Ophthalmic Adaptive Optics (AO) Retinal Imaging System

The U.S. Food and Drug Administration’s Center for Devices and Radiological Health, through the Office of Science and Engineering Laboratories and the Division of Biomedical Physics, is seeking to procure a single Ophthalmic Adaptive Optics (AO) Retinal Imaging System for deployment at its White Oak Campus in Silver Spring, Maryland. The system must deliver cellular-level retinal imaging with specific performance criteria including a lateral optical resolution of 2–3 micrometers in tissue and a pixel pitch of 1 micrometer, enabling pupillary reflectance imaging, non-contact transscleral flood illumination, and live cellular imaging. The procurement includes delivery, installation, and setup at Building WO62, Room G101, along with operator training and a minimum one-year full warranty commencing upon government acceptance. The solicitation, designated RFQ-FDA-133666, is a total small business set-aside under NAICS code 334510, restricting eligibility to small businesses with no more than 1,250 employees. All offerors must be actively registered in SAM.gov and provide their Unique Entity ID, along with certifications regarding tax compliance, trafficking in persons, Buy American compliance, and trade agreements. Proposals must be submitted via email in searchable PDF or Excel format, limited to 10 pages, and must include technical and price quotations, warranty terms, lead time, and country of origin for all components. The acquisition follows a Lowest Price Technically Acceptable (LPTA) selection process, where proposals that fail to meet all salient characteristics are deemed technically unacceptable regardless of price. The winning offer must deliver the system within 120 days of award and comply with stringent invoicing requirements through the Treasury’s Invoice Processing Platform (IPP), including the submission of an invoice log addendum for every payment request. Payment is contingent upon government acceptance of the deliverables in new, usable, and acceptable condition, and will not be made if services or products fail to conform to technical requirements or are affected by events beyond FDA control. Contractors must adhere to federal regulations including the Contractor Code of Business Ethics, safeguarding of information systems, equal opportunity for veterans, employment eligibility verification, and the prohibition of convict labor and child labor. Special clauses include the Buy American Act with Alternate I, Trade Agreements, nonmanufacturer rule, limitations on subcontracting, and policies addressing DEI discrimination and combatting trafficking in persons. All communications, amendments, and updates will be posted on SAM.gov,