Ophthalmic Adaptive Optics (AO) Retinal Imaging System
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The Food and Drug Administration (FDA), specifically the Center for Devices and Radiological Health (CDRH), Office of Science and Engineering Laboratories (OSEL), Division of Biomedical Physics (DBP), intends to acquire one Ophthalmic Adaptive Optics (AO) Retinal Imaging System. This system will support retinal imaging research, biomarker development, and regulatory science activities at the FDA White Oak Campus in Silver Spring, Maryland. This is a Combined Synopsis/Solicitation (RFQ-FDA-133666), set aside for Total Small Business concerns. Offers are due by June 16, 2026, at 2:00 PM ET.
Scope of Work
The requirement is for one (1) AO Retinal Imaging System, including hardware, software, delivery, installation, and operator training. Key system capabilities include:
- Pupillary reflectance imaging and non-contact transscleral flood illumination.
- Lateral optical resolution of 2–3 µm in tissue and a pixel pitch of 1 µm.
- Live cellular-level imaging view and analytic software for automatic quantification of cellular features.
- Physical specifications: Maximum footprint of 65 cm x 65 cm x 65 cm and maximum weight of 60 kg.
- Software features: Pupil alignment feedback, image comparison for follow-up examinations, and automatic image analysis.
- A minimum one (1) year full warranty after Government acceptance, covering all hardware and software.
- Deliverables include initial delivery and setup, user manuals, hardware/software with license keys, operator training, and proper packaging/marking.
- Vendors must obtain pre-approval from the FDA CIO for all IT hardware and software used.
Contract Details
- Type: Combined Synopsis/Solicitation (RFQ-FDA-133666)
- Set-Aside: Total Small Business Set-Aside (FAR 19.5)
- NAICS Code: 334510 — Electromedical and Electrotherapeutic Apparatus Manufacturing (Small Business Size Standard: 1,250 employees)
- Contract Line Items (CLINs): 0001 (AO Retinal Imaging System with 12 months warranty), 0002 (Delivery, Installation, and Setup), 0003 (Operator Training).
- Period of Performance: Delivery within 120 days of award, followed by a one-year warranty.
Submission & Evaluation
- Evaluation Basis: Lowest Price Technically Acceptable (LPTA). Offers must meet all salient characteristics to be considered technically acceptable.
- Questions Due: June 10, 2026, 10:00 AM EASTERN TIME.
- Offers Due: June 16, 2026, 2:00 PM EASTERN TIME.
- Submission Method: Email to the Contracting Officer and Contract Specialist listed in the SAM.gov posting.
- Required Submissions: Technical quotation (maximum 10 pages), price quotation, warranty terms, UEI and SAM.gov registration confirmation, lead time for delivery, and country of origin.
- Preferred File Format: Searchable PDF and Excel.
- Offer Acceptance Period: 120 calendar days from the date specified for receipt of offers.
Additional Notes
Offerors are responsible for monitoring SAM.gov for any amendments. All invoice submissions must be made electronically through the U.S. Department of Treasury's Invoice Processing Platform System (IPP).