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 guidehas 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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PDF Edition — $397
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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