Opportunity Overview
The U.S. Food and Drug Administration, Office of Acquisition and Grants Services, is soliciting a complete interoperable endoscopy system for the Office of Science and Engineering Laboratories, Division of Imaging, Diagnostics, and Software Reliability (OSEL-DIDSR) in Silver Spring, Maryland. The system will support bench-test method development for evaluating endoscopy device safety and effectiveness.
Solicitation, Deadline and Submission Controls
Solicitation: 75F40126Q00381
Type: Combined Synopsis/Solicitation
Issuer: U.S. Food and Drug Administration, Office of Acquisition and Grants Services
Place of performance/delivery: 10903 New Hampshire Avenue, WO62-3133, Silver Spring, MD 20993
Deadline: September 16, 2026 at 3:00 PM EDT
NAICS: 423490, Other Professional Equipment and Supplies Merchant Wholesalers
PSC: 6640, Laboratory Equipment and Supplies
Set-aside: None
Published contract ceiling: None stated. Pricing is controlled by the official quote package.
Match/cost share: Not applicable to this procurement.
Contacts: Pamela T. Lee, pamela.lee@fda.hhs.gov, 240-402-3847; Madeline Bryant, madeline.bryant@fda.hhs.gov, 240-402-7611.
SAM.gov was updated on September 14, 2026 with Amendment 0001. The original solicitation document was replaced by 75F40126Q00381_amend0001.docx and an SF-30 amendment file. The current response deadline remains September 16, 2026 at 3:00 PM Eastern Time. Respondents should review the complete current amendment and solicitation attachments in SAM.gov before relying on any submission method, form, or package requirement. Respondents must review Amendment 0001 and the current SAM.gov attachment set before quoting; do not rely on the superseded original document alone.
Technical Requirements
The required system must include an interoperable video processor, colonoscope, medical display, and cart capable of acquiring and displaying live images. The video processor must be an FDA-cleared 510(k) device with an integrated LED light source, white-light mode, at least two FDA-cleared narrow-band imaging modes, at least two FDA-cleared digital color-enhancement modes under product code PEA, specified 12G-SDI, 3G-SDI and HD-SDI outputs, and still-image/video capture capability. The colonoscope must also be FDA-cleared 510(k), forward viewing, with at least a 170-degree field of view, 5-100 mm or wider depth of field, specified angulation, water nozzle, insertion tube diameter no greater than 12.8 mm, and instrument channel diameter at least 3.7 mm. The medical display must be at least 32 inches and 4K with 12G-SDI, 3G-SDI, DisplayPort, HDMI and DVI inputs. All components must operate on U.S. 120V/60Hz power.
Shipping must be included in the purchase price. Delivery is required within six weeks after award. The system must include at least a one-year warranty covering parts, labor, travel and shipping necessary to return the system to OEM standards, with the solicitation also calling for a one-year warranty period following system acceptance.
Vendor Qualification and Response Controls
This is a full-and-open federal supply procurement with a narrowly defined technical specification and a short response window. Any respondent should treat exact technical compliance, current amendment review, complete pricing, warranty coverage, delivery timing, and SAM.gov eligibility as threshold response controls.
The requirement is for a complete interoperable endoscopy system. General telehealth, unrelated diagnostic, or non-endoscopy products do not satisfy the stated specification.
A responsive vendor must be able to document a legitimate source for a new system that satisfies every required FDA clearance, imaging mode, output, display, warranty, and delivery condition. Capability should be demonstrated with current manufacturer or distributor documentation rather than inferred from general healthcare-technology experience.
Do not submit a quote unless the responding organization can substantiate exact specification compliance, current SAM.gov eligibility, complete pricing, warranty support, and delivery within the required period.
Supplier Qualification
Potential suppliers should be screened for current authority to furnish a new compliant system, not merely repair or service capability. Verify the offered manufacturer and models, applicable 510(k) clearances, all required imaging and interface specifications, warranty terms, delivery capability, and any representations required by Amendment 0001 before treating a supplier as responsive.
Response Checklist
Before submitting a quote, review the current SAM.gov notice, Amendment 0001, the SF-30, and the amended solicitation document. Confirm the exact email submission instructions, subject line, required representations or attachments, offered-system compliance, price, shipping, warranty, and six-week delivery commitment. Because the response deadline is September 16, 2026 at 3:00 PM Eastern Time, prospective vendors should use the current amended package rather than any superseded local copy.
Official source: SAM.gov — 75F40126Q00381.