Oak Campus, user manuals, license keys, operator training, packaging, shipping, a minimum one-year warranty, and an IT Hardware/Software list for CIO pre-approval.

• Response Deadline: May 12, 2026, at 4:00 PM Eastern Time.

• Submission Method: Electronically via email to freshta.javid@fda.hhs.gov.

• Subject Line: Sources Sought Response — AO Retinal Imaging System — CDRH-2026-133666

• Responses will be used for market research and acquisition planning only; they will not be evaluated competitively.

• Company Information (name, address, POC, CAGE, UEI, business size/status, country of incorporation/manufacture, GSA Schedule if applicable).

• Technical Capability (specific product meeting requirements, technical description, datasheets, prior government/academic deliveries).

• Delivery and Installation Capability (confirmation of ability to deliver, install, train at FDA White Oak; estimated lead time; single contractor confirmation).

• Small Business Subcontracting (if applicable for large businesses).

• Rough Order of Magnitude (ROM) Pricing (for the complete system).

• Section 508 Compliance posture and availability of Product Assessment Template.

• All IT Hardware/Software requires FDA CIO pre-approval prior to contract award.

• Compliance with Section 508 of the Rehabilitation Act is mandatory.

• Contractors must be registered in SAM.gov.

This is a Sources Sought Notice only for market research. It is not a solicitation, and no contract will be awarded. Respondents will not be reimbursed for costs incurred.