Medical Devices and the Public's Health The FDA 510(k) Clearance Process at 35 Years (2011) / Chapter Skim
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7 Conclusions and Recommendations
7 Conclusions and Recommendations
Pages 189-206
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From page 189... ...
(The 510(k) clearance process is an integrated component of the larger medical-device regulatory framework.
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From page 190... ...
PROTECTING THE PUBLIC'S HEALTH BY ENSURING THE SAFETY AND EFFECTIVENESS OF MEDICAL DEVICES To assess whether the 510(k) clearance process is protecting the public's health by providing reasonable assurance that marketed Class II medical devices are safe and effective, the committee explored two avenues.
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From page 191... ...
. Under the Safe Medical Devices Act of 1990, the FDA is permitted to require evidence of safety and effectiveness, including clinical studies, when it is necessary for determining whether a difference in technologic characteristics between a new device and its predicate renders the new device less safe or effective than the predicate or raises different questions of safety and effectiveness from the predicate.
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The committee also recognizes that mass-media reports of problematic medical devices that were cleared through the 510(k) clearance process do not necessarily represent generalizable evidence about the soundness of the entire 510(k)
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The committee agreed on a definition of innovation to assess whether the current 510(k) clearance process optimally protects patients and promotes innovation in support of public health.
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clearance process offers a less burdensome pathway to market, the increasing complexity of devices is challenging the capabilities of this process (Findings 6-1, 6-2, 6-3, and 6-4)
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From page 195... ...
The committee believes that although the regulatory process can facilitate innovation that improves public health by making safe and effective Class II medical devices available to consumers in a timely manner, the FDA should not be the arbitrator of what constitutes innovation, nor should it seek to channel device development and premarket review toward agencydetermined public-health priorities. In the committee's opinion, the FDA's
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From page 196... ...
Recommendation 7-1 The Food and Drug Administration should obtain adequate information to inform the design of a new medical device regulatory framework for Class II devices so that the current 510(k) process, in which the standard for clearance is substantial equivalence to previously cleared devices, can be replaced with an integrated premarket and postmarket regulatory framework that effectively provides a reasonable assurance of safety and effective ness throughout the device life cycle.
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. The committee urges the FDA to create a regulatory framework that more closely matches the ideal regulatory framework outlined by the committee in Chapter 1.
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Postmarketing Surveillance As stated repeatedly in the report, the 510(k) clearance process is not a stand-alone program but a component of the larger medical-device regulatory framework.
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As discussed in Chapter 5 of this report, the committee found that there was no long-term strategy in the FDA to address the effectiveness of medical-device postmarketing surveillance. The committee recommends that the FDA develop a postmarketing surveillance strategy to meet the following objectives: provide performance information for use in the premarket review process, inform the development and use of postmarketing tools (that is, general and special controls)
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Recommendation 7-3 The Food and Drug Administration should review its postmarket regulatory authorities for medical devices to identify existing limitations on their use and to determine how the limitations can be addressed. The appropriate use of postmarket regulatory authorities is an essential component of a successful medical-device regulatory program.
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From page 201... ...
The agency also should consider expanded use of external expertise and preinvestigational device exemption meetings with submitters and use of conditional clearances for devices on which there is little premarket performance information (such as a clearance conditioned on postmarketing surveillance or use of registries)
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By developing a business model grounded in continuous quality-improvement, CDRH will be able to identify problems and develop the information and capacity to address them in a data-driven, transparent manner. Facilitating Innovation in the Medical-Device Industry As stated above, the committee believes that the FDA's role in facilitating innovation with respect to Class II devices is to create and enforce a regulatory framework where the threshold to market provides reasonable assurance that medical devices are safe and effective throughout their life cycle while permitting timely entry of new devices that may offer improvements over already marketed devices.
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, the integration in medical devices of commercial software not intended for use in them, the increasing uncertainty introduced by device complexity, and potentially unsafe interactions with other software systems. Reliance on "best practices" is no longer sufficient, particularly when best-practice recommendations often lag behind rapid change in software innovation.
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From page 204... ...
-Eligible Class III Devices After 35 years, the FDA has not completed the task of calling for PMAs for or reclassifying preamendment Class III device types. Until the FDA completes that task, those devices are allowed to enter the market through the 510(k)
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From page 205... ...
Senate. Medical devices: FDA's premarket review and postmarket safety efforts (GAO-11-556T)
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