The U.S. Food and Drug Administration (FDA) has officially released its highly anticipated guidance on Pre-Determined Change Control Plans (PCCPs)for medical devices. This new framework is set to streamline regulatory processes and enhance flexibility for device manufacturers, offering a structured approach to managing modifications to approved devices.
PCCPs represent a significant shift in how manufacturers can handle changes to their medical devices. Traditionally, any modification to a device post-approval required a new submission to the FDA, potentially delaying updates and innovations. The PCCP guidance introduces a more proactive approach, allowing manufacturers to outline and obtain FDA agreement on their planned changes before implementation, allowing for modifications of the device over time.
The guidance emphasizes the need for a robust assessment of how proposed changes will impact the device. Manufacturers must demonstrate that their change control plans include procedures for evaluating and mitigating risks associated with modifications. Manufacturers are required to maintain detailed records of changes made under the pre-determined plan. This documentation must be readily accessible for FDA review and must include an assessment of how the change aligns with the pre-approved plan.
In addition to the conditions under which changes to a PMA, de novo or 510(k) submission would be appropriate to put through the PCCP, the guidance offers assistance to manufacturers in the form of decision trees and examples of changes that may be included in a PCCP, particularly when it concerns the safety and efficacy of a device. Conversely, it is noted that the guidance does not include change plans not requiring a new premarket submission. Instead, manufacturers should use their QMS process for maintaining device master records to document changes.
Effective communication with the FDA remains a crucial component. Manufacturers must inform the FDA of any changes made under the pre-determined plan and ensure that these modifications do not compromise the device’s safety or performance.
The FDA has invited public comments on the PCCP guidance to gather feedback from stakeholders. This input will help refine the guidance and ensure that it meets the needs of the medical device industry.
Manufacturers, industry associations, and other interested parties are encouraged to review the guidance and submit their comments on www.regulations.gov under docket no. FDA-2024-D-2338 until November 20, 2024.
For more information and to participate in the feedback process, stakeholders can visit the FDA’s official website and review the detailed guidance document.
Read the guidance here.
