What should manufacturers do if using alternate means without applying to and receiving approval from CDRH?
As is currently the case, manufacturers who use alternate means—whether they applied for and received approval for the alternate means from CDRH or based on this guidance–should document this in the product report and retain in-house the justification for use of alternate means for review upon CDRH request. If, in its review of a manufacturer’s product report, CDRH believes a particular laser product should have been labeled in accordance with the regulations, CDRH may notify the manufacturer and require recall of the product for relabeling or a change in the labeling in future production in accordance with 21 CFR 1003 and 1004. Manufacturers also may contact CDRH to discussion whether this guidance applies to their product. Please note, however, that CDRH does not act as an intermediary between manufacturers and testing laboratories from which the manufacturer may have sought independent certification of conformance.
Related Questions
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