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Accession Number PB2014-100140
Title FDA's Clearance of Medical Devices Through the 510(K) Process.
Publication Date Sep 2013
Media Count 31p
Personal Author N/A
Abstract The Food and Drug Administrations (FDA) premarket notification (i.e., 510(k)) process is a faster and less stringent method to obtain clearance to market medical devices than the Premarket Approval (PMA) process. FDA is required to classify devices by the level of control needed to provide reasonable assurance of device safety and effectiveness (i.e., Class I, II, or III). Most Class III devices must be approved through the PMA process, although some continue to be cleared through the 510(k) process using regulatory categories of devices (Class III preamendment device types). The Safe Medical Devices Act of 1990 requires FDA to either reclassify Class III preamendment device types as Class II or I or keep them as Class III and require a PMA review.
Keywords Classification
Data collection
Food and Drug Administration(FDA)
Health care
Medical devices

Source Agency Department of Health and Human Services, Washington, DC
NTIS Subject Category 95A - Prosthetics & Mechanical Organs
44Q - Health Related Costs
44K - Health Services
57X - Surgery
Corporate Author Department of Health and Human Services, Washington, DC. Office of the Inspector General.
Document Type Technical report
Title Note N/A
NTIS Issue Number 1401
Contract Number N/A

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