Description
The U.S. Food and Drug Administration (FDA) is seeking an Adaptive Optics (AO) Retinal Imaging System to support multiple ongoing studies under the ophthalmic devices program charter. The system should have specific technical specifications, including a lateral resolution in tissue of 2-3 um, a pixel pitch of 1 um, and a focusing range in tissue of 300 um. The system should also have simultaneous live widefield overview and cellular-level imaging capabilities. The FDA requires the contractor to provide initial delivery and setup of the system, user manuals, training sessions, and warranty and technical support. The contract will include a 1-year warranty and require the contractor to comply with Section 508 standards.
Some key points to consider are:
• The system will be used to support the development of novel cellular imaging biomarkers and will serve as a foundational platform for creating new analytical methods and tools.
• The system should be compatible with versions currently used at FDA and should conform to 36 CFR Part 1194.41 and 36 CFR Part 1194.24.
• The contractor should provide a complete list of hardware and software that will be used to fulfill the contract, which will need to be approved by the FDA Chief Information Officer (CIO).
• The contract will require the contractor to deliver the system to the FDA's White Oak Campus in Silver Spring, MD.