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Book 2:  Selected Regulations and Guidance for Medical Device Studies

Book 2: Selected Regulations and Guidance for Medical Device Studies

$ 15.95

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This spiral-bound, 5" x 7.5" book is a compilation of the FDA regulations and guidance documents that govern medical device research.  It includes such topics as:

• Good Clinical Practice/ Protection of Human Subjects
• Premarket Notification (510(k)) Submissions
• Electronic Records and Signatures
• Monitoring and Reporting Adverse Events

Who Uses this Book and How?
• Medical device research staff, as job aids
• Training departments, as training handouts
• Human Resources, as part of new-employee orientation
• Legal/Regulatory/QA staff, for company-wide distribution

What's the Price?
• 1-249 copies:  $15.95             • 250-499 copies:  $14.95
• 500-749 copies: $13.95          • 750+ copies:  $12.95

Custom Cover Prices*?
• 1-24 copies:  unavailable             • 25-100 copies:  $2.00/book
• 100-249 copies: $1.00/book        • 250+ copies:  No charge

* Based on quantities of a single book title

•  CFR Title 21:  Food and Drugs (Revised as of April 1, 2015)

Parts 
11   Electronic Records/Electronic Signatures (Revised 2015)
50   Protection of Human Subjects
54   Financial Disclosure
56   Institutional Review Boards
801 Labeling
803 Medical Device Reporting (Revised 2015)
806 Reports of Corrections and Removals
807 Establishment Registration and Device Listing
812 Investigational Device Exemptions
814 Premarket Approval of Medical Devices
820 Quality System Regulation
822 Postmarket Surveillance
830 Unique Device Identification (Revised 2015)

•  FDA Guidance Documents

•  NEW for 2015: DRAFT Guidance on Medical Device Reporting for Manufacturers
•  Medical Device Reporting for Manufacturers (1997)
•  ICH Guideline on Good Clinical Practice (Step 5, US)

* Need to add or remove a section?
  Give us a call:  866-427-4843

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