Roger,
Go to:
http://www.fda.gov/cdrh/qsr/contnt.html
Contract manufacturers are relieved of these requirements, i.e. FDA GMP.
Rick Howieson
Delta Group Electronics

-----Original Message-----
From: Roger Hammond [mailto:[log in to unmask]]
Sent: Monday, August 13, 2001 4:27 AM
To: [log in to unmask]
Subject: [TN] FDA approval


Dear Techneters,
                I work for a Printed Circuit Fabricator in the U.K.and one
of our
customers, a Printed Circuit Assembler has been approached by an OEM
that produces medical equipment. This OEM has FDA approval for his
product. The question is, is it the equipment that is FDA approved or
does it transfer down the line to the assembler and printed circuit
manufacturer in similar fashion to UL recognition. If it transfers down
the line how does one go about obtaining the approval.

Thank you  in advance

Roger Hammond

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