Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions

Title:
Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions

https://www.gmp-compliance.org/files/guidemgr/Factors-to-Consider-Regarding-Benefit-Risk-in-Medical-Device-Product-Availability.pdf

Origin/Publisher:

FDA

Document Type:
Guidance
Content:
FDA has developed this guidance document to provide clarity for FDA staff and industry regarding the benefit and risk factors FDA may consider in prioritizing resources for compliance and enforcement efforts to maximize medical device quality1 and patient safety.

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