Attachment_1_Requirements_CDRH-2026-133952_Final.docx
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- Solicitation number
- 75F40126Q00360
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This is a requirements document for the acquisition of a single-axis linear motion calibration system (shake table) with integrated control software for the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH). The system must be a newly manufactured, commercial off-the-shelf scientific instrument delivered as a complete turnkey package, fully assembled, tested, and calibrated before shipment, requiring only unpacking, cable connection, and software installation by the end user. The acquisition includes manufacturer's warranty, user training, technical documentation, calibration certificates, and technical support throughout the equipment's initial service life.
The equipment must meet specific performance requirements across multiple parameters. The system shall operate with a single-axis linear motion architecture featuring closed-loop position control with real-time feedback and arbitrary waveform input capability. Minimum acceptable specifications include a frequency range of 0.1 Hz to 10 Hz, displacement range of 0.01 mm to 20 mm, acceleration range of 0.01g to 1g, and a payload capacity of 0.05 kg, with a minimum platform size of 50 mm × 50 mm. The system must achieve position accuracy of 2 percent of commanded value, position repeatability of 0.01 mm, frequency accuracy of 0.1 Hz or 1 percent, and a position noise floor of 0.005 mm RMS. At key frequencies (0.25 Hz, 5 Hz, and 10 Hz), the system must deliver specified minimum displacement and acceleration levels. The contractor shall provide bandwidth curves demonstrating achievable combinations of motion parameters, measured drift characterization data, and performance at small amplitudes. Preferred specifications are identified for enhanced performance metrics, evaluated as technical merit factors under a tradeoff basis.
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U.S. Food and Drug Administration Requirements Document – Attachment 1 Single-Axis Linear Motion Calibration System (Shake Table) with Control Software Scientific Equipment Purchase with Warranty and Ancillary Support
1. Purpose This document states the technical and supply requirements for the acquisition of a complete, turnkey single-axis linear motion calibration system capable of generating programmable motion profiles for calibration and testing purposes. The system shall be fully assembled, tested, calibrated, and ready upon delivery, requiring only unpacking, cable connection, and software installation by the end user. The acquisition includes the manufacturer's warranty, user training, technical documentation, and technical support.
2. Background The Center for Devices and Radiological Health (CDRH) within the U.S. Food and Drug Administration (FDA) requires a single-axis linear motion calibration system to support verification, calibration, and validation testing of inertial measurement devices. The acquisition includes the manufacturer's warranty and technical support to sustain performance over the equipment's initial service life.
3. Scope This acquisition includes:
1. Delivery and installation of the scientific equipment
1. The initial manufacturer's warranty
1. User training and technical support
1. Technical documentation and calibration certificates The equipment is a commercial off-the-shelf scientific instrument acquired as a supply action. The Government will not furnish property, equipment, information, or services. The Government will provide reasonable access to the installation location and designated personnel to coordinate installation and acceptance. The contractor shall provide all labor, materials, tools, equipment, transportation, software, and documentation necessary to satisfy the requirements.
4. Equipment Requirements All equipment shall be newly manufactured. It shall not be used, refurbished, reconditioned, remanufactured, or previously used for demonstration.
Specification and single-source need The equipment is specified by the minimum performance requirements stated in this Section 4, including motion architecture, performance envelope, accuracy, noise floor, mechanical tolerances, sensors, control performance, software, and physical and environmental limits.
Single make and model required: Not Applicable. No manufacturer or model is named; the equipment is specified by performance requirements.
Trade-in Not Applicable.
Motion architecture
1. Degrees of freedom: single-axis (1-DOF) linear motion
1. Control mode: closed-loop position control with real-time feedback
1. Programmability: arbitrary waveform input capability (required)
1. Turnkey operation: fully assembled, tested, and calibrated before shipment; user setup limited to unpacking, connecting cables, and installing software
1. Exclusion: pre-programmed calibrators with fixed routines only are not acceptable Minimum technical requirements The equipment shall meet the following requirements. Values in the “Acceptable” column are the minimum requirements the system must meet to be acceptable. Values in the “Preferred” column are desired; performance reaching toward the Preferred values is evaluated for technical merit under the tradeoff basis stated in the solicitation.
