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USFDA Guidance on Technical Performance Assessment of Quantitative Imaging in Radiological Device
According to the guidance document, FDA recommends what information should be included in a premarket submission for radiological devices...

Sharan Murugan
Jun 18, 20221 min read
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Draft MD Guidance on Performance Criteria for Safety and Performance Based Pathway - USFDA
On 30th August 2021, the Center for Devices and Radiological Health released 2 new draft guidance related to Premarket, 510(k). i.e.,...

Sharan Murugan
Aug 30, 20211 min read
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