Steve, both. The client has to file a yearly report as well. The client
just refers to the OEMs FDA Accession number along with detailing labeling,
manuals, etc.
Jim Bacher, WB8VSU
[email protected] or [email protected]
JBRC Consulting LLC
Product EMC & Regulatory Consultant
https://trc.guru/ email:[email protected]
IEEE Life Senior Member
On June 18, 2024 5:39:08 PM sgbrody <[email protected]> wrote:
I have a client with a product that has a 3rd party Class 3B laser embedded.
Who needs an FDA Accession number - laser manufacturer or my client as an
end product containing an embedded laser?
Thanks,
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