Medical devices and the public's health : the FDA 510(k) clearance process at 35 years / Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process, Board on Population Health and Public Health Practice, Institute of Medicine of the National Academies.
"Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective device...
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| Other title: | FDA 510(k) clearance process at 35 years Food and Drug Administration 510(k) clearance process at 35 years |
| Format: | Electronic eBook |
| Language: | English |
| Published: |
Washington, D.C. :
National Academies Press,
©2011.
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| Subjects: |
Table of Contents:
- Introduction
- Key medical-device legislative and regulatory actions
- Components of US medical-device regulation
- The 510(k) clearance process
- Postmarketing surveillance, compliance, and enforcement
- External factors that affect the medical-device regulatory system
- Conclusions and recommendations
- A history of medical-device legislation and regulation in the United States.