Thanks to those who responded to my question.Sent from my T-Mobile 5G Device
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Hello all,
The manufacturer of the end-use product must ALSO submit an application to
the CDRH (as a LASER PRODUCT) when they are incorporating an existing OEM
laser or laser system that has a CDRH accession # associated with it.
This manufacturer will then get a different accession # on this new
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
j.bac...@ieee.org or ja.bac...@outlook.com
JBRC Consulting LLC
Product EMC & Regulatory Consultant
Have you asked the laser maker? Surely they know fur certain.
On 2024-06-18 22:38, sgbrody 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?
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,Sent from my T-Mobile 5G Device
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