Get FDA 3654 2010
Nclude: any adaptations used to adapt to the device under review (for example, alternative test methods); choices made when options or a selection of methods are described; deviations from the standard; requirements not applicable to the device; and the name and address of the test laboratory or The supplemental information sheet (SIS) is additional information which is necessary before FDA recognizes the standard. Found at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/ search.c.
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