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2 Key Medical-Device Legislative and Regulatory Actions
Pages 29-40

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From page 29...
... to carry out the directives of Congress has been constrained by chronically inadequate appropriations to the agency (FDA Science Board, 2007; GAO, 1983, 1989, 1992, 1995, 1996, 1997, 2009a; OTA, 1984) .1 In 2002 and 2007, Congress passed legislation that authorized the agency to charge the device industry user fees to expand premarket-review capacity.
From page 30...
... into three categories -- called Class I, Class II, and Class III -- on the basis of the definitions that Congress adopted. Thereafter, under the statute, a device type could be transferred from one class to another on the basis of new information showing that it would now be more appropriately assigned to a different class.
From page 31...
... or that creates a potential unreasonable risk of illness or injury and that cannot be placed into Class I or Class II, because the general controls are inadequate to give reasonable assurance of safety and effective ness and because there is not sufficient information to establish a performance standard to provide the requisite assurance.6 Congress directed that the safety and effectiveness of a device were to be determined with respect to the persons for whose use the device is intended, with respect to the conditions of use in the labeling of the device, and by "weighing any probable benefit to health from the use of the device against any probable risk of injury or illness from such use."7 The classification of preamendment devices did not include any evaluation of the safety or effectiveness of the individual medical devices. The FDA created advisory panels to assist in the device classification process.
From page 32...
... In other words, if the preamendment device had been placed into Class III, the substantially equivalent postamendment device would be in Class III and subject to PMA review when the FDA called for the PMA application for the preamendment device. If the preamendment device were placed into Class I or Class II, the substantially equivalent postamendment device would be permitted into the market subject to whatever controls or performance standards were applicable to the preamendment device.
From page 33...
... . Finally, the resource constraints delayed the promulgation of regulations calling for PMA applications for preamendment Class III devices and establishing performance standards for Class II devices.9 Until those two steps occurred, Class II and Class III devices were subject to the same standard for market entry as Class I devices: demonstration of substantial equivalence to a preamendment device.
From page 34...
... (As of April 2011, it was not finished.) For Class II devices, the new law addressed the FDA's failure to establish performance standards.
From page 35...
... decision made by the FDA creates a precedent that is legally binding on the agency unless it has rescinded the decision or has barred the device covered by that decision from the market through other legal actions. The relationship between the 510(k)
From page 36...
... If, despite the change in technologic characteristics, the new device was as safe and effective as the predicate, it would be found to be substantially equivalent. About 15% of Class II and Class III 510(k)
From page 37...
... notifications for most new Class I devices and some Class II devices to permit the FDA to concentrate its resources on higher-risk devices. The act imposed various constraints on the scope of review of 510(k)
From page 38...
... The legislation also limited the application of some postmarketing tools to Class II and Class III devices and eased reporting requirements for adverse medical events. Finding 2-6 The 510(k)
From page 39...
... SUMMARY OF FINDINGS • inding 2-1 The safety and effectiveness of individual preamend F ment Class II medical devices has not been systematically reviewed. Continued use in clinical practice, however, provides at least a level of confidence in the safety and effectiveness of preamendment Class II medical devices still on the market.
From page 40...
... User fees have increased the level of fund ing for premarket review activities but not other CDRH operations. The 5-year term of the user-fee program and the risk that it might lapse if various conditions are not met do not ensure stability.


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