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Hi all good people

Just a simple question.

When using a CD or DVD driver in a product (PC or audio product) and the
driver is FDA registered, do I need to register the final product at FDA
too. I can't find a paragraph in 21 CFR which tells me when not to
register.

(The drives are Class I but includes a higher laser internally as fare
as I know)


Best regards,


Kim Boll Jensen
Bolls Raadgivning
Denmark

Title: FDA registration of laser

Hi all good people

Just a simple question.

When using a CD or DVD driver in a product (PC or audio product) and the
driver is FDA registered, do I need to register the final product at FDA
too. I can't find a paragraph in 21 CFR which tells me when not to
register.

(The drives are Class I but includes a higher laser internally as fare
as I know)


Best regards,


Kim Boll Jensen
Bolls Raadgivning
Denmark

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