On September 18, 2026, National Institute of Standards and Technology (NIST) published Request for Information - future medical metrology and standards needs. NIST requests information on future measurement, validation and standards needs for medical imaging, devices, diagnostics and therapies, including technologies that incorporate artificial intelligence.
Status and timing: Request for Information; comments are due November 30, 2026.
Impact
Impact assessment: High.
Key reasons: The consultation can define the future technical infrastructure for evaluating medical devices and AI systems. On September 18, 2026, National Institute of Standards and Technology (NIST) published Request for Information; future medical metrology and standards needs. NIST requests information on future measurement, validation and standards needs for medical imaging, devices, diagnostics and therapies, including technologies that incorporate artificial intelligence.
Who is affected?
Medical device manufacturers, Medical AI developers, Metrology laboratories, Standards bodies.
Conclusion:
Manufacturers and laboratories should review questions, document metrological needs and consider comments by November 30.
Regulatory Authority
National Institute of Standards and Technology (NIST)
Regulatory Impact
| Impact Type | Status |
|---|---|
| Top Priority | |
| Type Certificate | |
| Spectrum Bands | |
| Import Changes (HS Codes) | |
| Standard Changes | |
| Product Changes | |
| Label Changes |