Guide to FDA Regulation of In Vitro Diagnostic (IVD) Devices

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Guide to FDA Regulation of In Vitro Diagnostic (IVD) Devices

Devicemakers, IVD marketers and clinical labs struggle often with FDA regulation — and it’s no wonder. The rules governing IVDs are scattered throughout the CFRs, and exceptions, special cases and pitfalls abound. Some hapless firms have even followed the wrong set of rules — and endured 483s or warning letters as a result.

Guide to FDA Regulation of In Vitro Diagnostic (IVD) Devices brings together all the disparate parts of IVD regulations and guidances and provides an expert interpretation of requirements, including:

  • Clear technical and practical definitions of different types of IVDs, including multivariate index assays, analyte-specific reagents, research use only IVDs, investigational IVDs and laboratory-developed tests
  • How to apply UDI rules to IVDs, especially in convenience kits
  • How to develop and label companion devices
  • The FDA’s enforcement policy for premarket notification
  • Rules on calibrating IVD instruments

This first-of-its-kind guide has all the regulatory resources you need:

  • 21 CFR parts 801, 803, 806, 809, 812 and 820;
  • 21 CFR Part 211.166, the only drug regulation that impacts IVDs;
  • 42 CFR Part 493 on laboratory-developed tests; and
  • FDA draft and final guidances, including:
    • Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators
    • Assayed and Unassayed Quality Control Material
    • Molecular Diagnostic Instruments with Combined Functions
    • In Vitro Diagnostic Multivariate Index Assays
    • In Vitro Companion Diagnostic Devices
    • Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product
    • Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only

Guidance documents are few and far between, and new ones are not expected any time soon. Guide to FDA Regulation of In Vitro Diagnostic (IVD) Devices is your opportunity to clear up regulatory confusion. Order your copy today.

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Who Will Benefit

  • Quality Managers of IVD manufacturers
  • Lab Directors who use ASRs
  • Lab Directors who perform High Complexity Testing under the CLIA regulations
  • Regulatory Managers of IVD manufacturers
  • Sales Managers of IVD manufacturers
  • Compliance Managers of IVD manufacturers
  • Compliance Managers of High Complexity labs

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