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This document is intended to provide guidance. It represents the Agency's
current thinking on the above. It does not create or confer any rights for or
on any person and does not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the requirements of the applicable
statute, regulations, or both.
http://www.fda.gov/cdrh/mdufma/guidance/108.html
Updated 3/20/1998
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Center for Devices and Radiological Health / CDRH