RFI Amendment - W911SR-26-R-MNGS - Vendor Questions and Answers.docx

RFI# W911SR-26-R-MNGS

Amendment – Questions & Answers 15 May 2026

1. Is this the same opportunity that was put out by the MCDC Consortium?

Yes. This is the same RFI as was listed by the MCDC Consortium, however, all submissions should be made in accordance with this RFI.

2. How is “field deployment” defined in this context? Does it include environments such as field hospitals or triage settings, military vessels at sea, aircraft in flight, or remote operations conducted by small teams without access to trained medical personnel, electricity, or internet connectivity?

Deployed for use would mean anywhere from Rol 1-Rol 4 environments

3. Would pathogen enrichment strategies be considered acceptable as an alternative to host nucleic acid depletion?

Have to ensure process works and reliably detects and identifies a range of pathogens (e.g. in blood) at low clinically relevant concentrations.

4. While “offline bioinformatics and secure database management” are specified, is there an expectation for data transfer between field-deployed systems and a central or headquarters location?

At times may be needed for database updates.

5. With respect to “clinical decision support,” is the intent for military personnel to be directly involved in data analysis and decision-making, or is reliance on external subject matter experts anticipated?

As streamlined as possible, minimizing subjective interpretation. A physician is likely to be involved at some point as a patient is involved. Final output would meet FDA requirements that system can make a clinically relevant, and clinical actionable decision.

6. The description suggests use in non-clinical or non-hospital settings and does not specify therapeutic intervention. In this context, what type of regulatory strategy toward FDA authorization is envisioned for a ruggedized, field-deployable pathogen detection system?

Likely FDA De Novo approval for a regulated clinical diagnostic to make clinical decisions tied to that patient, not just pathogen detection or biosurveillance.

7. Is compliance with current Good Manufacturing Practices (cGMP) required for this effort?

cGMP and QMS is required. Management, design, record controls, supply chain, production/manufacture of device needs to meet specifications and FDA compliance for a medical diagnostic device, basically meets 21 CFR 820 and ISO 13485.