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Biochem Pharmacol (2017) 134:11426
The following are key deliverables typically required within a 510(k) submission for medical devices: Cover letter Device description Indications for use Substantial equivalence discussion (predicate device comparison) Performance testing data (including clinical and non-clinical studies) Biocompatibility Software and firmware Manufacturing information (including declaration of conformity) Sterilization and packaging (including validation of devices sterility and integrity) Labeling Most class I and class II devices are exempt from 510(k) requirements
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