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Food law / Pharmaceuticals policy / Pharmacology / Pharmaceutical industry / Premarket approval / Medical device / Federal Food / Drug / and Cosmetic Act / Iontophoresis / Center for Devices and Radiological Health / Medicine / Food and Drug Administration / Health


[removed]Federal Register / Vol. 79, No[removed]Monday, September 22, [removed]Proposed Rules 11428, March 11, 2010); corrected May 4, [removed]FR 23572); are approved as AMOCs
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Document Date: 2014-10-07 13:13:58

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City

Philadelphia / Renton / Rockville / Charleston / /

Company

General Medical Co. / Airbus / Ethicon Inc. / /

Country

United States / /

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Event

FDA Phase / /

Facility

Arch Street / /

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IndustryTerm

ionic solution / non-sterile iontophoresis device / ionic solutions / on-line instructions / prescription devices / iontophoresis drug delivery systems / particular device / iontophoresis devices / non-drug solutions / acidic solution / drug delivery systems / classified preamendments devices / preamendments iontophoresis devices / combination products / preamendments devices / Appropriate software verification / medical devices / predicate device / excessive energy deposition / preamendments device / postamendments devices / medicine devices / considered iontophoresis devices / software verification / drug-device combination product / prescription device / combination product / iontophoresis device / non-drug solution / electrical equipment / /

MedicalCondition

sterility / burns to the skin / injury / burns / cardiac arrest / illness / electrical shock / Electric shock / inner ear injuries / Infection / contact dermatitis / hyperhidrosis / cystic fibrosis / pain / /

MedicalTreatment

drug delivery systems / /

Organization

EPA PO / Purposes AGENCY / office of Management and Budget / Division of Air Quality / Center for Devices and Radiological Health / Division of Dockets Management / FDA / Department of Health / FD&C Act / Federal Aviation Administration / Airworthiness Office / office of Air Program Planning / Transport Airplane Directorate / West Virginia Department of Environmental Protection / Air Protection Division / Center for Devices / DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration / Federal government / Center for Drug Evaluation and Research / Environmental Protection Agency / Aircraft Certification Service / /

Person

C. Mail / Jeffrey E. Duven / Leslie Kux / Cristina Fernandez / William C. Early / Silver Spring / Michael Ryan / Ellen Schmitt / /

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Position

Manager / International Branch / ANM– 116 / Assistant Commissioner for Policy / Executive / Manager / Governor / Associate Director / Commissioner / Acting Regional Administrator / Region III / controller / /

Product

fentanyl / Federal Food / DSK5VPTVN1PROD / EASA Design Organization / Drug / 22SEP1 / appropriate drug / /

ProvinceOrState

West Virginia / Washington / West / Maryland / Pennsylvania / /

Region

West Virginia / /

Technology

encryption / drug delivery / http / /

URL

http /

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