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Design controls
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#	Item
201	Attachment E CDRH Final Guidance Cover Sheet Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Health Quality Medical equipment Design history file Validation Medical device Design controls Center for Devices and Radiological Health Medicine Technology Food and Drug Administration
202	Guidance for Industry and FDA Staff Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Pharmaceutical industry Clinical research Food law Pharmacology Federal Food Drug and Cosmetic Act Center for Devices and Radiological Health Validation Design controls Food and Drug Administration Medicine Health
203	Dental Composite Resin Devices - Premarket Notifications [510(k)] Submissions - Guidance for Industru and FDA Staff Add to Reading List Source URL: www.fda.gov Language: English Technology Federal Food Drug and Cosmetic Act Center for Devices and Radiological Health Quality management system Design controls Title 21 of the Code of Federal Regulations Premarket approval Medical device Food and Drug Administration Medicine Health
204	Class II Special Controls Guidance Document: Dental Base Metal Allows Add to Reading List Source URL: www.fda.gov Language: English Health Food law Medical equipment Medical technology Pharmaceuticals policy Medical device Federal Food Drug and Cosmetic Act Center for Devices and Radiological Health Design controls Medicine Technology Food and Drug Administration
205	Attachment E CDRH Final Guidance Cover Sheet Add to Reading List Source URL: www.fda.gov Language: English Technology Clinical research Pharmaceutical industry Food law Pharmacology Medical device Center for Devices and Radiological Health Federal Food Drug and Cosmetic Act Design controls Medicine Food and Drug Administration Health
206	Attachment E CDRH Final Guidance Cover Sheet Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Health Quality Medical equipment Design history file Validation Medical device Design controls Center for Devices and Radiological Health Medicine Technology Food and Drug Administration
207	Guidance for Industry and FDA Staff Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed SingleUse Medical Devices Add to Reading List Source URL: www.fda.gov Language: English Health Pharmaceutical industry Medical equipment Clinical research Validity Validation Medical device Design controls Federal Food Drug and Cosmetic Act Medicine Food and Drug Administration Technology
208	Guidance for Industry Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices Add to Reading List Source URL: www.fda.gov Language: English Health Magnetic resonance imaging Medical device Center for Devices and Radiological Health Specific absorption rate Resonance Design controls Medicine Food and Drug Administration Technology
209	Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment Add to Reading List Source URL: www.fda.gov Language: English Technology Center for Devices and Radiological Health Federal Food Drug and Cosmetic Act Premarket approval Design controls Quality management system Design history file Title 21 of the Code of Federal Regulations Medical ultrasonography Medicine Food and Drug Administration Health
210	The Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012, amended, among other sections, section 513(f) of the Federal Food, Drug, and Cosmetic Act. The guidance entitled New S Add to Reading List Source URL: www.fda.gov Language: English Technology Premarket approval Federal Food Drug and Cosmetic Act Center for Devices and Radiological Health Investigational Device Exemption Design controls Title 21 of the Code of Federal Regulations Medical device New Drug Application Food and Drug Administration Medicine Health

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