not reflect an FDA evaluation of the safety or effectiveness of either device.
• Finding 2-6 The 510(k) clearance process has evolved from 1976 to the present through administrative and legislative changes, narrowing the array of issues that the FDA may consider in a 510(k) review and limiting the type of evidence that the FDA could require. Over 35 years, there has been a high frequency of finding substantial equivalence.
• Finding 2-7 The gap in relative burdens on manufacturers between the 510(k) process and the PMA process created by the 1976 law has been maintained by administrative and legislative changes, which have encouraged preferential use of the 510(k) process.
• Finding 2-8 Congressional appropriations for operation of the 510(k) clearance process have been unstable and frequently inadequate throughout its 35-year life. User fees have increased the level of funding 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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_______. 2009b. FDA should take steps to ensure that high-risk device types are approved through the most stringent premarket review process (GAO-09-190). Washington, DC: Government Accountability Office.
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