Medical Device News FDA news 14-09-18 - Recognition and Withdrawal of Voluntary Consensus Standards

#2
Hi
I have a question regarding FDA and its Recognized Consensus Standards.

In their Database they refer to a ISO standard that has been withdrawn, e.g. ISO 10993-1 Fourth edition 2009-10-15
But acc. to ISO website Fourth edition is replaced by Fifth edition.

Can FDA still recognize invalid standards?

Thanks for any feedback.
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#3
Hi
I have a question regarding FDA and its Recognized Consensus Standards.

In their Database they refer to a ISO standard that has been withdrawn, e.g. ISO 10993-1 Fourth edition 2009-10-15
But acc. to ISO website Fourth edition is replaced by Fifth edition.

Can FDA still recognize invalid standards?

Thanks for any feedback.
Yes, in principle they can recognize whatever standard they want, unless the recognition rules say otherwise.

Please note that the publication if a standard by a SDO (standards development organization) is different from the application of a standard, for example, recognition by a regulator or inside a certification scheme. They are separate things.
 
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