IFU(Instruction for Use ) in IVD Industry|IFU Labelling| How I draft IFU|Product Insert|Kit Insert.

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IFU(Instruction for Use ) in IVD Industries| IFU Labelling| How I draft IFU| Product Insert|Leaflet.
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Instructions for use (IFU): Information supplied by the manufacturer to enable the safe and proper use of an IVD. Note: Includes the directions supplied by the manufacturer for the use, maintenance, troubleshooting and disposal of an IVD, as well as warnings and precautions

The instructions for use (IFU) is a critical part of an in vitro diagnostic medical device (IVD);
it is expected to effectively communicate the product information to the intended user
and ensure the safe use of the IVD. The IFU communicates the purpose for which the IVD
should be used, who should use it, how the IVD works, what types of specimens it should
be used with, what materials and reagents are needed to perform the IVD, how to
perform the test, how to interpret the test result, the limitations of the test, warnings
and precautions that need to be considered when using the IVD, and evidence to support
IVD performance claims.

It therefore communicates all that the user needs to know to make good clinical use of the IVD.
Any information that the manufacturer includes in the IFU should be supported by
documentation; for example, the results of well-controlled studies to substantiate
performance claims, and manufacturing specifications for the stated composition of test
kit components. Manufacturers have a regulatory responsibility to ensure the safe use of
their product

Intended use: The objective intent of the manufacturer regarding the use of a product, process or
service as reflected in the specifications, instructions and information provided by the
manufacturer

n vitro diagnostic medical device (IVD): A medical device, whether used alone or in combination, intended by the manufacturer for the in vitro examination of specimens derived from the human
body, solely or principally to provide information for diagnostic, monitoring or
compatibility purposes. Note: IVDs include reagents, calibrators, control materials, specimen receptacles, software and related instruments or apparatus or other articles. They are used, for
example, for the following test purposes: diagnosis, aid to diagnosis, screening,
monitoring, predisposition, prognosis, prediction, determination of physiological status

Technical Guidance Series (TGS) for WHO Prequalification – Diagnostic Assessment
Designing instructions for use for in vitro diagnostic medical devices

List of Queries-
What is IFU
What is Instruction of Use
How to make IFU
How to design IFU
How to draft IFU
IFU Kaise banate hai
IFU kya hota hai
IFU for IVD Industries
IFU Standard




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