Motion performance envelope. The contractor shall provide bandwidth curves showing achievable combinations of displacement, velocity, acceleration, and frequency.
| Parameter |
| Acceptable |
| Preferred |
| Frequency range |
| 0.1 Hz to 10 Hz |
| 0.05 Hz to 20 Hz |
| Displacement range |
| ±0.01 mm to ±20 mm |
| ±0.005 mm to ±50 mm |
| Acceleration range |
| ±0.01g to ±1g |
| ±0.005g to ±3g |
| Payload capacity |
| 0.05 kg |
| 0.2 kg |
| Platform size |
| 50 mm × 50 mm |
| 100 mm × 100 mm |
Performance at key frequencies (minimum requirements).
| Frequency |
| Minimum displacement |
| Minimum acceleration |
| 0.25 Hz |
| ±10 mm |
| ±0.05g |
| 5 Hz |
| ±2 mm |
| ±0.5g |
| 10 Hz |
| ±0.5 mm |
| ±1g |
Motion accuracy and precision.
| Parameter |
| Acceptable |
| Preferred |
| Position resolution |
| 0.01 mm (10 µm) |
| 0.001 mm (1 µm) |
| Position accuracy |
| ±2% of commanded |
| ±1% of commanded |
| Position repeatability |
| ±0.01 mm |
| ±0.005 mm |
| Frequency accuracy |
| ±0.1 Hz or ±1% |
| ±0.05 Hz or ±0.5% |
| Amplitude accuracy |
| ±2% of commanded |
| ±1% of commanded |
Small-amplitude performance (critical).
| Commanded amplitude |
| Maximum position error |
| 0.1 mm |
| ±0.005 mm (±5%) |
| 1.0 mm |
| ±0.02 mm (±2%) |
| 10.0 mm |
| ±0.1 mm (±1%) |
Noise floor and stability. Position, acceleration, and velocity noise floor are minimum requirements. Drift (low-frequency and thermal) is evaluated as a technical-merit factor rather than a pass/fail minimum; the contractor shall provide measured drift characterization data, and lower, well-characterized drift increases the Government's confidence in the system.
| Parameter |
| Acceptable |
| Preferred |
| Position noise floor |
| 0.005 mm RMS |
| 0.001 mm RMS |
| Acceleration noise floor |
| 0.001g RMS |
| 0.0005g RMS |
| Velocity noise floor |
| 0.5 mm/s RMS |
| 0.1 mm/s RMS |
| Low-frequency drift (merit) |
| <0.05 mm over 60s |
| <0.02 mm over 60s |
| Thermal drift (merit) |
| <0.1 mm over 30 min |
| <0.05 mm over 30 min |
Dynamic performance.
| Parameter |
| Acceptable |
| Preferred |
| Settling time |
| <2 seconds to ±1% |
| <1 second to ±1% |
| Overshoot |
| <5% on step commands |
| <2% on step commands |
| Waveform fidelity (THD) |
| <5% |
| <2% |
| Multi-frequency fidelity |
| ±2% amplitude per component |
| ±1% amplitude per component |
Mechanical specifications.
| Parameter |
| Acceptable |
| Preferred |
| Backlash |
| <20 µm |
| <10 µm |
| Linearity |
| ±1% of full scale |
| ±0.5% of full scale |
| Hysteresis |
| <10 µm |
| <5 µm |
Motion types and programmability Basic waveforms: sinusoidal (fixed frequency), sinusoidal (swept frequency / chirp), step changes and transients, and ramp functions (constant velocity).
Complex waveforms: multi-frequency superposition (minimum three simultaneous frequencies), arbitrary waveform input (user-defined via file import or equations), custom motion profile generation, and recorded motion data replay.
Motion profile management: save and load custom profiles, import profiles from external sources (CSV, text, MAT files), export profiles for documentation, and organize a motion profile library.
Sensors and instrumentation Integrated position sensor (required).
| Parameter |
| Acceptable |
| Preferred |
| Notes |
| Type |
| Optical encoder, LVDT, or equivalent |
| Optical encoder |
| High reliability |
| Resolution |
| 0.01 mm |
| 0.001 mm |
| Digital quantization |
| Accuracy |
| ±0.02 mm |
| ±0.01 mm |
| Absolute positioning |
| Calibration |
| Manufacturer certificate |
| NIST-traceable |
| Traceability |
Integrated reference accelerometer (required).
| Parameter |
| Acceptable |
| Preferred |
| Notes |
| Range |
| ±3g |
| ±10g |
| Future-proof for fall testing |
| Resolution |
| 0.001g |
| 0.0005g |
| Fine motion detection |
| Noise floor |
| <0.001g RMS |
| <0.0005g RMS |
| Below physiological signals |
| Bandwidth |
| DC to 50 Hz |
| DC to 100 Hz |
| Capture harmonics |
| Accuracy |
| ±0.5% of reading |
| ±0.2% of reading |
| Reference quality |
| Calibration |
| Manufacturer certificate |
| NIST-traceable |
| Traceability |
Control system Closed-loop control performance.
