2020
DOI: 10.25258/ijpqa.11.1.29 View full text |Buy / Rent full text
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Abstract: FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. Regulatory control increases from Class I to Class III. Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Pre-market Notification 510(k); and most Class III devices require Pre-market Approval.The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the De … Show more

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