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Browsing by Author "Anderson, Randy"
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FDA Medical Device Warning Letters and Trends Pre and Post COVID 2013-2022
Anderson, Randy; Tan, Christabel (2023-11-08)The United States Food & Drug Administration requires under Title 21 of the Code of Federal Regulations (21 CFR) Part 820.100, that medical device manufacturers must establish a system to address Corrective And Preventive ... -
FDA Warning Letters, Consequences and Costs to the US Medical Device Industry
Anderson, Randy; Tan, Christabel (2023-11-11)To launch or keep a medical device on the US market, FDA pre-approval or continued approval is required. After product approval, the FDA routinely conducts surveillance inspections of medical device companies. The present ...