FDA New Draft Guidance to expand the use of Pre-determined Change control Plans (PCCPs) from just AI/ML to now all medical devices

  • August 21, 2024
  • News

By Elle Winn, Mittal Consulting

On August 22, 2024, the FDA released a new draft guidance discussing Predetermined Change Control Plans for Medical Devices. Predetermined change control plans (PCCPs) are FDA-authorized plans to implement changes to a medical device at a later point that are included in and approved in a marketing submission to the FDA. PCCPs support iterative device improvement using prospective FDA review and authorization of proposed changes. Before the release of this guidance, PCCP plans were limited to Artificial Intelligence/Machine Learning (AI/ML)-equipped software devices; however, with the release of this guidance, any medical device or device-led combination product is now eligible to submit a PCCP in their marketing submission. This expansion of the PCCP program is an important change and has the capacity to impact regulatory strategy for many medical device manufacturers.

The guidance uses a few guiding principles when discussing PCCP plans, including:

  • There must be reasonable assurance of safety and effectiveness (and substantial equivalence, if applicable) of the devices with predetermined change control plans.
  • PCCPs are voluntary and intended to be the least burdensome option for both manufacturers and the FDA to support device modifications.
  • PCCPs are a part of a marketing authorization.
  • PCCPs are specific.
  • PCCPs harmonize with existing FDA device modification guidances.

There are limits to what changes can be included in a PCCP. Changes the FDA expects to be appropriate in a PCCP are those that maintain the device within its intended use and, for those undergoing 510(k) clearance, maintain the device’s substantial equivalence to the predicate. Generally, modifications that are acceptable in a PCCP are minor, do not introduce new hazards, or change the intended use of the device. PCCPs are intended to include changes that may influence the device’s safety and/or effectiveness and would otherwise require a new pre-market submission. Having a method for the FDA to prospectively authorize changes enables manufacturers to implement changes according to a pre-specified protocol without submitting a new marketing application. The FDA notes that it is expected that changes made in accordance with an authorized PCCP must adhere to the company’s quality system. Changes that were not included in the authorized PCCP or changes that cannot be made in accordance with the PCCP are expected to require an additional marketing submission. Additionally, modifications to the PCCP itself will require a new marketing submission.

Establishing a PCCP is done in a pre-market submission for the device or device-led combination product for which the PCCP applies. A PCCP can be established through the PMA pathway, 510(k) pathway, or De Novo pathway. FDA expects that review of a pre-market submission with a PCCP will be an interactive one, as the PCCP may require multiple versions before the FDA is able to determine whether the device is safe and effective under it. Additionally, the FDA strongly recommends early engagement between manufacturers and the Agency while developing a PCCP to ensure the strongest chance of a PCCPs successful authorization. This engagement could be through the FDA’s free and voluntary Q-Submission program.

The primary components of a PCCP plan include description of modifications, which specifically discusses each change to the device that will be made under the PCCP; a modification protocol section, which outlines how the changes will be implemented and explains the verification and validation procedures that will be performed to ensure the device’s safety and effectiveness; and an impact assessment which discusses the risks and benefits of implementing such changes. There must be traceability between each modification discussed in the description of modifications and steps in the modification protocol. 

Like other devices, those approved with a PCCP plan still must adhere to relevant labeling regulations. In addition, FDA recommends that the labeling for a device with the PCCP notes that it has an authorized PCCP plan for full transparency to users. FDA also recommends that the labeling is updated as authorized changes occur to inform users about any changes in use that come with the changes. Similarly, FDA notes that a description of the PCCP should be included in publicly available locations including a PMA summary of safety and effectiveness document (SSED) and approval order, 510(k) summary, or De Novo decision summary.

The FDA will be accepting comments and suggestions regarding the draft guidance for the next 90 days (until Nov. 20, 2024). After finalizing this draft guidance, FDA will make updates to several other guidance documents that discuss when changes require a new pre-market submission, including: