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Marketing and Distribution Requirements for Analyte Specific Reagents (ASRs)

This guidance clarifies regulations regarding commercially distributed analyte specific reagents (ASRs) and the role and responsibilities of ASR manufacturers. It addresses frequently asked questions about ASR marketing practices and provides FDA's responses. The guidance focuses on ASRs as building blocks of Laboratory Developed Tests (LDTs) and aims to eliminate confusion regarding particular marketing practices among ASR manufacturers.

  1. Review current ASR marketing practices to ensure compliance with regulations
  2. Ensure proper labeling of ASRs without performance claims or instructions for use
  3. Implement and maintain cGMP system for ASR manufacturing
  4. Establish process for medical device reporting
  5. Register and list ASRs with FDA
  6. Determine proper classification of ASRs (Class I, II, or III)
  7. Obtain necessary premarket clearance/approval for Class II/III ASRs
  8. Review sales channels to ensure ASRs are only sold to authorized entities
  9. Ensure ASRs are not promoted with specific instruments or software
  10. Maintain clear separation between ASRs and other products (GPRs, controls, etc.)

Key Considerations

Software

  • Software cannot be marketed for use with specific ASRs
  • If ASR is marketed with software, it’s no longer considered an ASR

Labelling

  • Must include statement “Analyte Specific Reagent. Analytical and performance characteristics are not established”
  • Must include proper storage and handling instructions
  • Cannot include instructions for developing or performing an assay
  • Can include scientific information on chemical/molecular composition, concentration, sequence, etc.
  • Cannot make clinical or analytical performance claims

Safety

  • Must follow current Good Manufacturing Practices (cGMPs)
  • Must submit medical device reports

Other considerations

  • 21 CFR Part 820: Quality System Regulation
  • 21 CFR 809.10: Labeling for in vitro diagnostic products
  • 21 CFR 864.4020: Analyte Specific Reagents
  • 42 CFR 493: Laboratory Requirements (CLIA)

Original guidance

  • Marketing and Distribution Requirements for Analyte Specific Reagents (ASRs)
  • HTML / PDF
  • Issue date: 2007-09-13
  • Last changed date: 2020-02-28
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket, Good Clinical Practice (GCP)
  • ReguVirta summary file ID: a8b1786843e280f33402d1887779feeb
This post is licensed under CC BY 4.0 by the author.