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This is a draft guidance. Not for implementation.
What You Need to Know? 👇
What is a Predetermined Change Control Plan (PCCP) for medical devices?
A PCCP is documentation describing planned device modifications and how they will be assessed. It allows manufacturers to implement specific changes without requiring separate FDA submissions for each modification, provided changes follow the authorized protocol.
Which submission types can establish a PCCP?
PCCPs can be established through PMA applications (original, modular, supplements), 510(k) submissions (traditional, abbreviated), and De Novo requests. The PCCP becomes part of the device’s marketing authorization once approved or cleared.
What modifications are generally appropriate for inclusion in a PCCP?
Appropriate modifications include certain design changes, software updates for compatibility, material/component changes using well-established methods, sterilization changes, and specific labeling updates that maintain the device’s intended use and safety profile.
How does a PCCP affect substantial equivalence determinations for 510(k) devices?
When using a predicate device with a PCCP, the subject device must be compared to the version cleared before any PCCP modifications were implemented. Only the original authorized version can serve as a predicate.
What are the three main components required in a PCCP?
A PCCP must include: (1) Description of Modifications - specific planned changes; (2) Modification Protocol - verification/validation methods and acceptance criteria; and (3) Impact Assessment - benefits, risks, and mitigation strategies for the modifications.
What happens if a manufacturer deviates from their authorized PCCP?
Deviations from an authorized PCCP could significantly affect device safety or effectiveness, potentially making the device adulterated and misbranded. Such deviations typically require a new marketing submission before implementation.
What You Need to Do 👇
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
- Q-Submission Program: Strategic Framework for FDA Interactions in Medical Device Development
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