Jeff Haney wrote:
> Dear Treggers:
> I have a product which needs to be tested for conformance with FDA
> regulations regarding laser products. Has anybody had any experience
> with this and, if so, can you recommend any test labs?
> On the same subject, is there any feel out there for what frequency of
> production testing is acceptable to the FDA for these products?
> Thanks in advance-
> Jeff Haney ([email protected])
Yes.
There is no "testing" to speak of.
You declare compliance to:
United States: Title 21, Parts 1000, 1010, 1040 (nicknamed 'The Laser Law')
Enforced by the FDA - Food and Drug Administration.
You do this by filling out a very lengthy 30 page declaration.
The declaration is constructed from a brief that you can get from
DIRECTOR
FOOD AND DRUG ADMINISTRATION
NON-MEDICAL RADIOLOGICAL DEVICES BRANCH
OFFICE OF COMPLIANCE (HFZ-342)
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
2098 GAITHER ROAD
ROCKVILLE, MD 20850
Stay away from interlocks!
Construct the device so it is impossible to look into
the connector (not the fiber). Then, you can declare
your product as a Class I device even though you may
be using a Class III-b laser system inside your product.
Definitions:
Laser System = the laser device in your product.
Laser Product = your product that uses a laser.
Send: 1. Your declaration (that includes all laser info)
2. All product information,
3. Any drawings showing how compliance is met,
by Registered mail.
The date you send is recognized by the FDA as your
registration date with them.
You will recieve a letter (maybe months later) stating the FDA has
recieved your and is reviewing it. The letter also states that
the FDA is in no way stating approval of what you're doing
by sending you the letter. Keep the registered mail receipt,
all product info, and letter on file. Moving to another laser
class means going through the whole thing all over.
Although this has been but a brief description of the process,
the specific appication to your product will vary.
Recently, there was an excellent article in Compliance Engineering
on the subject.
Hope this helps.
Doug
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Doug McKean
[email protected]
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The comments and opinions stated herein are mine alone,
and do not reflect those of my employer.
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