Blood Pressure Monitors Bluetooth Enabled (BPM- BTE) Request for Information (RFI)

The Department of Veterans Affairs is conducting market research through a Request for Information to identify potential suppliers of automatic Bluetooth-enabled upper arm blood pressure monitors for home use by veterans. The devices must be FDA-cleared with a 510(k) premarket notification, clinically validated for accuracy, and compliant with ISO 81060-2:2018 including all amendments up to AMD2:2024, ensuring measurements are equivalent to those obtained by trained observers using traditional auscultation methods. Each monitor must automatically inflate and deflate, display systolic and diastolic blood pressure in mmHg and pulse rate in bpm, feature a visible on/off function, include a carrying case, and store a minimum of 60 readings with date and time stamps. The cuff must be latex-free, equipped with a standard D-ring for one-handed self-application, and available in four sizes: medium (23–37 cm), large (31–44 cm), wide/extended range (22–42 cm), and extra-large (44 cm and greater). The device packaging must include clear instructions for pairing with the VA’s Share My Health Data app and transmitting readings directly to the VA. Vendors must also demonstrate compliance with Section 508 accessibility standards, adhere to NIST FIPS cybersecurity guidelines, support ANSI X.12 EDI for electronic transactions, and ensure their manufacturing facilities are certified under relevant ISO standards and IEC 60601-1 and IEC 80601-2-30 medical device safety requirements. The VA requires information on business registration including UEI, CAGE, and DUNS numbers, SAM and SBA registry status, socio-economic certifications such as 8(a), HUBZone, WOSB, VOSB, or SDVOSB, and confirmation of TAA compliance. Responses must specify whether the firm is a manufacturer, distributor, or repackager, disclose any subcontracting arrangements, and provide details on product lead times and potential supply chain constraints. The place of performance is Golden, Colorado, and while no contract award is anticipated at this stage, all submissions must be provided by July 10, 2026, to inform future procurement planning under NAICS code 339112.