I was looking today too, until the site crashed.
I got as far as just about all laser's, LED types too, require a "report" to be
sent in and if found acceptable, you'll get a letter back with an "accession
number". That number gets used for US Customs. And there is a yearly report
update too.
But... I was looking for exemptions, and/or details of the reports.
-
Bill
--- On Mon, 7/26/10, Ron Pickard <rpick...@hypercom.com> wrote:
From: Ron Pickard <rpick...@hypercom.com>
Subject: FDA/CDRH filing query
To: "EMC-PSTC@LISTSERV.IEEE.ORG" <EMC-PSTC@LISTSERV.IEEE.ORG>
Date: Monday, July 26, 2010, 5:02 PM
Hello,
Hopefully, this will be a quick query here to those familiar with the
FDA/CDRH requirements for laser products.
There is some confusion with some colleagues about whether or not a
device needs to be submitted to the FDA/CDRH for approval when and even though
an FDA/CDRH approved Class II scan engine is integrated. However, I have
briefly read through the FDA/CDRH and CFR requirements in the past (FDA website
isn’t working right now so I can’t confirm) and am of the opinion that such
device approvals are indeed required with integrated Class II or higher laser
devices.
But as one not intimately familiar with this process, I thought it best
to present this question to the experts. Please advise.
I look forward to your replies.
Best regards,
Ron
-
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