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FDA Code of Federal Regulations Mini-Handbooks!
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CFR Rule Changes by GXPNews

Medical Device Industry Handbooks
Medical Device Combination - Standard

Good Clinical Practices (GCP) Regulations for Medical Devices

21 CFR and ICH Parts:

  • 11 - Electronic Records; Electronic Signatures
  • 50 - Protection of Human Subjects
  • 54 - Financial Disclosure by Clinical Investigators
  • 56 - Institutional Review Boards
  • 807 - Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
  • 812 - Investigational Device Exemptions
  • 814 - Premarket Approval of Medical Devices
  • 820 - Quality Systems Regulations
  • The 510k & Premarket Approval (PMA) Guidance Document

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Part 50 - Protection of Human Subjects
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Part 54 - Financial Disclosure by Clinical Investigators
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Part 56 - Institutional Review Boards
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Part 801 - Labeling - Medical Device
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Part 803 - Medical Device Reporting
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Part 806 - Medical Devices; Reports of Corrections and Removal
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Part 807 - Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
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Part 809 - In-Vitro Diagnostic Products
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Part 810 - Medical Device Recall Authority
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Part 812 - Investigational Device Exemptions
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Part 814 - Premarket Approval of Medical Device
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Part 820 - Quality System Regulations
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Parts 11 and 820
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Parts 11, 210/211 & 820
Parts 11, 210/211 & 820 - The GMP Predicate Rules
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PMA and 510k Guidelines
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Basic EU GMPs Chapter 1 - 9
$6.90
5 Book Minimum! Basic EU GMPs Chapter 1 through 9 with Glossary
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