SAM #FDA_RFQ_CDRH_2026_133635

FDA Solicitation for Collaborative Robotic Arm System and Related Equipment

This FDA procurement opportunity seeks a collaborative robotic arm system to advance regulatory science research in medical device evaluation. - Government Buyer: - U.S. Food and Drug Administration (FDA) - Center for Devices and Radiological Health (CDRH) - Office of Science and Engineering Laboratories (OSEL) - OEMs and Vendors: - No specific OEMs or vendors are named; open to any manufacturer meeting requirements - Products/Services Requested: - Collaborative robotic arm with 6 rotating joints - Payload: 5-10kg - Reach: 750-950mm - Repeatability: <0.035mm - Weight: <30kg - Protection: IP40 or higher - Standard mounting, cable length ≥2m, footprint <175mm x 175mm - Controller - Power: 120V 50-60Hz AC preferred (220V acceptable) - Size: ≤500mm x 500mm x 500mm - Minimum 8 digital I/O ports, 2 analog input ports, 2 USB ports, 1 Ethernet port, 1 display port - Teach pendant/control box - Touchscreen ≥8 inches - Emergency stop switch - Wireless or cable connectivity (≥2m) - Weight: <3.5kg - Robotic arm control software - TCP calibration procedure - Permanent license - SDK with API and libraries - Compatible with Windows 10/11 and Linux - Supports third-party software (LabVIEW, MATLAB, Visual Basic, C++, C#, Python) - Unique/Notable Requirements: - Equipment must be new, calibrated, ISO 9283 certified - Delivery required within 60 days of award - 12-month warranty and technical support included - System will be used for precise control and evaluation of surgical tools and head mounted displays - Must align with FDA recognized standards - Delivery Location: - FDA CDRH DIDSR, Silver Spring, Maryland

Description

Notice of Combined Synopsis/Solicitation. This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with part 12. This announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation will not be issued.   Background:

The procurement is to support regulatory science tools development for the Interventional, Radiological Imaging and Visualization regulatory science research program. Developing measurement methodologies for technical performance is critical for consistent evaluation of head mounted displays and image registration in interventional procedures. Specifically, the procurement for a robotic arm to precisely control the position and orientation of surgical tools to quantitatively characterize the spatial and temporal stability and accuracy of image registration. In addition, the robotic arm will also allow for controlled movement of an augmented and virtual reality head mounted displays (HMDs) or camera system to evaluate registration performance visualized through the HMD including simulated user movement. 

These types of technologies are increasingly being incorporated in medical devices across OPEQ. The range of motion of the robotic arm will allow for developing image registration regulatory science tools for a wider range of device types with more complex motions than are achievable with a linear translation stage. Finally, the robot will allow for greater flexibility in targets and cameras for characterizing registration using HMDs. This will align the Office of Science and Engineering Laboratories (OSEL) instrumentation with FDA recognized standards, such as the Instrumental Commission (IEC), for head mounted displays, which is essential for the OSEL mission of developing regulatory science tools. The collaborative robotic arm will be incorporated into an existing bench setup using custom developed software for controlling a collaborative robotic arm.

 Minimum Performance Requirements:

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)      TCP location: Should support both TCP locations     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).     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, including in an emergency and by user request. • Repeatability: less than 0.035 MM • Weight: less than 30kg • 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:      Digital input ports: min 8 ports      Digital output ports: min 8 ports      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 length of 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

Deliverables: 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.

Place of Supply Delivery and Place of Performance:

The equipment should be complete with all accessories and software necessary to work and to be delivered to:

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 Email: Ryan.Beams@fda.hhs.gov

Period of Performance:

12 consecutive months commencing upon date of Award.

Please see the attached Statement of Work and corresponding ancillary documents for review and consideration. 

Quotes are due by email on or before September 11, 2025, by 4:00 P.M. (Eastern Standard Time) and should be sent to brandon.rafus@fda.hhs.gov.

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