S05_RFI Vendor FAQs_FY26 ETMPM-TENS Procurement Program_Final_Issued 24AUG2026.pdf

Department of Veterans Affairs FY26 Recompete ETMPM & TENS Procurement Program

Consolidated Request for Information (RFI) Frequently Asked Questions (FAQs)

Purpose. The purpose of this document is to formally issue the consolidated RFI Frequently Asked Questions (FAQs) and the Government’s official responses. These clarifications support uniform, transparent, and acquisition-compliant communication with industry during market research and presolicitation activities for the FY26 ETMPM– TENS Procurement Program, consistent with FAR 15.201(e)—they do not constitute Government direction, establish evaluation criteria, or represent binding commitments.

Final requirements will be published exclusively in the formal solicitation on SAM.gov.

Executive Summary. This FAQ consolidates and standardizes questions submitted in response to RFI notices issued on January 20, 2026 and June 25, 2026. Each unique question appears once, even if multiple respondents asked similar questions.

Responses are high-level clarifications intended solely to support market research and requirement refinement. Binding requirements will be defined in the solicitation.

Q1. Will the VA set aside this procurement for SDVOSB/VOSB under 38 U.S.C. §8127 (Veterans First) and how will tiered evaluation work?

Government Response: Yes. The VA will issue this procurement as a Total SDVOSB set-aside and apply a tiered evaluation consistent with VAAR 819.7010 (SDVOSB first;

VOSB second; 8(a)/HUBZone third; then other than small businesses). This approach is supported by market research under NAICS 334510 and the SBA Nonmanufacturer Rule class waiver, enabling authorized small-business distributors to compete at the CLIN/SLIN level. Detailed tiering instructions will be specified in the solicitation.

Q2. May SDVOSB authorized distributors respond even if they are not OEM manufacturers?

Government Response: Yes. SDVOSBs (and other small businesses in lower tiers, if reached) may participate as authorized distributors under the SBA Nonmanufacturer Rule class waiver for NAICS 334510. Authorized distributor letters will be required in proposals.

Q3. Will OEM–distributor teaming arrangements be allowed?

Government Response: Yes. Teaming arrangements are permissible. Prime Offerors must meet responsibility requirements in FAR 9.104 and ensure proposed products meet all CLIN/SLIN Minimum Technical Requirements (MTRs). Limitations on subcontracting and certification requirements will apply per VAAR clauses.

Q4. Will the VA provide individualized feedback or technical guidance before release of the RFP?

Government Response: No. All clarifications and any updates to MTRs will be issued via presolicitation notices on SAM.gov to ensure equal access. No individualized guidance will be provided.

Q5. Are vendors disadvantaged if they did not respond to the June 26, 2026 RFI?

Government Response: No. RFI participation is voluntary and does not affect competitive standing. All vendors will have full and equal opportunity to compete once the solicitation is released.

Q6. Which NAICS code will VA use?

Government Response: NAICS 334510 (Electromedical and Electrotherapeutic Apparatus Manufacturing) is the correct NAICS for this procurement. NAICS 339113 does not apply.

Q7. Will vendors be required to submit product samples?

Government Response: Yes. Product samples for each proposed CLIN/SLIN must be shipped to the VA Denver Logistics Services (DLS) facility by the proposal deadline stated in the solicitation.

Q8. May offered devices rely on subscriptions, leases, user accounts, or smart-device applications?

Government Response: No. Devices must be fully operational at delivery and independent of subscription/rental/pay-per-use models or smart-device app dependencies.

Q9. Are refurbished, remanufactured, or gray-market items acceptable?

Government Response: No. Only new, OEM-manufactured products are acceptable.

Gray-market items are prohibited.

Q10. Will VA accept garment-based electrodes or alternate pad configurations?

Government Response: Yes. Alternate designs may be offered under the “Alternate Options” SLINs and must meet all SLIN-level MTRs.

Q11. Must devices include digital displays, adjustable parameters, dual-channel output, compliance monitors, and rechargeable power?

Government Response: Yes, these features are mandatory under applicable CLIN/SLIN MTRs.

Q12. Must devices include sensitive-skin/hypoallergenic electrode options?

Government Response: Yes, where applicable and stated in the CLIN/SLIN-level MTRs.

Q13. Is FDA 510(k) clearance required?

Government Response: Yes. All devices must have FDA 510(k) market clearance (or valid predicate) at proposal submission.

Q14. How will the VA apply BAA/TAA requirements under the Total SDVOSB set-aside?

Government Response: For this Total SDVOSB set-aside, the procurement will be structured to prioritize domestic end-products and require CLIN/SLIN-level country-of-origin certifications. In line with the Acquisition Plan, the VA intends to include both BAA (FAR Subpart 25.1) and TAA (FAR Subpart 25.4) provisions in the solicitation to ensure supply-chain compliance given the global device market. The solicitation will clearly explain how these provisions are applied and reconciled during evaluation.

Where domestic products are unavailable for specific CLINs/SLINs, the VA may consider BAA nonavailability waivers consistent with FAR 25.103.

Note: The previously published FAQ’s country examples tied to a TAA-only framework are informational and will be reconciled in the solicitation to avoid inconsistency with small-business set-aside rules and FAR Subpart 25.4. The final solicitation governs.

Q15. What is the required delivery timeframe and destination?

