SOW-CDER-2026-133635-for SAM Posting.pdf
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- Robotic Arm
- Solicitation number
- FDA_RFQ_CDRH_2026_133635
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Summary: Statement of Work for Commercial Products
Tracking Number: FDA-RFQ-CDRH-2026-133635
This Statement of Work is a Request for Quote (RFQ) from the FDA's Center for Devices and Radiological Health (CDRH), Office of Science and Engineering Laboratories (OSEL), for the procurement of a 6-axis collaborative robotic arm system with supporting equipment. The procurement supports regulatory science tools development for the Interventional, Radiological Imaging and Visualization regulatory science research program, enabling precise control and measurement of surgical tool positioning, image registration accuracy, and augmented/virtual reality head-mounted display (HMD) evaluation in interventional procedures.
The solicitation requires four items: (1) a collaborative robotic arm with 6 rotating joints, 5-10kg payload, 750-950mm reach, minimum 0.035mm repeatability, and less than 30kg weight; (2) a controller with 120V AC power (220V acceptable), minimum 8 digital input/output ports, 2 USB ports, 1 Ethernet port, and maximum dimensions of 500mm x 500mm x 500mm; (3) a teach pendant/control box with 8-inch or larger touchscreen, emergency stop button, wireless or 2-meter cable connectivity, and less than 3.5kg weight; and (4) software with TCP calibration capability, permanent licensing, Windows 10/11 or Linux compatibility, and support for third-party integration (LabVIEW, MATLAB, Python, C++, C#, Visual Basic). All equipment must be new and non-refurbished, operate in 15-30°C temperature range at 90% relative humidity, produce less than 65dB noise, include ISO 9283 certification, and carry a minimum 1-year warranty. Delivery is required within 60 days of award, with all quotes including shipping and handling costs. Optional items include a gripper, additional I/O controller expansion, adapter plates, and enhanced ingress protection. Technical and software support must be available during normal business hours, with robot calibration and recalibration services provided pre-delivery and on-site as needed.
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STATEMENT OF WORK FOR COMMERCIAL PRODUCTS
Tracking Number: FDA-RFQ-CDRH-2026-133635
: FDA
Laboratory: CDRH/OSEL
1. Summary
The procurement is for a 6-
2. Background
The procurement is to support regulatory science tools development for the regulatory science research program arm to precisely control th will also allow for controlled movement of an augmented and virtual reality head mounted displays (HMDs) or user movement regulatory science tools f cameras HMDs
Header
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3. Items Item Number
1 1 Unit 2 Controller 1 Unit
3 Control box for programming the called a teach
1 Unit
4 1 Unit
4.
Item 1:
Collaborative Robotic Arm
Degrees of Freedom: 6 rotating joints Payload: 5-10kg Reach: 750-950 mm Tool Movement at Tool Center Point (TCP):
o TCP location (options):
100-200mm from center of face-plate on tool z-axis (along rotation axis of joint 6) 100-200mm from center of face-plate on the tool x-axis (orthogonal to rotation axis of joint 6).
o Range of TCP movement (position and orientation) X: at least 150mm Y: at least 150mm Z: at least 150mm Yaw angle: at least +/- 45o
Pitch angle: at least +/- 45o
Roll angle: at least +/- 20o
Maximum speed per joint: at least 180o/s Maximum TCP velocity: at least 0.5 m/s Joint movable range: Minimum rotation angle of each joint of all six joints must be more than 220o.
Position detection: encoders Brakes mechanism that locks and unlock joint as needed, including in an emergency and by user request.
Repeatability: less than 0.035 mm Weight: less than 30kg
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Protection and Sealing of the robot: Protection from tools and small wires, such as IP40 or higher.
Mounting: Standard required. Optional for side or inverted mounting.
Cable length: at least 2 m Footprint Size: less than 175 mm x 175 mm
Item 2:
Controller
Power: 120V 50-60Hz AC preferred, 220V acceptable.
Maximum Controller size (W x H x D): 500 mm x 500 mm x 500 mm I/O ports:
o Digital input ports: min 8 ports o Digital output ports: min 8 ports o Analog input ports: min 2 ports
USB ports: min 2 ports (2.0 or 3.0) Ethernet port: min 1 port Display port for external screen: min 1 port.
Item 3: A control box for programming the motions of a robot. Also called teach box or teach pendant.
Manually move and reorient the robotic arm Ability to program using GUI through the teach pendant.
Touch screen of a size 8 in or larger Emergency stop switch/button.
Connectivity: Wireless or by a cable of length at least 2 m Weight: less than 3.5 kg
Item 4:
Software
Tool Center Point (TCP) calibration procedure Permanent software license Support for controlling the robotic arm and camera systems with third party software, such as LabVIEW, MATLAB, Visual Basic, C++, C#, or Python. Support may include a software development kit (SDK) with all required application programing interface (API) and libraries for software development, drivers, or ActiveX support.
Compatible with Windows 10, Windows 11, or Linux Operating System
GENERAL REQUIREMENTS
New and non-refurbished equipment Humidity: 90% RH (non-condensing) Temperature: workable in temperature range 15°C < temp < 30°C Noise: less than 65 dB Technical Support: Available during normal business hours Software Support: Available during normal business hours
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Quotes must Include all Shipping and Handling cost Robot Calibration: Robot joints must be calibrated prior to delivery, including calibration certificate or test report.
Robot Recalibration: Provide support for robot recalibration as needed, including calibration at supplier’s facility or on-site at FDA facility.
Robot base plate (mounting plate) for fast installation in different locations.
ISO certification: ISO 9283 Warranty: 1 year or more
Optional Items Item gripper:
o Stroke of the gripper: at least 125mm o o o o Grip Force: 20 to 100 N
Additional I/O for Controller:
o Expansion slot for additional I/O boards on controller o Analog output ports
Adapter plates: 2 to 4 adapter plates for mounting camera system on faceplate of robot.
Ingress protection: IP40 or higher
5. Delivery
The Contractor shall deliver the item and quantities ordered within 60 days of award.
All deliverables required under this contract shall be packaged, marked, and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and contractor’s name. The Contractor shall guarantee that all required materials shall be delivered in immediate new, usable, and acceptable condition.
US FDA CDRH DIDSR
Attention: Beams, Ryan 10903 New Hampshire Avenue
WO62 RM 3126
Silver Spring, Maryland 20993
PH: 240-402-3216
Fax: 301-796-9925
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6. -up (if applicable)
N/A
7.
User manual Technical and business
8. 8. Warranty and Maintenance (if applicable
Warranty of 1
9. Quality Assurance (if applicable)
N/A
10. Security Requirements (if applicable)
N/A
11.
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12. (if applicable)
N/A
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