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Compliance Requirements for Ophthalmic Drug-Device Combination Products Following Genus Decision

This guidance addresses compliance requirements for ophthalmic drugs packaged with eye cups, eye droppers, or other dispensers, which are now regulated as drug-led combination products following the Genus Medical Technologies LLC court decision. It applies to products with pending applications, approved products, and OTC monograph drugs.

  1. Update Form FDA 356h to identify the product as a combination product and list all manufacturing facilities
  2. Develop and implement policies and procedures for:
    • Quality System requirements compliance
    • Postmarketing safety reporting
    • Design controls
  3. Create or update design history file by:
    • Leveraging existing data and specifications
    • Documenting design verification and validation
    • Establishing design review procedures for future changes
  4. Assess compliance gaps with Part 4 requirements and develop action plan
  5. Prepare summary information describing compliance with device QS regulation if requested by FDA
  6. Monitor FDA communications regarding application of Part 820 requirements to lower-risk device constituent parts
  7. Implement postmarketing safety reporting system for combination products within 12 months of guidance publication

Key Considerations

Safety

  • Compliance with postmarketing safety reporting requirements for combination products (21 CFR Part 4, subpart B)

Other considerations

  • 21 CFR Part 820: Quality System Regulation
  • 21 CFR Part 4: Current Good Manufacturing Practice Requirements for Combination Products
  • 21 CFR Parts 210 and 211: Current Good Manufacturing Practice for Drugs

Original guidance

  • Compliance Requirements for Ophthalmic Drug-Device Combination Products Following Genus Decision
  • HTML / PDF
  • Issue date: 2022-03-22
  • Last changed date: 2022-03-22
  • Status: FINAL
  • Official FDA topics: Medical Devices, Combination Products, Drugs, Biologics
  • ReguVirta summary file ID: c5058f2e80371e77ea2a316dad3d1acf
This post is licensed under CC BY 4.0 by the author.