FDA Regulation of Medical Devices [electronic resource].
- [S.l] : [s.n.], 2011.
- Government document
1 online resource (32 p., digital, PDF file)
- System Details:
- System requirements: PDF reader software.
- Describes FDA medical device review process, which is primarily carried out by the Center for Devices and Radiological Health. Examines premarket requirements, including device classification and medical device marketing applications; and reviews postmarket requirements, including labeling, manufacturing, postmarket surveillance, and compliance and enforcement.
- Record is based on bibliographic data in ProQuest U.S. Congressional Research Digital Collection (last viewed Jan. 2013). Reuse except for individual research requires license from ProQuest, LLC.
- Other format:
- Microfiche version: Library of Congress. Congressional Research Service. American Law Division. FDA Regulation of Medical Devices
- Access Restriction:
- Restricted for use by site license.
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