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Center for Devices and Radiological Health
Results: 3105

#	Item
701	FDA Small Business Contacts Add to Reading List Source URL: www.fda.gov. Language: English Clinical research Center for Devices and Radiological Health Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Center for Food Safety and Applied Nutrition Office of Regulatory Affairs FDA Warning Letter Food and Drug Administration Medicine Health
702	Guidance for Industry and FDA Staff: Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications Hello. My name is Elias Mallis, the Director of the Divisi Add to Reading List Source URL: www.fda.gov. Language: English Technology Medical device Premarket approval Center for Devices and Radiological Health Risk assessment Risk Clinical trial Federal Food Drug and Cosmetic Act Food and Drug Administration Medicine Health
703	FDA CASE STUDY JUne 2014 An infusion pump company considers risk assessment and mitigation Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Medical equipment Actuarial science Medical device Infusion pump Center for Devices and Radiological Health Premarket approval Validation Safety assurance Medicine Risk Ethics
704	ASSOCIATION OF DTSPOSABLEDEVICE MANUFACTURERS Providing industry views on single patient me medical devices December 8,200O BY HAND DELIVERY Add to Reading List Source URL: www.fda.gov Language: English - Date: 2001-01-09 05:49:45 Technology Medical device Federal Food Drug and Cosmetic Act Center for Devices and Radiological Health Investigational Device Exemption Medicine Food and Drug Administration Health
705	COOK’ Cook Group Incorporated 405 N. Rogers Street, [removed]PO Box[removed]l 608 U.S.A. Add to Reading List Source URL: www.fda.gov Language: English - Date: 2004-04-27 17:56:00 Technology Medical device Center for Devices and Radiological Health Federal Food Drug and Cosmetic Act Design controls Biologic Premarket approval Investigational Device Exemption Validation Food and Drug Administration Medicine Health
706	PDF Document Add to Reading List Source URL: www.fda.gov Language: English - Date: 2001-11-19 05:18:12 Technology Epilator Tweezers Hair removal Federal Food Drug and Cosmetic Act Center for Devices and Radiological Health Food and Drug Administration Electric tweezers Depilation Medicine Health
707	DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville MD 20857 Add to Reading List Source URL: www.fda.gov Language: English - Date: 2007-11-13 16:07:13 Medical equipment Interventional cardiology Drug-eluting stent Implants Federal Food Drug and Cosmetic Act Premarket approval Center for Devices and Radiological Health Medical device Coronary stent Medicine Food and Drug Administration Health
708	DEPARTMENT OF HEALTH & HUMAN SERVICES 1 Add to Reading List Source URL: www.fda.gov Language: English - Date: 2005-01-05 16:24:55 Mammography Quality Standards Act Center for Devices and Radiological Health Mammography Medicine Health Food and Drug Administration
709	Documen;t issued on: [Level 2, w NOA, use NOAdate] This doeument supqrsedt3s “A Pilot Progrqm to:,1Evaluiaee:a,ProposedGlobally Harmonized AfternatiVe for Premqrket ~r~~~d~~~s~ ~~~an~~ for Industry and FDA Staff,” da Add to Reading List Source URL: www.fda.gov Language: English - Date: 2005-11-08 09:17:08 Medical equipment Health Premarket approval Global Harmonization Task Force Medical device Center for Devices and Radiological Health Medicine Food and Drug Administration Technology
710	DOC Document Add to Reading List Source URL: www.fda.gov Language: English - Date: 2004-12-27 14:03:56 Pharmaceuticals policy Pharmaceutical sciences Pharmaceutical industry Food safety United States Public Health Service Good manufacturing practice Medical device Quality management system Center for Devices and Radiological Health Food and Drug Administration Medicine Health

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