Ophthalmic Adaptive Optics (AO) Retinal Imaging System

Closed Solicitation Posted

Solicitation number
RFQ-FDA-133666
Agency
Responses due
Set-aside
Total Small Business

Opportunity facts

Place of performance
Silver Spring, Maryland 20993, United States

Notice details come from SAM.gov. Updated .

About this opportunity

The Food and Drug Administration seeks one Ophthalmic Adaptive Optics retinal imaging system, with proposals due June 16 and questions due June 10. The procurement is a total small business set-aside under NAICS code 334510, Electromedical and Electrotherapeutic Apparatus Manufacturing, with a small business size standard of 1,250 employees.

Delivery and installation occur at the FDA White Oak Campus, 10903 New Hampshire Avenue, Building WO62, Room G101, Silver Spring, Maryland 20993, to support retinal imaging research, biomarker development, and regulatory science activities. The system must deliver pupillary reflectance imaging with non-contact transscleral flood illumination, lateral optical resolution of 2–3 micrometers in tissue, pixel pitch of 1 micrometer, and a cellular view field angle greater than 4 degrees by 4 degrees. Physical constraints are a maximum footprint of 65 cm by 65 cm by 65 cm and weight not exceeding 60 kg, with input voltage of 100–240V AC at 50–60 Hz and maximum power consumption of 450W. Delivery must be completed within 120 days of award during FDA White Oak Campus normal business hours, 8:00 AM to 3:30 PM.

Deliverables include the imaging system with all hardware and associated software with license keys, delivery and installation, operator training, user manuals, and a minimum one-year full warranty covering all components. Award is on a Lowest Price Technically Acceptable basis. Prior to award, the FDA Chief Information Officer must pre-approve all IT hardware and software-firmware. Offerors must submit technical and price quotations, warranty terms, UEI confirmation with active SAM.gov registration, lead time for delivery, and country of origin information. The PSC code is 6640, Laboratory Equipment and Supplies.

Notice text

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) intends to acquire one (1) Ophthalmic Adaptive Optics (AO) Retinal Imaging System. The system will be used to support retinal imaging research, biomarker development, and regulatory science activities at the FDA White Oak Campus in Silver Spring, Maryland. Delivery and installation shall be made to 10903 New Hampshire Avenue, Building WO62, Room G101, Silver Spring, MD 20993. For complete requirements, terms, and conditions, please refer to the attached Combined Synopsis/Solicitation (CSS) document No. RFQ-FDA-133666 .

Files

File Type Posted
RFQ-FDA-133666.docx DOCX document

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