Franklin

FDA Regulation of Medical Devices [electronic resource].

Author/Creator:
Library of Congress. Congressional Research Service. American Law Division.
Publication:
[S.l] : [s.n.], 2011.
Format/Description:
Government document
Book
1 online resource (32 p., digital, PDF file)
Subjects:
Labels.
Manufactures.
Marketing.
System Details:
System requirements: PDF reader software.
Summary:
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.
Notes:
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.
CRS Report.
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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