Predetermined Change Control Plans for Medical Device Modifications (DRAFT)
This guidance provides FDA's policy and recommendations for Predetermined Change Control Plans (PCCPs) for medical devices. A PCCP allows manufacturers to specify and seek premarket authorization for intended modifications to a device without needing additional marketing submissions before implementing such modifications. The guidance applies to devices requiring premarket approval (PMA), premarket notification (510(k)), or De Novo classification, including device-led combination products.
This is a draft guidance. Not for implementation.
Recommended Actions
- Determine if modifications are appropriate for PCCP inclusion based on risk assessment and guidance criteria
- Develop comprehensive PCCP documentation including:
- Description of Modifications
- Modification Protocol
- Impact Assessment
- Traceability matrix
- Implement quality system controls for PCCP management
- Establish procedures for:
- Version control
- Documentation
- User communication
- Post-market surveillance
- Consider early FDA engagement through Q-Submission Program
- Ensure labeling properly reflects PCCP and modifications
- Maintain records of all modifications implemented under PCCP
- Monitor device performance and safety as modifications are implemented
- Submit appropriate regulatory submissions when modifications fall outside PCCP scope
- Update PCCP as needed through new marketing submissions
Key Considerations
Non-clinical testing
- Performance evaluation methods should include verification and validation plans to ensure modified device meets specifications
- Testing methods and acceptance criteria should be pre-defined in the Modification Protocol
- More comprehensive testing can potentially support a broader set of proposed modifications
Software
- Software changes must maintain device within intended use
- Minor software changes to improve performance may be appropriate for PCCP
- Major software architecture changes are generally not appropriate for PCCP
Labelling
- Must comply with applicable statutes and regulations
- Should include statement that device has authorized PCCP
- Should describe implemented modifications and how users will be informed
- Must include adequate directions for use
- Should reflect current version information
Safety
- Modifications must maintain device safety and effectiveness
- Impact Assessment required to evaluate benefits and risks
- Post-market surveillance plans required
- Changes to address recalls/safety issues not appropriate for PCCP
Other considerations
- PCCP must be specific and limited in scope
- Changes must maintain device within intended use
- Manufacturing changes must comply with Quality System Regulation
- Version control and traceability required
- Early FDA engagement recommended for PCCP development
Relevant Guidances
- Deciding When to Submit a New 510k for Changes to an Existing Medical Device
- Deciding When to Submit a New 510k for Software Changes to Medical Devices
- Content of Premarket Submissions for Device Software Functions
- Quality System Information Requirements for Premarket Submissions
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
Related references and norms
- ISO 14971: Medical devices – Application of risk management to medical devices
- ANSI/AAMI ES60601-1: Medical electrical equipment safety
- IEC 60601-1-2: EMC requirements
- ISO 13485: Medical devices – Quality management systems
Original guidance
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