FDA-recognized Standards

shimonv

shimonv

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#1
A riddle:
In the past FDA required the use of Form 3654 when referencing national or international standards for demonstrating substantial equivalence.
In efforts to reduce paperwork and "Least burdensome approach" Form 3654 is no longer needed. But, however, the manufacturers are required to submit their own declaration. Did anyone figured out their logic?

Shimon
 
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