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.

REFERENCES

FDA (Food and Drug Administration). 2010. CDRH preliminary internal evaluations—Volume I: 510(k) working group preliminary report and recommendations. Silver Spring, MD: Food and Drug Administration.

FDA Science Board. 2007. FDA science and mission at risk: Report of the subcommittee on science and technology. Silver Spring, MD: Food and Drug Administration.

GAO (Government Accountability Office). 1983. Federal regulation of medical devices—problems still to be overcome (HRD-83-53). Washington, DC: General Accounting Office.

_______. 1989. FDA resources: Comprehensive assessment of staffing, facilities, and equipment needed (HRD-89-142). Washington, DC: General Accounting Office.

_______. 1992. FDA regulations: Sustained management attention needed to improve timely issuance (T-HRD-92-19). Washington, DC: General Accounting Office.

_______. 1995. Medical devices: FDA review time (PEMD-96-2). Washington, DC: General Accounting Office.

_______. 1996. FDA resources (PEMD-96-8R). Washington, DC: General Accounting Office.

_______. 1997. Medical devices: FDA review times, 1989 through 1996 (HEHS-97-146R). Washington, DC: General Accounting Office.

_______. 2009a. FDA faces challenges meeting its growing medical product responsibilities and should develop complete estimates of its resource needs (GAO-09-581). Washington, DC: Government Accountability Office.

_______. 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.

IOM (Institute of Medicine). 2010. Public health effectiveness of the FDA 510(k) clearance process: Balancing patient safety and innovation. Washington, DC: The National Academies Press.

OTA (Office of Technology Assessment). 1984. Federal policies and the medical devices industry. Washington, DC: Congress of the United States, Office of Technology Assessment.



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement