•
Quote:
|
If the manufacturer of the device is no longer in business, then it is the responsibility of the sunlamp product owner to apply the required labeling.
|
Are these labels going to essentially be pretty standard and available from our distributors???
The manufacturer of much of my equipment is out of business and not otherwise available to help me with the relabeling of my equipment. Is that going to be an issue with the FDA or do I just need to label??? I won't have to do any form 510 compliance crap myself, will I???
Are lamps purchased today or hereafter which have not been labelled or approved by the FDA (according to whatever the final compliance rules require) likely to become obsolete or, more specifically, a violation once the 450 days elapses???