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Mod6_pt6_MD_PostMarketCompliance - Medical Devices Post...

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12/3/2009 1 Medical Devices Post Market Compliance David W. Mullis, Jr., Ph.D., RAC PHAR 6010 Post Market Compliance • Determined by Class of Device Class I Class II Class III • Determined by regulatory pathway 510(k) PMA PDP 2 Post Market Compliance All devices must comply with: General Controls Medical Device Reporting Class II must comply with: General Controls Special Controls (Mandatory and Voluntary) Standards Medical Device Reporting Class III must comply with: General Controls Standards Medical Device Reporting Special Conditions of Approval Post Approval Study Tracking 3
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12/3/2009 2 Medical Device Reporting • Goal of Medical Device Reporting (MDR) regulation is to send a signal to FDA and the manufacturer that a device presents a potential public safety problem, and that a corrective action may be needed. • Requirement to report added to the FD&C Act in 1990 because firms were conducting voluntary recalls without notifying FDA. 4 Medical Device Reporting • Information must be reviewed and evaluated to determine if it constitutes a “complaint,” defined as: “Any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of a device after it is released for distribution.” (21CFR803.3) 5 MDR Reportable Event • An event about which a manufacturer has received or “become aware” of information that reasonably suggests one of its marketed devices: May have “caused or contributed” to a death or “serious injury”; or Has “malfunctioned” in a way that, if the malfunction were to happen again, would likely cause or contribute to a death or serious injury.
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  • Spring '11
  • Mullis
  • Food and Drug Administration, medical device, Federal Food, Drug, and Cosmetic Act, Center for Devices and Radiological Health, Post Market Compliance

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Mod6_pt6_MD_PostMarketCompliance - Medical Devices Post...

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