Amendment 0001 - QA and response date extension - CDRH-OSEL-26-C-D718.pdf
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- Solicitation number
- CDRH-OSEL-26-C-D718
About this file
This is an Amendment to a Combined Synopsis/Solicitation for procurement CDRH-OSEL-26-C-D718 issued by the U.S. Food and Drug Administration, Office of Acquisitions and Grants Services. The amendment publishes questions and answers from prospective quoters, extends the deadline for vendor questions to Wednesday, August 12, 2026, at 12:00 PM Eastern Time, and extends the quotation response date from July 29, 2026, to Monday, August 17, 2026, at 12:00 PM Eastern Time. All submissions must be sent by email to james.jenretteiii@fda.hhs.gov. Previously submitted quotations remain under consideration, and vendors may submit revised quotations until the new closing date.
The solicitation seeks a benchtop spectroradiometer with flexible microscope probes. Key clarifications from the Q&A include: the procurement comprises a spectroradiometer and a microscopy accessory; working distances for normal lenses are approximately 14 inches and macro lenses should focus at 2 inches or less; the imaging optic couples to the microscope through a fiber optic accessory and is not mounted inside the microscope; the 0.125-inch dimensional limit applies only to the fiber probe, not the imaging optic; and Item 0003 may be satisfied by either a conventional software development kit or a documented plain-text command interface with complete documentation, provided the instrument is open to communication with external devices. The evaluation basis is lowest-priced technically acceptable, and all other terms, conditions, and requirements of the original combined synopsis/solicitation and Statement of Work remain unchanged.
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AMENDMENT 0001
Combined Synopsis/Solicitation CDRH-OSEL-26-C-D718
Benchtop Spectroradiometer with Flexible Microscope Probes
U.S. Food and Drug Administration, Office of Acquisitions and Grants Services
1. Purpose of Amendment
This amendment (a) publishes questions received from prospective quoters with the Government’s answers,
(b) establishes a new deadline for further questions, and (c) extends the quotation response date. Any further questions are due no later than Wednesday, August 12, 2026, 12:00 PM Eastern Time. All quotations are due no later than Monday, August 17, 2026, 12:00 PM Eastern Time. Both shall be submitted by email to james.jenretteiii@fda.hhs.gov.
2. Questions and Answers
Q1. What is the working distance from the sample to the imaging optic that carries the interchangeable fields of view of 0.5, 1, and 2 degrees?
A. This procurement comprises two components: a spectroradiometer and an accessory for microscopy. The spectroradiometer will be used in a variety of applications, including microscopy, for which the accessory is required. Working distance depends on the lens supplied with the spectroradiometer: the closest working distance for a normal lens is approximately 14 inches, and a macro lens should focus at 2 inches or less.
Q2. What is the orientation of the imaging optic relative to the sample and the microscope optical axis?
A. When the instrument is used for microscopy, the spectroradiometer and the microscope are coupled through the fiber optic accessory. The interchangeable 0.5, 1, and 2 degree fields of view belong to the spectroradiometer lens and are used in non-microscopy applications, at the working distances stated in the answer to Q1.
Q3. Does the imaging optic need to be mounted inside the microscope system, or outside of it looking through a window?
A. The imaging optic is not mounted inside the microscope system. Coupling to the microscope is accomplished through the fiber optic accessory.
Q4. The Statement of Work states a maximum probe dimension of 0.125 inches. Does that limit apply to the imaging optic itself, or only to the fiber probe?
A. The 0.125 inch dimensional limit applies only to the fiber probe. It does not apply to the imaging optic.
The Statement of Work requirement is unchanged and reads: “Probe tip is 0.125” diameter.”
Q5. Item 0003 requires an SDK. Does a documented command set, on which a developer builds their own control, measurement, and analysis software, satisfy that requirement, or is a true SDK required?
A. A control interface based on a well-defined protocol using plain text for commands and responses, accompanied by complete and clear documentation, is considered a form of SDK. Accordingly, item 0003 may be satisfied either by a conventional software development kit or by a documented plain-text command interface meeting that description. The requirement is that the instrument be open to communication with external devices and that the control interface be completely and clearly documented.
3. Response Date
The deadline for vendor questions is reopened and extended to Wednesday, August 12, 2026, 12:00 PM Eastern Time. The quotation due date is extended from July 29, 2026 to Monday, August 17, 2026, 12:00 PM Eastern Time. Quotations previously submitted remain under consideration; quoters may submit revised quotations until the new closing date and time, and the most recent version received by close will be evaluated.
4. All Other Terms
All other terms, conditions, and requirements of the combined synopsis/solicitation, including the Statement of Work and evaluation basis (lowest-priced technically acceptable), remain unchanged.
5. Point of Contact
James Jenrette, Contracting Officer / Contract Specialist, OAGS: james.jenretteiii@fda.hhs.gov. All communications concerning this solicitation shall be directed to this point of contact in writing.
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