Group,
In one of our products we use a certified laser transmitter. The unit is
class 1, is internally protected so it cannot exceed this limit and it has an
FDA ascession number i.e. a report on the product is filed with the FDA.
The other day whilst searching the FDA website I found laser notice number 42
which states that 'the CDRH will consider firms incorperating certified class 1
laser products into another product as distributors of laser products certified
and reported by other manufacturers.' It goes on to give some conditions, mostly
regarding the labeling. Earlier on in the same document examples of such
situations were given as 'disc drive units incorperated into computers, CD
players installed into home entertainment centres and CD players installed into
automobiles'
The laser we use is in a drop in DIL package and is an approved laser product in
its own right. The main question is how applicable is this? In words it would
seem that we are 'incorperating a certified class 1 laser product' but there is
a big difference between a CD player as a hi fi seperate and a CD player as a
component module that is then built into a Hi Fi seperate. The main difference
being that the seperate is a 'laser system' i.e. it has a power supply and the
CD module is not and therefore cannot be used unless it is installed in another
unit. The car CD player or the PC CD ROM would also need to be installed before
they could be used.
The main question here is does the relaxation in the CRDH laser reporting
requirements for incorperated certified class 1 laser products cover 'laser
systems' laser components or both?
Many thanks in advance,
Duncan.
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