After publishing an initial guidance on the topic three years ago, the Food and Drug Administration has issued its final guidance for manufacturers submitting radiological devices that use quantitative imaging for premarket review.
The document, “
FDA Issues Final Guidance For Radiological Devices Using Quantitative Imaging
Document updates agency’s 2019 guidance
The US FDA has published its final guidance for premarket submissions of radiological devices that use quantitative imaging – technology which offers clinicians a more accurate picture of a disease.
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