This document provides guidance to manufacturers on the minimum requirements for the lifecyclemanagement of in vitro diagnostic (IVD) medical devices that are developed in preparation for and inresponse to a public health emergency involving infectious agents requiring immediate availability ofauthorized IVD devices.

NOTE: This document does not replace existing national (or regional) regulatory pathway requirements for IVD medical devices under non-emergency situations. The regulatory authorization process of emergency use-IVD medical devices is country-specific and it includes:

— following a risk management process;
— monitoring the device’s post-market performance and quality assurance;
— implementing a communication system.

Product Details

Published:

11/21/2024

ISBN(s):

9780539245929

Number of Pages:

22

File Size:

1 file , 1.5 MB

Product Code(s):

30464469, 30464469, 30464469

Note:

This product is restricted and cannot be purchased in the following countries Ukraine, Russia, Belarus