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Center for Devices and Radiological Health
Results: 3105

#	Item
151	General Wellness: Policy for Low Risk Devices Draft Guidance for Industry and Food and Drug Administration Staff DRAFT GUIDANCE Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Pharmaceutical sciences Medical device Center for Devices and Radiological Health Wellness Regulatory requirement Dietary supplement Quality management system Federal Food Drug and Cosmetic Act Medicine Pharmaceuticals policy Health
152	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
153	DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration[removed]New Hampshire Avenue Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2014-11-25 13:17:39 Technology Premarket approval Medical device Center for Devices and Radiological Health Breast implant Unique Device Identification Federal Food Drug and Cosmetic Act Breast augmentation Adverse event Medicine Food and Drug Administration Health
154	Attachment E CDRH Final Guidance Cover Sheet Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Pharmacology Center for Devices and Radiological Health Medical device Title 21 of the Code of Federal Regulations Laser safety IEC 60601 Medicine Technology Health
155	Premarket Notification [510(k)] Submissions for Chemical Indicators Add to Reading List Source URL: www.fda.gov Language: English Medical equipment Hygiene Pharmaceuticals policy Electron beam Sterilization Medical device Autoclave Center for Devices and Radiological Health Federal Food Drug and Cosmetic Act Medicine Health Food and Drug Administration
156	Monthly Newsletter – Pharma & Healthcare July 2014 Ingenious e-Brain Solutions 1\|Page Add to Reading List Source URL: www.ingeniousebrainsolutions.com Language: English - Date: 2014-09-04 06:02:39 Technology Center for Devices and Radiological Health Medical device Medtronic Federal Food Drug and Cosmetic Act Hospira Recall Class I recall Medicine Food and Drug Administration Health
157	United States Court of Appeals FOR THE DISTRICT OF COLUMBIA CIRCUIT Argued April 8, 2014 Decided September 26, 2014 Add to Reading List Source URL: www.cadc.uscourts.gov Language: English - Date: 2015-01-13 10:55:46 Technology Center for Devices and Radiological Health Federal Food Drug and Cosmetic Act Premarket approval Medical device Clinical research Food and Drug Administration Medicine Health
158	FDA National Center for Toxicological Research Add to Reading List Source URL: www.fda.gov Language: English Safety National Center for Toxicological Research NOAA Center for Tsunami Research Regulatory science Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for Food Safety and Applied Nutrition Regulatory requirement National Institute of Environmental Health Sciences Food and Drug Administration Health Medicine
159	Guidance for Industry and FDA Staff Add to Reading List Source URL: www.fda.gov Language: English Health Safety clothing Medical technology Food and Drug Administration Food law Medical device Medical glove Center for Devices and Radiological Health Federal Food Drug and Cosmetic Act Medicine Gloves Clothing
160	Vocal Fold Medialization Devices - Premarket Notification [510(k)] Submissions - Guidance Add to Reading List Source URL: www.fda.gov Language: English Health Clinical research Pharmaceutical industry Medical equipment Pharmacology Medical device Center for Devices and Radiological Health Federal Food Drug and Cosmetic Act Validation Medicine Food and Drug Administration Technology

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