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Technology / Premarket approval / Center for Devices and Radiological Health / Medical device / Cost–benefit analysis / Federal Food /  Drug /  and Cosmetic Act / Regulatory Flexibility Act / Modification and Replacement Parts Association / Food and Drug Administration / Medicine / Health


Microsoft Word - FDA2012N0159RIA.doc
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City

Nucleic Acid / /

Company

Eastern Research Group Inc. / /

Country

United States / /

Currency

USD / /

Event

FDA Phase / /

IndustryTerm

healthcare workers / similar medical device products / similar device / device / pre-market manufacturing site / devices / manufacturing / nucleic acid-based in vitro diagnostic devices / /

NaturalFeature

Dale R. / /

Organization

FDA’s Center for Devices / Submission Annual Reports Subtotal Government / U. S. Department of Commerce / Radiological Health / FDA / Policy and Planning Office / U.S. Bureau / Bureau of Economic Analysis / Small Business Administration / Planning office of Policy / DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Microbiology Devices / FDA’s Center for Devices and Radiological Health / /

Person

Blozan / Steven A. Tucker / /

Position

investigator / Official / Commissioner / Executive / Private Sector / /

Product

PMA supplement / /

PublishedMedium

Public Law / /

Technology

Diagnostic Tests / pdf / /

URL

http /

SocialTag