Evaluate and consult Stanford Health Care Stanford California in their development and marketing of the Stanford Actionable Mutation Panel for Fusions

Evaluate and consult Stanford Health Care Stanford California in their development and marketing of the Stanford Actionable Mutation Panel for Fusions

Evaluate and consult Stanford Health Care, Stanford, California in their development and marketing of the Stanford Actionable Mutation Panel for Fusions, also called the Stanford FusionSTAMP.

Paper Context:

Research, Development, and Manufacturing

Post Product Lifecycle: Pre-Market & development to post-market support and regulation.
Company and Product Transparency: Product Safety. Disclosures related to safety and intended use. Does the product require a materials safety data sheet (MSDS) or any type of special protocols? Any specific standard operating procedure (SOP)?
Clinical trial requirement or need? Why or Why Not? If yes, what are the guidelines for compliance?
Does the company need to apply for an investigational device exemption? Will the FusionSTAMP need to be labeled for Research Only Use?
Manufacturing oversight and any manufacturing regulations?

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