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.
Recommended Actions
- Update Form FDA 356h to identify the product as a combination product and list all manufacturing facilities
- Develop and implement policies and procedures for:
- Quality System requirements compliance
- Postmarketing safety reporting
- Design controls
- Create or update design history file by:
- Leveraging existing data and specifications
- Documenting design verification and validation
- Establishing design review procedures for future changes
- Assess compliance gaps with Part 4 requirements and develop action plan
- Prepare summary information describing compliance with device QS regulation if requested by FDA
- Monitor FDA communications regarding application of Part 820 requirements to lower-risk device constituent parts
- 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
- Compliance with Quality System Regulation (21 CFR Part 820) requirements
- Development and implementation of policies and procedures for combination product compliance
- Submission of updated Form FDA 356h identifying the product as a combination product
- Documentation of design control activities and design history file
- Quality-by-Design principles should be broadened to account for all constituent parts
- Existing data can be leveraged for design history file development
- Design and development plan must be in place for future design activities
Relevant Guidances
- Current Good Manufacturing Practice Requirements for Combination Products
- Compliance Policy for Combination Product Postmarketing Safety Reporting Requirements
- Postmarketing Safety Reporting Requirements for Combination Products
- Quality System Information Requirements for Premarket Submissions
Related references and norms
- 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
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