On Wed, 11 Jun 2003 10:54:36 +0200,
  Kim Boll Jensen <k...@bolls.dk> wrote:

> 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.

I would suggest to refer to the Laser Notice No.42 issued from CDRH, at:

  http://www.fda.gov/cdrh/radhlth/pdf/laser-notice-42.pdf

Which is titled "Clarification of compliance requirements for certain
manufacturers who incorporate certified Class I laser products into
their products", and describes possible reduction of the requirements
under certain conditions.

Regards,
Tom


Tomonori Sato  <vef00...@nifty.ne.jp>
URL: http://member.nifty.ne.jp/tsato/


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