CC
2007-06-29 20:02:46 UTC
Hi:
I have an interest to obtain a Chinese made laser for personal laser
show hobby use. I've been trying to understand what I must do, or if it
is even within my means, to ensure that if I obtain such a laser, it
will be legal.
According to the "Frequently Asked Questions for Manufacturers of
Electronic Products that Emit Radiation" located here:
http://www.fda.gov/cdrh/radhealth/rademitfaq.html
1. An importer of a laser would be considered a manufacturer, thus must
comply with the regs.
2. Must fill out form FDA 2877 to import a product.
The form has a section allowing one to declare that the product(s):
__ A. ARE NOT SUBJECT TO RADIATION PERFORMANCE STANDARDS BECAUSE THEY:
__ 5. Are components or subassemblies to be used in manufacturing or as
replacement parts (NOT APPLICABLE to diagnostic x-ray parts).
__ 6. Are prototypes intended for on going product development by the
importing firm, are labeled "FOR TEST/EVALUATION ONLY," and will be
exported, destroyed, or held for future testing (i.e., not distributed).
(Quantities Limited - see reverse.)
On the back it says:
DECLARATION A: Importers should be prepared to demonstrate compliance to
or non-applicability of FDA standards, regulations, or guidance.
Components or sub-assemblies must be non-functioning.[snip]
If one declares section A subsection 5, that the item is a component,
then one might have to demonstrate that the item is non-functioning.
What does this mean? It would seem unlikely that a Chinese laser which
requires only that one insert the power cord and turn it on could be
considered "non-functioning". Thus, this presents a stumbling-block to
the option of declaring the laser to be a component.
If one cannot declare the product to be a component and thus not subject
to FDA standards, then one is subject to the much more complex
requirements of declaring certification, filing reports, etc.
Every time I attempt to understand how to comply with government
regulations, the result is the same. It is simply overwhelming for a
single person. It requires the resources of a company which can afford
to dedicate specific personnel to the task of regulatory compliance, or
to hire a consultant firm to perform this task.
Hence the motivation to skirt the law is intense. No wonder there is a
thriving black market in non-compliant laser products sold by one-man
"sites".
Ugh.
I have an interest to obtain a Chinese made laser for personal laser
show hobby use. I've been trying to understand what I must do, or if it
is even within my means, to ensure that if I obtain such a laser, it
will be legal.
According to the "Frequently Asked Questions for Manufacturers of
Electronic Products that Emit Radiation" located here:
http://www.fda.gov/cdrh/radhealth/rademitfaq.html
1. An importer of a laser would be considered a manufacturer, thus must
comply with the regs.
2. Must fill out form FDA 2877 to import a product.
The form has a section allowing one to declare that the product(s):
__ A. ARE NOT SUBJECT TO RADIATION PERFORMANCE STANDARDS BECAUSE THEY:
__ 5. Are components or subassemblies to be used in manufacturing or as
replacement parts (NOT APPLICABLE to diagnostic x-ray parts).
__ 6. Are prototypes intended for on going product development by the
importing firm, are labeled "FOR TEST/EVALUATION ONLY," and will be
exported, destroyed, or held for future testing (i.e., not distributed).
(Quantities Limited - see reverse.)
On the back it says:
DECLARATION A: Importers should be prepared to demonstrate compliance to
or non-applicability of FDA standards, regulations, or guidance.
Components or sub-assemblies must be non-functioning.[snip]
If one declares section A subsection 5, that the item is a component,
then one might have to demonstrate that the item is non-functioning.
What does this mean? It would seem unlikely that a Chinese laser which
requires only that one insert the power cord and turn it on could be
considered "non-functioning". Thus, this presents a stumbling-block to
the option of declaring the laser to be a component.
If one cannot declare the product to be a component and thus not subject
to FDA standards, then one is subject to the much more complex
requirements of declaring certification, filing reports, etc.
Every time I attempt to understand how to comply with government
regulations, the result is the same. It is simply overwhelming for a
single person. It requires the resources of a company which can afford
to dedicate specific personnel to the task of regulatory compliance, or
to hire a consultant firm to perform this task.
Hence the motivation to skirt the law is intense. No wonder there is a
thriving black market in non-compliant laser products sold by one-man
"sites".
Ugh.
--
_____________________
Christopher R. Carlen
***@bogus-remove-me.sbcglobal.net
SuSE 9.1 Linux 2.6.5
_____________________
Christopher R. Carlen
***@bogus-remove-me.sbcglobal.net
SuSE 9.1 Linux 2.6.5