Zdrowie i gospodarka · 4/19/2019
Technical Performance Assessment of Quantitative Imaging in Premarket Device Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Technical Performance Assessment of Quantitative Imaging in Premarket Device Submissions." This draft guidance document provides recommendations on the information that should be included in premarket submissions for devices that include quantitative imaging functions. This draft guidance is not final nor is it in effect at this time.