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Index of CDRH Web Documents

KEY: Links are numbered according to what type of file they point to. 1=Text, 2=PDF, 3=PowerPoint, 4=Word, 5=XML, 6=See Also. Topics starting with : 0-9  A  B  C  D  E  F  G  H  I  J  K  L  M  N  O  P  Q  R  S  T  U  V  W  X  Y  Z 
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Some additional items of interest can be found on the Consumer Information page.
 
Quality Control Material
* Points to Consider Guidance Document on Assayed and Unassayed Quality Control Material; Draft [Text] [PDF]
* Preproduction Quality Assurance Planning: Recommendations for Medical Device Manufacturers (FDA 90-4236) [Text]
 
Quality Systems
* FDA Launches Initiative to Improve the Development and Availability of Innovative Medical Products [Text]
* GMP Information / Quality Systems Information [Text]
* Guide to Inspections of Quality Systems (QSIT) [Text] [PDF]
* Guideline on General Principles of Process Validation   [PDF]
* Improving Innovation in Medical Technology: Beyond 2002 [Text]
* Improving Innovation in Medical Technology: Beyond 2002 - Executive Summary [Text]
* Medical Device Manufacturer's Survey Evaluation of FDA Quality System / Good Manufacturing Practice Inspections [Text]
* Medical Device Quality Systems Manual: A Small Entity Compliance Guide [Text]
* Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation [Text]
* Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff   [PDF]
* Reengineering: Good Manufacturing Practices (GMP) Inspection Process [Text]
* Schedule for GMP/QS Workshops with CDRH Participation [Text]
* Y2K Issue for Production Processes and Quality System Software [Text] [PDF]
 

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