GUIDANCE DOCUMENT
Predetermined Change Control Plans for Medical Devices Draft Guidance for Industry and FDA Staff August 2024
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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All written comments should be identified with this document's docket number: FDA-2024-D-2338
- Docket Number:
- FDA-2024-D-2338
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Guidance Issuing OfficeCenter for Devices and Radiological HealthCenter for Biologics Evaluation and Research
FDA is issuing this draft guidance to propose a policy for Predetermined Change Control Plans (PCCPs) and recommendations on the information to include in a PCCP in a marketing submission for a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. This draft guidance recommends that a PCCP for a device describe the planned device modifications, the associated methodology to develop, validate, and implement those modifications, and an assessment of the impact of those modifications. FDA reviews the PCCP as part of a marketing submission for a device to ensure the continued safety and effectiveness of the device without necessitating additional marketing submissions for implementing each modification described in the PCCP. The recommendations in this draft guidance apply to devices, including device-led combination products, reviewed through the 510(k), De Novo, and PMA pathways.