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Investigational Device Exemption
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11	Contact Information: Jon J. Snyder, President and CEO Neuros Medical, IncBLOK-7515 Add to Reading List Source URL: www.neurosmedical.com Language: English - Date: 2013-10-10 09:31:58 Neuros Technology Medical equipment Investigational Device Exemption Pain management Food and Drug Administration Chronic pain Medical device Medicine Pain Nociception
12	Federal Register / Vol. 80, NoMonday, May 18, Notices CDER anticipates providing four additional years of support up to the following amounts: absolutely essential element for ICH Add to Reading List Source URL: www.gpo.gov Language: English - Date: 2015-05-16 00:54:16 Research Health Pharmaceutical industry Drug safety Pharmacology Investigational New Drug Clinical trial Medical device Investigational Device Exemption Medicine Food and Drug Administration Clinical research
13	Draft Guidance for Industry and Food and Drug Administration Staff Adaptive Designs for Medical Device Clinical Studies DRAFT GUIDANCE Add to Reading List Source URL: www.fda.gov Language: English Design of experiments Medicine Medical statistics Pharmaceutical industry Pharmacology Investigational Device Exemption Clinical trial Randomized controlled trial Clinical study design Science Clinical research Research
14	CLEAN version with no appendices Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Pharmaceutical sciences Pharmaceutical industry Clinical pharmacology United States Public Health Service Medical device Expanded access Premarket approval Investigational Device Exemption Medicine Food and Drug Administration Health
15	Federal Register / Vol. 80, NoWednesday, May 27, Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA–2015–N–1072] Add to Reading List Source URL: www.gpo.gov Language: English - Date: 2015-05-27 10:33:02 Technology Pharmaceuticals policy Food law Pharmaceutical industry Premarket approval Clinical research Federal Food Drug and Cosmetic Act Medical device Investigational Device Exemption Medicine Food and Drug Administration Health
16	SOP 4 Human Research Protection Program (HRPP) Documentation and Records Add to Reading List Source URL: ohsr.od.nih.gov Language: English - Date: 2014-03-10 08:08:26 Medicine Science Design of experiments Pharmacology Drug safety Institutional review board Investigational Device Exemption National Institutes of Health Public Responsibility in Medicine and Research Clinical research Research Pharmaceutical industry
17	SOP 11A Closure of an IRB-approved Protocol Add to Reading List Source URL: ohsr.od.nih.gov Language: English - Date: 2014-03-10 08:08:02 Ethics Institutional review board National Institutes of Health Office for Human Research Protections Investigational New Drug Investigational Device Exemption Human subject research NIH Intramural Research Program Clinical research Research Medicine
18	Emory IRB Guidance for Investigators Guidance for the IRB Submission of a Compassionate or Emergency use of an Unapproved Medical Device (including those not under an IDEi) The guidance below is for use of an unapproved Add to Reading List Source URL: www.irb.emory.edu Language: English - Date: 2015-02-04 16:48:37 Pharmaceutical sciences Clinical research Pharmaceutical industry Investigational Device Exemption Food and Drug Administration Expanded access Medical device Investigational New Drug Medicine Pharmacology Research
19	This document is scheduled to be published in the Federal Register onand available online at http://federalregister.gov/a, and on FDsys.govP DEPARTMENT OF HEALTH AND HUMAN SERVICES Add to Reading List Source URL: s3.amazonaws.com Language: English - Date: 2015-05-15 08:45:26 Technology Medical device Investigational Device Exemption Title 21 of the Code of Federal Regulations Premarket approval Center for Devices and Radiological Health Humanitarian Device Exemption Clinical trial ClinicalTrials.gov Food and Drug Administration Medicine Health
20	SOP 15 Research Regulated by the Food and Drug Administration (FDA): General Procedures for Both IND and IDE Applications Add to Reading List Source URL: ohsr.od.nih.gov Language: English - Date: 2014-03-10 08:07:50 Medicine Health Pharmacology Drug safety Food and Drug Administration Institutional review board Investigational Device Exemption Investigational New Drug Clinical trial Clinical research Research Pharmaceutical industry

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