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Technology / Premarket approval / Federal Food / Drug / and Cosmetic Act / Medical device / Center for Devices and Radiological Health / Humanitarian Device Exemption / Clinical trial / Substantial equivalence / Investigational Device Exemption / Food and Drug Administration / Medicine / Health


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City

Rockville / /

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IndustryTerm

energy source / diagnostic devices / predicate devices / predicate device / preamendments device / clinical management / particular device / diagnostic and therapeutic devices / Web site addresses / treatment of the disease / marketed device / /

MedicalCondition

disease / probable injury / injury / specific disease / future disease / illness / /

Organization

Radiological Health Center for Biologics Evaluation and Research Contains Nonbinding Recommendations Draft / office of Communication / Outreach and Development / Food and Drug Administration / Division of Dockets Management / Food and Drug Administration Center for Devices / Department of Health and Human Services / Center for Biologics Evaluation and Research / /

Person

Silver Spring / /

/

Position

Governor / Commissioner / Director of the Center / Secretary / /

ProvinceOrState

Maryland / /

URL

http /

SocialTag