Unique Device Identification

Results: 463



#Item
331Pharmaceutical sciences / Clinical pharmacology / Pharmacology / Therapeutics / United States Public Health Service / Unique Device Identification / Medical device / Medicine / Food and Drug Administration / Health

1 Addendum to the Preliminary Regulatory Impact Analysis of the Proposed Rule to Require a Unique Device Identification System Docket No. FDA-2011-N-0090 Section 519(f) of the Federal Food, Drug, and Cosmetic Act requir

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Source URL: www.fda.gov

Language: English
332Health / Technology / Medical device / Identifier / Medicine / Food and Drug Administration / Unique Device Identification

Identifying Real-world Human Factors Issues

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333Technology / Unique Device Identification / Center for Devices and Radiological Health / Medical device / Premarket approval / Adverse event / Food and Drug Administration / Medicine / Health

Introduction to the Unique Device Identification System December 18, 2013 Anne T. Hawthorn, JD FDA\CDRH\OSB\Informatics Staff

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Language: English
334Technology / Premarket approval / Medical device / Prescription Drug User Fee Act / Investigational Device Exemption / Structured Product Labeling / Unique Device Identification / Food and Drug Administration / Medicine / Health

[removed]Federal Register / Vol. 79, No[removed]Thursday, May 29, [removed]Notices to meet current standards, the Agency will advise ANDA applicants to submit

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Source URL: www.gpo.gov

Language: English - Date: 2014-05-29 06:03:01
335Technology / Federal Food /  Drug /  and Cosmetic Act / Unique Device Identification / Medical device / Center for Devices and Radiological Health / Food and Drug Administration / Medicine / Health

[removed]Federal Register / Vol. 79, No[removed]Wednesday, June 11, [removed]Notices Anyone with knowledge that any of the dates as published are incorrect may

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Source URL: www.gpo.gov

Language: English - Date: 2014-06-12 12:47:08
336Pharmaceutical sciences / Center for Devices and Radiological Health / Federal Food /  Drug /  and Cosmetic Act / Premarket approval / Title 21 of the Code of Federal Regulations / Humanitarian Device Exemption / Unique Device Identification / Food and Drug Administration / Medicine / Health

DEPARTMENT OF HEALTH&. HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate· Boulevard

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Source URL: www.accessdata.fda.gov

Language: English - Date: 2013-05-21 08:54:42
337Clinical research / Center for Devices and Radiological Health / Unique Device Identification / Food and Drug Administration / Pharmaceutical sciences / Health

[removed]Federal Register / Vol. 71, No[removed]Tuesday, July 25, [removed]Notices provide the broadest range of flexibility and choices to Federal agencies and end

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Source URL: www.fda.gov

Language: English - Date: 2006-07-25 07:59:16
338Technology / Medical device / Center for Devices and Radiological Health / Adverse event / MedWatch / Federal Food /  Drug /  and Cosmetic Act / Unique Device Identification / Food and Drug Administration Modernization Act / Food and Drug Administration / Medicine / Health

On July 9, 2013, the FDA issued a draft guidance titled, “Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Reporting for Manufacturers.” This draft guidance document describes and ex

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Language: English
339Technology / Unique Device Identification / Federal Food /  Drug /  and Cosmetic Act / Premarket approval / Medical device / Center for Devices and Radiological Health / Food and Drug Administration / Medicine / Health

Federal Register / Vol. 77, No[removed]Monday, November 19, [removed]Proposed Rules appropriate. If sending information directly to the International Branch, send it to ATTN: Dan Rodina, Aerospace Engineer, International Br

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Source URL: www.gpo.gov

Language: English - Date: 2012-11-17 02:55:15
340Pharmaceutical sciences / Medical device / Center for Devices and Radiological Health / Food and Drug Administration Amendments Act / Unique Device Identification / Food and Drug Administration / Medicine / Health

Federal Register / Vol. 73, No[removed]Thursday, May 22, [removed]Notices notify interested persons regarding their request to speak by June 10, 2008. Persons attending FDA’s advisory committee meetings are advised that t

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Source URL: www.fda.gov

Language: English - Date: 2008-05-22 08:20:45
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