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Investigational Device Exemption
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1	Food and Drug Administration, HHS § 50.3 PART 50—PROTECTION OF HUMAN SUBJECTS Add to Reading List Source URL: publicfiles.jaeb.org Language: English - Date: 2014-01-30 11:37:23 Medical research Research Clinical research Medical ethics Pharmaceutical industry Food and Drug Administration Investigational device exemption Clinical trial Institutional review board Informed consent Clinical investigator Human subject research
2	Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff Add to Reading List Source URL: www.fda.gov Language: English Health Medicine Medical technology Food and Drug Administration Medical device Medical equipment Investigational device exemption Electronic health record Interoperability Federal Food Drug and Cosmetic Act Interface Biomedical engineering
3	Special circumstances regarding expanded access at Stanford In most circumstances, medical research using investigational drugs, biologics and devices Add to Reading List Source URL: humansubjects.stanford.edu Language: English - Date: 2016-04-12 01:21:50 Health Medical research Clinical pharmacology Pharmaceutical industry Food and Drug Administration Design of experiments Clinical research Expanded access Clinical trial Institutional review board Treatment IND Investigational device exemption
4	FAQ’s for Qualifying Clinical Trials What is a qualifying clinical trial? Medicare covers the routine costs of “qualifying clinical trials” as defined below, as well as reasonable and necessary items and services u Add to Reading List Source URL: ictr.research.bcm.edu Language: English - Date: 2014-12-12 11:31:57 Medical research Health Pharmaceutical industry Clinical research Healthcare reform in the United States Medicare Presidency of Lyndon B. Johnson National coverage determination Clinical trial Investigational device exemption
5	Microsoft Word - SOP - Informed Consent - Types and Elements.doc Add to Reading List Source URL: research.missouri.edu Language: English - Date: 2015-07-01 12:44:32 Medical research Medical ethics Research Applied ethics Clinical research ethics Clinical research Pharmaceutical industry Human subject research Institutional review board Informed consent Clinical trial Investigational device exemption
6	Microsoft Word - MAGI_Model_CTA v1.07 Abbreviated.doc Add to Reading List Source URL: magiworld.org Language: English - Date: 2015-12-14 16:21:29 Clinical research Pharmaceutical industry Clinical trials Design of experiments Food and Drug Administration Contract research organization Institutional review board Case report form Investigational device exemption Site management organization Clinical research coordinator Monitoring in clinical trials
7	Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions - Draft Guidance for Industry and Food and Drug Administration Staff Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Healthcare quality Actuarial science Medical terminology Pharmaceuticals policy Risk management Medical device Federal Food Drug and Cosmetic Act Center for Devices and Radiological Health Patient safety Investigational device exemption Adverse effect
8	§ CFR Ch. I (4–1–12 Edition) (3) Requesting that the applicant conduct additional independent studies Add to Reading List Source URL: publicfiles.jaeb.org Language: English - Date: 2014-01-30 11:37:27 Clinical research Pharmaceutical industry Food and Drug Administration Design of experiments Institutional review board Clinical trial Public Responsibility in Medicine and Research Investigational device exemption Office for Human Research Protections Clinical investigator Human subject research Covered clinical study
9	Fiscal Year 2016 Investigational New Drug (IND) or Investigational Device Exemption (IDE) Documentation Form CDMRP Log Number:_________________ Principal Investigator’s (PI’s) Name (please print):____________________ Add to Reading List Source URL: cdmrp.org Language: English
10	Investigational Device Exemption (IDE) Submission Checklist Please checkCover Letter Statement that submission is an original IDE application Sponsor Information (Name, Address) Add to Reading List Source URL: floridaresearchinstruments.com Language: English - Date: 2014-04-24 03:21:09

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