Medical Devices and the Public's Health The FDA 510(k) Clearance Process at 35 Years (2011) / Chapter Skim
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notification that it was "substantially equivalent" to a "preamendment" device and, for Class II devices, complied with the applicable performance standard promulgated by the FDA. If the new device were substantially equivalent, it would be classified in the same class, and cleared for marketing subject to the same terms and conditions, as that preamendment device (for example, conformance to a performance standard)
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The Safe Medical Devices Act (SMDA) of 1990 permitted substantial equivalence to be established to marketed postamendment, in addition to preamendment, "predicate" devices, except for devices approved by PMA.
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, in addition to performance standards.1 The Food and Drug Administration Modernization Act of 1997 eliminated the requirement for 510(k) clearance for most Class I and some Class II device types, narrowed the array of issues that the FDA may consider in a 510(k)
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. Because the FDA has not promulgated performance standards or special controls for the vast majority of types of Class II devices, and because when a special control applies it does not necessarily apply to all aspects or components of the device, the basis for market entry for Class II devices has been (and remains)
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By law, the standard for classification and clearance is substantial equivalence to any predicate device already in Class II. The assessment of substantial equivalence does not require an independent demonstration that the new device provides a "reasonable assurance of safety and effectiveness," as the statute requires for PMAs for new Class III devices.
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The committee does not believe, however, that there is a public-health crisis related to unsafe or ineffective medical devices. Although the safety and effectiveness of individual preamendment Class II devices have not been systematically reviewed, their continued use in clinical practice provides at least a level of confidence in their safety and effectiveness.
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The FDA's role in facilitating innovation in Class II medical devices through premarket review should be to create a regulatory framework that sets appropriate thresholds for bringing products to the market. Those thresholds should be stringent enough to satisfy the agency's objective of ensuring that marketed medical devices will be safe and effective throughout their life cycles but realistic enough to permit timely entry of new devices that may offer improvements over already marketed devices.
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Designing a New Medical-Device Regulatory Framework 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 found substantial weakness in postmarketing surveillance of medical devices. The inadequate postmarketing surveillance systems, both those in the FDA and those that are privately funded, and the resulting lack of useful, consistent, and reliable data make it impossible to
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The FDA should develop a postmarketing surveillance strategy to meet the following objectives: providing performance information for use in the premarket review process, informing the development and use of postmarketing tools (that is, general and special controls2) to better manage the risk-benefit ratio throughout the life cycle of devices, and informing the design of a new regulatory framework.
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Recommendation 7-4 The Food and Drug Administration should investigate the viability of a modified de novo process as a mecha nism for evaluating the safety and effectiveness of Class II devices. A pilot program of a modified de novo process would allow the FDA to determine its feasibility as a replacement for the 510(k)
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By developing a business model grounded in continuous quality-improvement, the FDA will be better able to identify problems with devices and develop the information and capacity to address them in a data-driven, transparent manner. Facilitating Innovation in the Medical-Device Industry The FDA's role in facilitating innovation with respect to Class II devices is to create and enforce a regulatory framework for which 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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-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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