FDA Regulation of Medical Devices

Format:

Book

Government document

Author/Creator:

Library of Congress. Congressional Research Service

Language:

English

Subjects (All):

Labels.

Manufactures.

Marketing.

Medical laws and legislation.

Physical Description:

1 online resource

Contained In:

ProQuest U.S. Congressional Research Digital Collection

Place of Publication:

[United States] [publisher not identified] 2012

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:

CRS Report

Record is based on bibliographic data in ProQuest U.S. Congressional Research Digital Collection (last viewed Apr. 2014). Reuse except for individual research requires license from ProQuest, LLC

Vendor supplied data

Other Format:

Microfiche version Library of Congress. Congressional Research Service. FDA Regulation of Medical Devices

Publisher Number:

CRS-2012-DSP-0287

Access Restriction:

Restricted for use by site license