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Food and Drug Administration / Healthcare quality / Actuarial science / Medical terminology / Pharmaceuticals policy / Risk management / Medical device / Federal Food / Drug / and Cosmetic Act / Center for Devices and Radiological Health / Patient safety / Investigational device exemption / Adverse effect


Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions - Draft Guidance for Industry and Food and Drug Administration Staff
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