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Center for Devices and Radiological Health
Results: 3105

#	Item
561	CENTER FOR DEVICES AND RADIOLOGICAL HEALTH Guidance Development (Includes Special Controls Guidance Documents) CONTENTS PURPOSE Add to Reading List Source URL: www.fda.gov Language: English Clinical research Documents Guidance document Publications Center for Devices and Radiological Health Food and Drug Administration Pharmaceutical sciences Medicine
562	Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Medical technology Pharmaceuticals policy Pharmaceutical industry Medical device Medical equipment Center for Devices and Radiological Health Validation Federal Food Drug and Cosmetic Act Medicine Health Technology
563	Regulatory Background on Reclassification Add to Reading List Source URL: www.fda.gov Language: English Technology Premarket approval Medical device Federal Food Drug and Cosmetic Act Humanitarian Device Exemption Clinical trial Investigational Device Exemption Center for Devices and Radiological Health Food and Drug Administration Medicine Health
564	Guidance for Industry General/Specific Intended Use Document Issued: November 4, 1998 Add to Reading List Source URL: www.fda.gov Language: English Technology Premarket approval Medical device Federal Food Drug and Cosmetic Act Center for Devices and Radiological Health Clinical trial Indication Title 21 of the Code of Federal Regulations Investigational Device Exemption Medicine Food and Drug Administration Health
565	Contains Nonbinding Recommendations Refuse to Accept Policy for 510(k)s Guidance for Industry and Food and Drug Administration Staff Add to Reading List Source URL: www.fda.gov Language: English Technology Premarket approval Medical device Center for Devices and Radiological Health Federal Food Drug and Cosmetic Act Food and Drug Administration Medicine Health
566	Evaluation of Sex-Specific Data in Medical Device Clinical Studies Add to Reading List Source URL: www.fda.gov. Language: English Clinical research Pharmaceutical industry Pharmacology Medical statistics Medical device Center for Devices and Radiological Health Clinical trial Premarket approval Ventricular assist device Medicine Health Food and Drug Administration
567	Appendix 1: Medical Device User Fee Cover Sheet Add to Reading List Source URL: www.fda.gov Language: English Technology Premarket approval Prescription Drug User Fee Act Center for Devices and Radiological Health Medical device Fee Biologic License Application Food and Drug Administration Medicine Health
568	Contains Nonbinding Recommendations Draft - Not for Implementation Accreditation and Reaccreditation Process for Firms under the Third Party Review Program: Part I Add to Reading List Source URL: www.fda.gov Language: English Technology Federal Food Drug and Cosmetic Act Medical device Center for Devices and Radiological Health TPR Storytelling Food and Drug Administration Medicine Health
569	FAQs on the Status of Reprocessed Single Use Devices (SUDs) that receive a Not Substantially Equilant (NSE) Letter) Add to Reading List Source URL: www.fda.gov Language: English Technology Center for Devices and Radiological Health Premarket approval Federal Food Drug and Cosmetic Act Medical device Validation Food and Drug Administration Medicine Health
570	Guidance for Clinical Laboratory Improvement Amendments of[removed]CLIA) Criteria for Waiver; Draft Guidance for Industry and FD Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Clinical research Pharmacology Medical technology Medical device Clinical Laboratory Improvement Amendments Validation Center for Devices and Radiological Health Clinical trial Medicine Health Food and Drug Administration

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