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Do you make an AI/ML-enabled software product? If the answer is yes, the FDA’s PCCP is designed for you and may reduce the burden of additional regulatory submissions in the future.
In this post, we cover the following:
- What is the FDA PCCP for AI/ML products?
- What to consider when preparing your PCCP?
- How to define the scope of modifications in your PCCP?
- How to incorporate the PCCP into your documentation?
What is the FDA PCCP for AI/ML products?
In April 2023, FDA issued a draft guidance on Marketing Submission Recommendations for a Predetermined Change Control Plans (PCCP) for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions (ML-DSF). Applicable to medical devices that use ML models trained by ML algorithms, this draft guidance is intended to provide best practices on how to make software/device improvements without affecting device safety or effectiveness, while minimizing the regulatory burden and helping ensure improvements get to market faster.
A PCCP is designed to cover changes that would otherwise require a new marketing submission prior to commercialization. The FDA’s intention is that the PCCP is submitted as part of a marketing submission. From there, it is reviewed as part of the overall marketing submission for the device. And once a PCCP has been reviewed and established through a marketing submission, the PCCP is considered part of the marketing authorization and the device now has an “authorized PCCP”.
Once an authorized PCCP has been established, manufacturers can make modifications to the ML-DSF in alignment with the PCCP, without seeking any additional authorization. In alignment with the PCCP means both in the change itself as well as execution of the change in accordance with the predefined methods and specifications. This new approach allows for the routine updates software needs and helps taking advantage of the nature of AI/ML software in its ability to learn and, ideally, improve. By incorporating a PCCP within a marketing authorization, manufacturers can commercialize upon product improvements faster than waiting for each change to be reviewed and cleared/granted/approved.
We've created a PCCP template will save you time in developing your plan. The template comes in Word format and includes instructions and tips on creating your plan, along with substantial details on content to include based on the FDA’s guidance.
Want to keep learning about the FDA’s PCCP? And, create your own in five steps.
While the FDA draft guidance provides the key elements to include in the PCCP, it's critical to understand how the PCCP will fit within the total product life cycle of the device. Manufacturers should review their Quality System (QMS) to understand how a PCCP would be integrated and operationalized. In particular, manufacturers need to determine how the review and approval for modifications to device design and production will be completed and documented (and maintained in the device master record).
It's important to note that the FDA expects any modifications proposed within the PCCP to be verified and validated within the device’s existing quality system so now is the time to figure out if any updates to your QMS are required!
1) Define the scope of modifications
A PCCP is designed to cover changes that would otherwise require a new marketing submission prior to commercialization. However, the FDA has stated that all changes outlined in the PCCP must not change the intended use and/or indications for use. Modifications that are intended to maintain or improve the safety or effectiveness of the device should be considered.
The FDA has provided the following examples of modifications that may be considered acceptable.
- Modifications related to quantitative measures of ML-DSF performance specifications
Example: Improvements to analytical and clinical performance resulting from re-training the ML model based on new data within the intended use population from the same type and range of input signal. - Modifications related to device inputs to the ML-DSF
Example: Expanding the algorithm to include new sources of the same signal type (e.g., different makes, models, or versions of a data acquisition system) or limited modifications related to new types of inputs. - Limited modifications related to the device’s use and performance (e.g., for use within a specific subpopulation)
Example: Authorization of a device for a specific subset of a population within the originally indicated population based on re-training on a larger data set for that subpopulation that was not previously available.
Manufacturers should pull together cross-functional representatives from Quality, Regulatory, R&D, and Marketing to develop the list of modifications to be considered for inclusion in the PCCP. It may be helpful to look at past device performance and changes to prior versions of the device or predicate devices to develop the list of modifications to include in the PCCP.
2) Outline how modifications will be achieved
Once the list of modifications has been developed, manufacturers need to determine the methods that will be followed when developing, validating, and implementing the proposed modifications.
The FDA expects the following to be outlined for each proposed modification:
- Data management practices
- Re-training practices
- Performance evaluation protocols
- Updates to procedures (including communication and transparency to users and real-world monitoring plans)
There is some latitude for manufacturers to include other or additional components if their proposed protocols do not fit into one of those categories. The level of detail may also vary between modifications based on complexity and risk. The FDA draft guidance also contains detailed questions (6 pages of them!) that should be addressed within each section.
3) Determine the impact of modifications
Within the device manufacturers existing quality system, an impact assessment needs to be conducted for the proposed modifications. Like any change to the device, the impact assessment is intended to document the benefits and risks as well as any required risk mitigations.
Manufacturers should again pull together cross-functional representatives from Quality, Regulatory, R&D, and Marketing to help understand the impact of:
- Each proposed modification versus the device without modifications
- Each modification on the other modifications
- Collective impact of all the modifications
It’s important to incorporate an impact assessment as early in the development process as possible since additional required risk mitigations may be identified.
4) Document the PCCP
In an ideal world, your team has implemented documentation practices throughout, but product development is rarely a linear process. Perhaps documentation started with a spreadsheet or powerpoint to facilitate brainstorming and collaboration but now a PCCP needs to be ready for a marketing submission. The FDA expects the PCCP to be a standalone section within the marketing submission and a controlled document in alignment with Quality System regulations.
5) Include the PCCP in your FDA submission
Once the PCCP is documented, the FDA encourages manufacturers to leverage the Q-Submission process for obtaining FDA feedback on a proposed PCCP prior to submitting a premarket submission.
Once the PCCP is ready to be included in a marketing submission, the FDA draft guidance outlines expectations on how to incorporate it in the overall submission:
- PCCP should be included and discussed in the cover letter
- PCCP should be included within the premarket submission’s table of contents as “Predetermined Change Control Plan”
- PCCP should be discussed within the following sections of the premarket submission:
- Device Description
- Labeling
- Relevant sections used for determining substantial equivalence or reasonable assurance of safety and effectiveness
- Any information pertaining to the PCCP content included outside of the PCCP section should be referenced within the PCCP section.
Get started with Cosm's PCCP template
We've created a straightforward PCCP template to save you time and resources in creating a PCCP. It’s in Word format and includes instructions and tips on how to create the plan, along with details on content to include based on the FDA’s guidance.
Looking for one-on-one help with your PCCP?
Are you short on time and need someone to create a PCCP for you? Our expert team can help you create and operationalize a PCCP within your current quality system. Shoot us an email and let's chat.
