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Investigational Device Exemption
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#	Item
81	Microsoft Word - Order for Preliminary Injunction.docx Add to Reading List Source URL: www.justice.gov Language: English - Date: 2015-01-16 14:50:21 Health Federal Food Drug and Cosmetic Act Premarket approval Federal Rules of Civil Procedure Notice of electronic filing Pro se legal representation in the United States Investigational Device Exemption Food and Drug Administration Medicine Pharmaceutical sciences
82	[removed]Strategic Priorities Add to Reading List Source URL: www.fda.gov Language: English Health Clinical research Center for Devices and Radiological Health Pharmacology Pharmaceutical industry Premarket approval Medical device Investigational Device Exemption Medicine Food and Drug Administration Technology
83	Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies Guidance for Industry and Food Add to Reading List Source URL: www.fda.gov Language: English Medicine Pharmaceutical industry Pharmacology Evaluation methods Design of experiments Investigational Device Exemption Clinical trial Proof of concept Food and Drug Administration Clinical research Research Science
84	TKELLEY on DSK3SPTVN1PROD with PROPOSALS Federal Register / Vol. 79, No[removed]Wednesday, November 12, [removed]Proposed Rules providing an incentive for entities to remit their assessments in a timely manner, with the in Add to Reading List Source URL: www.gpo.gov Language: English - Date: 2014-11-11 18:09:20 Premarket approval Spondylolisthesis Federal Food Drug and Cosmetic Act Investigational Device Exemption Spinal fusion Center for Devices and Radiological Health Medical device Scoliosis Spinal stenosis Medicine Health Food and Drug Administration
85	FDA Regulatory Process Michael J. Hoffmann, M.S. Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Food and Drug Administration Add to Reading List Source URL: www.fda.gov Language: English Health Pharmacology Pharmaceutical industry Food and Drug Administration Investigational Device Exemption Center for Devices and Radiological Health Medical device Risk Clinical trial Medicine Clinical research Research
86	Monthly Newsletter - Pharma & Healthcare August 2014 Ingenious e-Brain Brain Solutions Add to Reading List Source URL: www.ingeniousebrainsolutions.com Language: English - Date: 2014-10-14 08:19:00 Food and Drug Administration Pharmaceutical industry Pharmacology Clinical research Medical equipment Unique Device Identification Medical device Investigational Device Exemption Drug recall Medicine Pharmaceutical sciences Health
87	Mandatory Reporting of Clinical Trial Identifier Numbers on Claims Q: A: Do organizations bill Medicare for all services related to the clinical trial and then bill Add to Reading List Source URL: accrualnet.cancer.gov Language: English - Date: 2014-03-12 10:16:19 Clinical trials Health ClinicalTrials.gov Medicare Investigational Device Exemption Pharmaceutical industry Clinical research Research
88	Agenda for Quarterly Meeting on MDUFA III (FY[removed]Performance November 18, [removed]:00 A.M. Welcome. Barbara Zimmerman, CDRH-ODE. Guidance Development • Add to Reading List Source URL: www.fda.gov Language: English Health Premarket approval Investigational Device Exemption Center for Devices and Radiological Health Medical device Humanitarian Device Exemption Unique Device Identification Food and Drug Administration Medicine Technology
89	Questions for CDRH Ophthalmic Advisory Panel 1. In light of the 715 protocol deviations and ambiguity surrounding the use of terminology for intraocular lens (IOL) misalignment and rotation, do you believe that the data Add to Reading List Source URL: www.fda.gov Language: English Health Clinical pharmacology Pharmacology Therapeutics United States Public Health Service Intraocular lens Center for Devices and Radiological Health Investigational Device Exemption Food and Drug Administration Medicine Pharmaceutical sciences
90	FDA Executive Summary Prepared for the October 9, 2013 meeting of the Circulatory Systems Devices Panel P100045/A004 CardioMEMS Champion™ HF Monitoring System Add to Reading List Source URL: www.fda.gov Language: English Clinical research Pharmaceutical industry Medical equipment Implants Clinical trial Port Food and Drug Administration Medical grade silicone Investigational Device Exemption Medicine Health Pharmacology

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