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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 that have quantitative imaging functions.

Premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, Premarket Notification (510(k)) submissions, Investigational Device Exemption (IDE) applications, and De Novo requests) for these devices are covered by this document, which should be used in conjunction with any existing device- or submission-specific guidance documents.


This guidance document clarifies that, in general, manufacturers preparing premarket submissions for radiological devices that include quantitative imaging functions which should provide performance specifications for the quantitative imaging functions, supporting performance data to demonstrate that the quantitative imaging functions meet those performance specifications, and sufficient information for the end-user to obtain, understand and interpret the values provided by the quantitative imaging functions.

Click this LINK to know in detail about this guidance.


Also, there was another guidance released this week "Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures" that provides the FDA’s recommendations on non-clinical performance testing to support premarket submissions for gynecologic and general laparoscopic power morcellation containment systems and may also help manufacturers comply with the special controls related to non-clinical performance data for these devices.

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enquiry mavenprofserv
enquiry mavenprofserv
07 июл. 2022 г.

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