For initial certification of a laser
product, the following must be true or must be performed:
· The product must meet the performance
standards for the appropriate class. 21 CFR, 1040.10 (f). Performance
features include devices such as protective housing, key switches,
interlock systems, beam attenuator, labeling etc.
· “User documentation” (owner’s
manuals) must be generated or modified so as to reflect the informational
requirements of 1040.10 (h)
· An “Initial Product Report” must be
generated and filed with the CDRH. 1002.10 This is typically a 40-60 page
technical document for each different model.
· A certification test procedure shall
be generated and performed on each unit being certified 1010.2 (c)
After initial certification there are
additional compliance requirements such as record keeping and filing of
annual reports, 1002.13. You also need to be aware of the details about
how to process, import and export units as well as other items.
Additionally, in many cases, dealers or distributors may have record
keeping and reporting responsibilities.