Combined Synopsis.docx

Combined Synopsis/Solicitation Solicitation Number: 75F40125Q00431

1. Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a separate written solicitation will not be issued.

This solicitation is issued as a Request for Quote (RFQ) under FAR Part 13 – Simplified Acquisition Procedures. The solicitation number is 75F40125Q00431.

This acquisition is 100% Full and Open Competition. The NAICS code is 339112 – Surgical and Medical Instrument Manufacturing, with a small business size standard of 1,000 employees. The PSC code is 6515 Medical and Surgical Instruments, Equipment, and Supplies.

The U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), requires a fully functional endoscope system to support medical device regulatory science research conducted by the Office of Science and Engineering Laboratories (OSEL).

2. Line Items / CLINs

3. Requirements Document See full Requirement Document (attached). The scope includes:

· Delivery of an FDA-cleared 510(k) endoscope system.

· Includes all components (video processor, light source, colonoscope, display, cart).

· Must support advanced imaging modes and specified input/output.

· System warranty of at least one (1) year required.

· Shipping included in the total price.

Delivery Address:

10903 New Hampshire Ave

WO62-3133, US FDA

Silver Spring, MD 20993-0002 Delivery is required within six (6) weeks of contract award.

4. Instructions to Offerors

· Quotes must include:

· Technical description meeting or exceeding all specifications.

· Proof of FDA 510(k) clearance for the video processor and colonoscope.

· Delivery timeframe.

· Warranty terms.

· DUNS/UEI and CAGE Code.

· Offerors must be registered in SAM (www.sam.gov).

· All quotes must be submitted electronically to:

Contracting Officer: Jennifer Mun at Jennifer.mun@fda.hhs.gov

Deadline for quote submission: September 18, 2025, at 12:00 PM EST.

5. Evaluation Criteria Award will be made to the Lowest Price Technically Acceptable (LPTA) offeror that:

· Meets all technical requirements in the SOW.

· Provides evidence of FDA 510(k) clearance where required.

· Meets delivery and warranty terms.

See attached Evaluation Criteria for more details.

6. Contract Clauses and Provisions Applicable Provisions (Incorporated by Reference):

· FAR 52.212-1, Instructions to Offerors—Commercial Items

· FAR 52.212-2, Evaluation—Commercial Items (fill-in: LPTA)

· FAR 52.212-3, Offeror Representations and Certifications—Commercial Items (Offerors must complete this via SAM) Applicable Clauses (Incorporated by Reference):

· FAR 52.212-4, Contract Terms and Conditions—Commercial Items

· FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items (see applicable clauses below) FAR 52.212-5 - Applicable Paragraphs:

· 52.203-6, Restrictions on Subcontractor Sales to the Government

· 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards

· 52.209-6, Protecting the Government’s Interests Against Debarment

· 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns

· 52.219-28, Post-Award Small Business Program Rerepresentation

· 52.222-3, Convict Labor

· 52.222-19, Child Labor—Cooperation with Authorities and Remedies

· 52.222-21, Prohibition of Segregated Facilities

· 52.222-26, Equal Opportunity

· 52.222-36, Equal Opportunity for Workers with Disabilities

· 52.225-1, Buy American—Supplies

· 52.232-33, Payment by Electronic Funds Transfer—System for Award Management

7. HHS and FDA-Specific Clauses

· 352.239-73: Electronic and Information Technology Accessibility

· 352.239-74: Electronic and Information Technology Accessibility Notice

· 352.223-70: Safety and Health

· 352.237-75: Key Personnel (if applicable)

· 352.211-1: Public Accommodations and Commercial Availability of FDA-Cleared Medical Devices

· FDAAR 1052.232-400: Invoice Submission (Invoice instructions will be provided at award)

· FDAAR 1052.239-400: Security of Systems Processing Unclassified Information (not applicable if system is standalone and not connected to FDA networks)

8. Warranty and Acceptance

· System shall include one (1) year total warranty.

· System shall be inspected and accepted by the Technical Point of Contact (TPOC) upon delivery.

9. Attachments

· Attachment 1 – Requirements Document

· Attachment 2 – Evaluation Criteria