| Parameter |
| Acceptable |
| Preferred |
| Notes |
| Control loop update rate |
| >1 kHz |
| >2 kHz |
| Real-time servo control |
| Position control accuracy |
| ±1% of commanded |
| ±0.5% of commanded |
| Steady-state error |
| Acceleration control accuracy |
| ±2% of commanded |
| ±1% of commanded |
| Dynamic accuracy |
| Stability |
| No limit-cycle oscillations |
| Critically damped response |
| Smooth motion |
Safety features (required): hard-wired emergency stop (not software-based only); position limit switches or software limits with hardware backup; over-current protection; fault detection with automatic safe shutdown; and clear visual or audible fault indication.
Software requirements All software licenses, activation keys, firmware, and permissions necessary for full operation of the delivered system shall be included in the contract price. The Government shall receive all licenses necessary for operation. Unless otherwise specified in the contractor's quotation, licenses shall be perpetual and transferable within the agency.
The system shall operate in a standalone configuration and shall not require continuous internet connectivity, cloud-based services, or subscription-based access for normal operation unless specifically identified in the contractor proposal.
Control software (required): programmable control interface via MATLAB, Python, or equivalent industry-standard programming environment; a standalone graphical user interface (preferred but not required); operating system compatibility with Windows 11 (64-bit), backward compatible with Windows 10 (64-bit); an application programming interface with documentation and a minimum of five example scripts; and data import and export in CSV, MAT, or equivalent non-proprietary formats. Sample physiological motion profiles (breathing, tremor, multi-component) are strongly preferred.
Data acquisition and logging.
| Parameter |
| Acceptable |
| Preferred |
| Sampling rate |
| ≥1 kHz |
| ≥5 kHz |
| Timestamp resolution |
| ≤1 ms |
| ≤0.2 ms |
| Simultaneous sampling |
| All channels synchronized |
| Hardware-synchronized |
| Continuous recording |
| 10 minutes minimum |
| 60 minutes |
Minimum logged channels: commanded position, actual (measured) position, velocity (commanded and/or measured), and acceleration (commanded and measured).
Input / output capabilities.
| I/O type |
| Acceptable |
| Preferred |
| Specification |
| Trigger inputs |
| 2 channels |
| 4 channels |
| TTL or equivalent, BNC or similar |
| Trigger outputs |
| 2 channels |
| 4 channels |
| TTL or equivalent, BNC or similar |
| Analog inputs |
| 2 channels |
| 4 channels |
| ±10V, 16-bit minimum |
| Digital I/O |
| 4 channels |
| 8 channels |
| 5V TTL or 3.3V CMOS |
Physical, power, and environmental Physical.
| Parameter |
| Acceptable |
| Preferred |
| Footprint |
| ≤1 m × 1 m |
| ≤0.5 m × 0.5 m |
| Mounting |
| Benchtop (no floor reinforcement) |
| Benchtop with vibration isolation |
| Weight |
| <30 kg |
| <20 kg (single person portable) |
| Noise level |
| <70 dB during operation |
| <60 dB |
| Vibration isolation |
| Self-contained |
| Self-contained with damping |
Power.
| Power parameter |
| Specification |
| Voltage |
| 110-120V AC, 50-60 Hz (or 100-240V universal) |
| Power conditioning |
| No specialized conditioning required |
| Emergency stop |
| Must cut power to motion system |
Environmental.
| Parameter |
| Acceptable |
| Preferred |
| Operating temperature |
| 15-30°C |
| 18-25°C |
| Operating humidity |
| 20-80% RH non-condensing |
| 30-70% RH non-condensing |
| Storage temperature |
| 0-40°C |
| 5-35°C |
| Storage humidity |
| 10-90% RH non-condensing |
| 20-80% RH non-condensing |
Performance documentation required at delivery The contractor shall provide measured performance data demonstrating compliance with the specifications above:
1. Noise floor measurements: position and acceleration noise (RMS) at 0.25 Hz, 5 Hz, and 10 Hz
1. Stability data: measured drift characterization over 10 or more minutes of continuous operation
1. Mechanical performance: backlash (minimum five positions), linearity, and hysteresis measurements
1. Accuracy data: positioning accuracy at 0.1 mm, 1.0 mm, and 10.0 mm amplitudes
1. Multi-frequency capability demonstration: sample data showing simultaneous multi-component waveform
1. Factory calibration certificates for all sensors with calibration dates and next-due dates (NIST-traceable strongly preferred), with uncertainty budgets
5. Information Technology and Accessibility The system operates in a standalone configuration and does not require connection to an FDA network for normal operation. It includes companion control software that stores data locally. The final network posture will be confirmed with the Contract Specialist during solicitation.
