Class III Device

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Class III Device

A highly-regulated ‘high risk’ medical device—e.g., pacemakers and heart valves—approved by the FDA for use in humans

class III device

Regulatory affairs A highly regulated 'high risk' medical device–eg, life-support or life-sustaining devices–eg, pacemakers and heart valves, approved by the FDA for use in humans; CIIIDs are also defined as those which pose a potentially unreasonable risk of illness or injury. See Medical device.

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premarket approval			Although Congress envisioned that class III devices would be approved through the more stringent PMA process, and the Safe Medical Devices Act of 1990 required that FDA either reclassify or establish a schedule for requiring PMAs for class III device types, this process remains incomplete. Medical Devices: FDA Should Take Steps to Ensure That High-Risk ... by General Accounting Office Reports & Testimony Class III devices generally must obtain a PMA, but, according to the GAO, until FDA issues regulations requiring submission of PMAs, certain types of Class III devices may be cleared via the 510(k) process. FDA device evaluation begins 2009 under fire: spine society now ... by Orthopedic Design & Technology The hearing aid is considered a Class III device by the FDA--the most stringent regulatory category for devices. FDA seeks civil penalties from device maker by Adverse Event Reporting News			Claritin Clark clamp Clark's level Clark's rule Clark's weight rule Clarke-Hadfield syndrome clary CLAS clasmat- clasmatocyte clasp clasp arm Clasp Knife Phenomenon clasp torsion clasp-knife reflex clasp-knife release clasp-knife spasticity class Class Action Lawsuit Class Device Class I Device Class I Recall class II biologic safety cabinet Class II Device Class II Recall Class III Device Class III Recall Class Recall class switching classic classic cesarean section classic complement pathway classic hemophilia classic migraine classic tomography classic typhus classic visceral leishmaniasis classical classical conditioning Classical incision classical Western massage classification classification of caries classification of malocclusion classification schemes classify classing clastic clastogenic clastothrix clathrate			class Hyalospongiae class Hydrozoa class Hymenomycetes Class I class I a class I a class I a class I antigens class I antigens class I antigens class I device Class I Major Histocompatibility Complex Class I Ozone Depleting Substance Class I Recall Class Identifier Class II Class II class II a class II a class II a class II antigens class II antigens class II antigens class II biologic safety cabinet class II device class II invariant chain peptide Class II Recall Class II-associated invariant chain peptide Class II-associated invariant chain peptide Class III Class III Device Class III Recall Class Improvement Plan Class Improvement Program class Insecta Class interest Class interest Class interests Class interests Class Interface Size class interval class interval class intervals class intervals Class IX Study Class Justification & Approval class Lamellibranchia class Larvacea Class library Class Library for High Energy Physics Class Library for Image Processing Class Library for Numbers Class Life Class Life Asset Depreciation Range Class Life Asset Depreciation Range class Liliopsida class limits class limits class limits class limits class limits

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