QAs

REQUEST FOR PROTOTYPE PROPOSALS (RPP)

Ultrasound Diagnostic System, Hand Carried (USHC)
Questions and Answers
(Additional Questions and Answers set is available as an attached Excel spreadsheet.)

4 November 2026

Responses to vendor questions:
1. The FDA has a requirement which prevents Medical Device Manufacturers from preselling devices which are not 510k cleared. Since you are requesting prototypes, are you looking for devices that are available as prototypes before 510K clearance? If so, is there a way we can comply with the FDA requirement and your request? Does DHA have any special exception in reference to the FDA requirement from preselling non-FDA cleared devices? Answer: The term “prototype” is used in this RPP to describe a commercial or nondevelopmental device that will be tested for military utility. The Government is not seeking a developmental device; we are seeking a fully mature, COTS or NDI device that is already FDA cleared.

2. Can you verify at what point the device would require FDA 510k submission and approval? Is this post delivery of the Prototype?
Answer: See response to Question #1.

3. Can you provide the Government’s expectation of the working order of the Prototype? Operational, 510k cleared, scanning, etc.?
Answer: See response to Question #1.

4. Does the cost of the Prototype include the development cost? Answer: See response to Question #1.

5. Can you provide the MIL-STD-810 requirements that will apply to this prototype and when the device will be tested? Is it required for the prototype to meet all of the MILSTD-810 requirements upon delivery? Answer: Refer to Section 5.2 – Additional Performance Attributes (APAs). APA #4 lists applicable MIL-STD-810H requirements but may not be all inclusive. Testing will be tailored and the specifics of what will be tested are unknown at this time.

6. Can the delivery date of the Prototype be extended? Can a future date be included in a vendor’s proposal?
Answer: The Government is seeking a technically mature COTS device. If future delivery is required, then the proposal must include substantial justification for consideration.

7. If modifications are required post award of the prototype how will this be addressed?
Answer: Modifications to meet the intent of the RPP should be addressed in the proposal, as this should be a COTS or NDI item that requires minimal to no modification. Any potential contract modifications will be conducted through the AO.

8. Do you require 3D/4D probes or just reconstruction of images?