Section 508: any software, graphical user interface, electronic documentation, or electronic content provided under this contract shall comply with the applicable Section 508 accessibility requirements of the Rehabilitation Act (29 U.S.C. 794d) and the Revised 508 Standards. The contractor shall provide a completed Voluntary Product Accessibility Template (VPAT) or equivalent accessibility conformance documentation, addressing WCAG 2.0 Level A and AA (or the current applicable standard), functional performance criteria, electronic content accessibility, and support documentation accessibility. The VPAT or equivalent shall be submitted prior to Government acceptance.
6. Warranty Requirements Consistent with RFO 12.105(b), the Government will accept the contractor's standard commercial warranty to the maximum extent practicable and use that warranty for the repair and replacement of the equipment. The warranty shall provide, at a minimum:
1. A full manufacturer's warranty of twelve (12) months from the date of final acceptance
1. Warranty coverage of all parts, labor, and remote technical support required to return the system to full operating condition, at no additional cost to the Government
1. Software updates and technical support by phone or email for a minimum of one (1) year
1. Clear procedures for warranty claims and technical support requests, and a recommended maintenance schedule
7. Ancillary Maintenance Requirements Not included. This acquisition does not include post-warranty preventative maintenance option years.
8. Training and Documentation The contractor shall provide:
1. A minimum of two remote training sessions totaling at least four (4) hours for up to five (5) Government personnel, covering operation, programming, troubleshooting, preventive maintenance, and data acquisition functionality, with recorded sessions and training materials
1. A quick start guide, user manual, application programming and interface documentation, and safety and compliance documentation, in electronic format
1. Power consumption specifications and a knowledge base or online resources
1. Safety data sheets (SDS), if applicable
9. Delivery and Installation
1. Equipment shall be delivered to: U.S. Food and Drug Administration, White Oak Building 62, Room 1135, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002
1. Delivery shall occur within 90 calendar days of award
1. Installation shall be completed within 10 days of delivery
1. The contractor is responsible for all setup, calibration, and verification of system performance, with installation support provided remotely or on-site as agreed
1. For all on-site work, contractor personnel shall report to security at White Oak Building 62, who will contact the Contracting Officer's Representative (COR) or the COR's designee. On-site work shall be performed during standard business hours, 9:00 a.m. to 5:00 p.m. ET, Monday through Friday, unless otherwise directed by the COR.
Packaging and marking Equipment shall be packaged and transported in accordance with manufacturer recommendations to prevent damage during shipment, protecting the equipment from shock, vibration, moisture, dust, and environmental hazards. Shipping containers shall be suitable for commercial carrier transport.
Deliverable schedule
| Deliverable |
| Quantity |
| Due date |
| Motion system |
| 1 EA |
| Within 90 days of award |
| Software, licenses, and documentation |
| 1 EA |
| Within 90 days of award |
| Installation |
| 1 EA |
| Within 10 days of delivery |
| Calibration certificates |
| 1 LOT |
| At delivery |
| Warranty documentation |
| 1 EA |
| At delivery |
| VPAT / Section 508 documentation |
| 1 LOT |
| Prior to Government acceptance |
10. Acceptance Criteria The Government will inspect and test the equipment upon installation. The system shall be considered acceptable upon:
1. Successful unpacking and installation with contractor support
1. Verification that all deliverables in this document are provided
1. Demonstration that the system meets the minimum (Acceptable-column) specifications in Section 4 in all categories
1. Successful execution of basic motion profiles (sinusoidal, step, ramp) and verification of data logging and software functionality
1. Confirmation that all safety features operate as specified
1. Completion of training and receipt of all documentation and calibration certificates The Government will complete inspection and acceptance within five (5) business days following installation and receipt of all required documentation. Final acceptance authority rests solely with the Government through the Contracting Officer. Government acceptance is required prior to final payment.
The warranty period begins at final Government acceptance.
11. Holidays and Government Closures The contractor is not required to perform on-site services on the following Federal holidays, or on any other day designated as a holiday for the Washington, DC area:
1. New Year's Day
1. Martin Luther King Jr. Day
1. Presidents' Day
1. Memorial Day
1. Juneteenth National Independence Day
1. Independence Day
1. Labor Day
1. Columbus Day
1. Veterans Day
1. Thanksgiving Day
1. Christmas Day
1. Inauguration Day (every four years, for performance sites in the DC area)
12. Points of Contact See contract for points of contact.
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