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Pharmaceutical sciences / Food and Drug Administration Modernization Act / Federal Food / Drug / and Cosmetic Act / Premarket approval / Center for Devices and Radiological Health / Substantial equivalence / Food and Drug Administration / Medicine / Health


The Least Burdensome Provisions of the FDA Modernization Act of 1997 Concept and Principles A Document Prepared by Representatives of The Least Burdensome Industry Task Force and FDA
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Country

United States / /

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IndustryTerm

device technologies / regulatory tools / device manufacturers / to all devices / predicate device / Manufacturing information / marketed device / /

MedicalCondition

deficiency / /

Organization

FDA / Food and Drug Administration / Least Burdensome Industry Task Force / /

Person

Joanne R. Less / Janet Trunzo / /

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Position

representative / General / /

Technology

device technologies / in vitro diagnostics / /

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