W91CRB-RPP-USHC_QAs.pdf
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- Solicitation number
- W91CRB-RPP-USHC
About this file
This document is a Questions and Answers set for a Request for Prototype Proposals (RPP) issued by the Defense Health Agency (DHA) for an Ultrasound Diagnostic System, Hand Carried (USHC), dated 4 November 2026.
The Government seeks a fully mature, commercially available off-the-shelf (COTS) or non-developmental item (NDI) ultrasound device that is already FDA 510(k) cleared, not a developmental prototype. Vendors should address any necessary modifications in their proposals, as the device should require minimal to no modifications to meet the RPP intent. The procurement references Section 5.2 Additional Performance Attributes (APAs), with APA #4 listing applicable MIL-STD-810H requirements, though testing will be tailored with specifics determined at a later time. Regarding delivery schedules, if vendors propose a future delivery date beyond the standard timeline, substantial justification must be included for Government consideration; a maximum two-week extension from the original due date is acceptable. Vendors should include proposed costs for Risk Management Framework (RMF) documentation and submission in their proposals, with the RMF process expected to begin shortly after contract award and timeline details to be discussed at a kick-off meeting. The requirement for 3D/4D probes has been removed and is not required. Additional questions and answers are available in an attached Excel spreadsheet.
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Other files
| File | Type | Posted |
|---|---|---|
| W91CRB-RPP-USHC_QAs_Cont..xlsx | XLSX spreadsheet | |
| W91CRB-RPP-USHC_Rev 1.pdf | ||
| W91CRB-RPP-USHC_Final.pdf |
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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 pre-selling 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 pre-selling non-FDA cleared devices?
Answer: The term “prototype” is used in this RPP to describe a commercial or non-developmental 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.?
4. Does the cost of the Prototype include the development cost?
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 MIL- STD-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?
Answer: This specification has been removed from the RPP and is not required.
9. When will RMF Documentation/submission be required? How will the cost of RMF be addressed?
Answer: The vendor should suggest costs associated to conduct RMF.
Documentation and submission timeline will be discussed during a kick-off meeting. The RMF process is expected to be initiated shortly after award.
10. Request a three week extension of the due date from the date of the Question and Answer is posted by the contracting office.
Answer: The Government can accept up to a two-week extension.
**Please see additional questions and answers set on attached Excel spreadsheet. **
File details come from the government source that posted it. Updated .