Government Response: Delivery must be made to the VA’s DLS facility by the timelines specified in the solicitation (standard delivery within 30 days ARO unless otherwise directed in a Delivery Order).

Q16. May vendors ship devices directly to Veterans?

Government Response: No. All ordered products must be delivered to DLS unless otherwise specified in a Delivery Order executed by an EPO AS4D Contracting Officer.

Q17. Must shipping containers include serial numbers and scannable barcodes?

Government Response: Yes. Serial numbers must appear on both the device and container; scannable barcodes must be included.

Q19. May contractors collect Veteran PII/PHI, therapy data, or require device registration?

Government Response: No. Contractors may not request, collect, or retain Veteran PII/PHI or medical treatment data; registration requirements are prohibited.

Q20. May the resultant performing Contractors initiate contact with Veteran patients?

Government Response: No. All contact must be Veteran-initiated; outbound contractor-initiated contact is prohibited.

Q21. Must contractors provide web-based and telephone technical support/customer service?

Government Response: Yes. U.S.-based toll-free phone support and compliant web-based customer service/training (no ads/logins/social media links) are required.

Q22. Will VA allow annual technical refresh?

Government Response: Yes. One technical-refresh window is available per period of performance, at the CO’s discretion. It requires no-cost samples for DLS testing and may involve negotiated unit pricing. Approval is not guaranteed.

Q23. Can the resultant performing Contractors request price changes during contract performance?

Government Response: No. Unit prices are Firm-Fixed Price (FFP) at award for the Base Year and all Option Years: fixed for all quantities, not subject to increase/decrease post-award, and applied uniformly for the entire contract life.

Q24. May contractors propose substitutions if OEM models are discontinued?

Government Response: Yes. Substitutions require formal EPO AS4D CO approval, documented MTR compliance, no-cost samples for DLS testing, and may involve negotiated unit pricing. Approval is not guaranteed.

Q25. Will the VA make multiple awards?

Government Response: Yes. Multiple single-award Base IDIQ contracts may be issued on a per CLIN/SLIN basis, followed by funded FFP/IDIQ Delivery Orders.

Q26. What source selection methods will be used?

Government Response:

CLINs/SLINs X001–X004 (COTS TENS/IFC/SWD): LPTA procedures.

CLIN X005 (Neuromodulation – Commercial item): Best Value Tradeoff (non-price factors significantly more important than price).

Socioeconomic Tiering: Prior to technical and price evaluation, offers will be evaluated than small businesses). If award can be made at a higher tier, lower tiers will not be evaluated.

Q27. Can more than one Offeror receive award for the same CLIN?

Government Response: Yes. Any CLIN/SLIN may be awarded to more than one responsible Offeror.

Q28. We observed a PSC discrepancy on SAM.gov—an ETMPM–TENS FAQ posting showed PSC “1190 – Specialized Test and Handling Equipment, Nuclear Ordnance,” while the RFI/Industry Day notices list PSC “6515 – Medical and Surgical Instruments, Equipment, and Supplies.” Which is correct?

Government Response: The correct PSC for this procurement is 6515. The August 12, 2026 SAM.gov FAQ posting included an erroneous PSC 1190 classification in posting metadata; earlier and other related postings reflect PSC 6515 and are correct. The VA will ensure future postings reflect PSC 6515. (References: Aug 12 FAQ posting—PSC 1190; Jan 20 Industry Days—PSC 6515; Jun 9 RFI—PSC 6515.).

Q29. How will the VA treat “Chinese Taipei/Taiwan” under designated-country considerations raised in prior Q&A?

Government Response: Under the Total SDVOSB set-aside, the VA will center evaluation on BAA requirements and country-of-origin certifications at the CLIN/SLIN level, with domestic end-products preferred. The Acquisition Plan indicates the VA intends to include TAA provisions given the global device market, and the solicitation will specify how BAA and any TAA provisions are applied and reconciled in evaluation.

Any previously published country lists tied to a TAA-only framework are informational and will be reconciled in the solicitation; the final solicitation governs eligibility determinations.

GOVERNMENT CLOSING STATEMENT: The VA extends its sincere appreciation to all industry participants who responded to the FY26 ETMPM–TENS RFIs. Industry input has informed refinement of MTRs, CLIN/SLIN structure, product categorization, evaluation methods (LPTA for COTS and Best Value Tradeoff for neuromodulation), delivery assumptions, and the acquisition strategy for a national, enterprise-wide FFP/IDIQ procurement. All finalized solicitation documents, including the RFP, CLIN/SLIN schedules, MTRs, pricing matrices, Offeror certifications, and all attachments will be published exclusively on SAM.gov, ensuring full transparency, equal access, and strict adherence to FAR/VAAR/VAAM procurement integrity standards. No additional or individualized guidance will be provided outside the official solicitation or presolicitation notices on the GPE.

Change Log (Synopsis of Key Updates):

Converted procurement to Total SDVOSB set-aside with VAAR 819.7010 tiered evaluation.

Clarified BAA/TAA application path under the set-aside and indicated reconciliation to be defined in the solicitation.

Added new Vendor Q&A addressing PSC 1190 vs. PSC 6515 and country-of-origin/Chinese Taipei treatment under the updated framework.

Reminder (FAR 15.201(e)): These FAQs are informational and non-binding. Final, enforceable requirements will appear only in the formal solicitation issued on SAM.gov.

Prepared By:

John Overstake Contract Specialist