HI - Not sure if I titled this correctly-I have been reading regulations and consensus standards to understand them and see how they line up - self-training.
If I am interpreting correctly, the FDA regulation and 60601-1 seem to conflict regarding whose name / contact info. goes on the label for a private branded product.
FDA regulations state that Distributed by or Manufactured for is acceptable.
60601-1 states the name of the manufacturer / trademark / contact information must be on the label.
Does FDA or 60601 take precedence for private branded products?
Thank you for any explanation you can provide -
If I am interpreting correctly, the FDA regulation and 60601-1 seem to conflict regarding whose name / contact info. goes on the label for a private branded product.
FDA regulations state that Distributed by or Manufactured for is acceptable.
60601-1 states the name of the manufacturer / trademark / contact information must be on the label.
Does FDA or 60601 take precedence for private branded products?
Thank you for any explanation you can provide -
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