The U.S. Food and Drug Administration (FDA) has released a guidance document titled "Predetermined Change Control Plans for Medical Devices" providing a framework for the development and implementation of change control plans in medical devices. FDA is issuing this draft guidance to propose a policy for Predetermined Change Control Plans (PCCPs) and recommendations on the information to include in a PCCP in a marketing submission for a device.
A PCCP is the documentation describing what modifications will be made to a device and how the modifications will be assessed. According to this draft guidance, a device PCCP must explain the planned device modifications, the methodology for developing, validating, and implementing those modifications, and the impact of the modifications.
As part of a device's marketing submission, FDA reviews the PCCP to ensure the device remains safe and effective without having to submit additional marketing submissions for each modification described in the PCCP. In this draft guidance, recommendations are made for devices, including device-led combination products, reviewed under 510(k), De Novo, or PMA.
This guidance elaborates on the FDA’s policy regarding PCCPs, including detailed information on the components, establishment, and implementation of PCCPs.
A. Components of a PCCP The components include a detailed description of anticipated modifications, a modification protocol, and an impact assessment, all of which must be included in the PCCP.
B. Establishing a PCCP Manufacturers must establish a PCCP during the premarket submission process, outlining the types of changes they anticipate making to the device and the methods for implementing these changes.
C. Identifying a PCCP in a Marketing Submission The PCCP must be clearly identified and included in the initial marketing submission, whether it is a PMA, 510(k), or De Novo request.
D. Utilizing an Authorized PCCP to Implement Device Modifications Once a PCCP is authorized by the FDA, manufacturers can implement the specified changes without additional submissions, provided the changes adhere strictly to the approved plan.
E. Modifying a Previously Authorized PCCP If a manufacturer needs to modify an existing PCCP, they must submit the proposed changes to the FDA for review and approval before implementation.
F. Version Control and Maintenance of a PCCP for a Device Manufacturers are required to maintain version control for their PCCPs, ensuring that all changes are documented and traceable.
The types of modifications that may be included in a PCCP, are categorized by the type of FDA submission (510(k), De Novo, or PMA).
A. Determining Whether a Modification may be Appropriate for Inclusion in a PCCP in a 510(k) or De Novo Submission The guidance outlines criteria for determining whether a proposed change can be included in a PCCP as part of a 510(k) or De Novo submission.
B. Determining Whether a Modification may be Appropriate for Inclusion in a PCCP in a PMA Application or Supplement Similar criteria are provided for changes included in a PCCP within a PMA application or supplement.
By allowing manufacturers to pre-plan and obtain approval for changes, this guidance facilitates innovation and adaptability while maintaining rigorous safety standards. For more detailed information, please refer to the official US FDA document.
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