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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FDA Leaves Global Harmonization Working Party, Will Focus International Harmonization Efforts Elsewhere
Three years after joining, the US FDA announced its withdrawal from the Global Harmonization Working Party and intention to focus its work on medical device harmonization through its collaboration with the International Medical Device Regulators Forum.
The US FDA has published final guidance requiring firms to notify the agency about significant manufacturing interruptions of medical devices during a public health emergency, as well as a supplementary draft guidance that includes a list of specific devices that manufacturers must report to the agency when they are in short supply.