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Sharan Murugan
Jun 18, 20221 min read
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...
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Sharan Murugan
Aug 30, 20211 min read
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On 30th August 2021, the Center for Devices and Radiological Health released 2 new draft guidance related to Premarket, 510(k).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.,...
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