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Expect Future FDA Clarification on Machine Learning-Enabled Medical Devices


The inaugural AAMI/FDA neXus medical device standards conference was held February 20-23, 2024 in Washington DC. The conference was hosted by the Association for the Advancement of Medical Instrumentation (AAMI). Additional information regarding the conference can be found here.

Jessica Paulsen, the associate director for digital health at the Office of Product Evaluation and Quality (OPEQ) at the Center for Devices and Radiological Health (CDRH) of the FDA spoke on February 21, 2024 at the conference. Paulsen spoke on the FDA’s Predetermined Change Control Plans (PCCPs) and how future guidance could be issued this year, as reported by the Regulatory Affairs Professional Society (RAPS).

The PCCPs five guiding principles were jointly developed by the FDA, Health Canada, and the U.K.’s Medicines and Healthcare Products Regulatory Agency. The guiding principles relate to the change management process to help ensure the ongoing safety and effectiveness of artificial intelligence/machine learning-enabled medical devices (MLMD).

The FDA’s guidance states that the term PCCP describes a plan, proposed by a manufacturer, that specifies: certain planned modifications to a device, the protocol for implementing and controlling those modifications, and the assessment of impacts from modifications.

According to the FDA:

“One key objective of the 5 Guiding Principles for PCCPs for MLMD is to provide foundational considerations that highlight the characteristics of robust PCCPs. Another objective of this document is to facilitate and foster ongoing engagement and collaboration among stakeholders on the PCCP concept for MLMD.”

The five guiding principles for PCCPs include:

Focused and Bounded: A PCCP describes specific changes that a manufacturer intends to implement. Such changes are limited to modifications within the intended use or intended purpose of the original MLMD.

Risk-based: The value and reliability of a PCCP is strengthened when the intent, design, and implementation of a PCCP are driven by a risk-based approach that adheres to the principles of risk management.

Evidence-based: Evidence generated throughout the TPLC of the device is important to … ensure the ongoing safety and effectiveness of the device with a PCCP; demonstrate that the benefits outweigh the associated risks and; establish that the risks are adequately managed and controlled.

Transparent: For PCCPs, the best practice is to provide clear and appropriate information and detailed plans for ongoing transparency to users and other stakeholders. This helps ensure that stakeholders stay aware of the device’s performance and use before and after changes are implemented.

Total Product Lifecycle (TPLC) Perspective

More details on the FDA’s guiding principles for the PCCPs for Machine Learning-Enabled Medical Devices can be found here.

RAPS reported on Paulsen’s discussion. RAPS stated, “[w]hile PCCPs were initially considered for products with artificial intelligence/machine learning (AI/ML) capabilities, Congress gave FDA much broader authority to use them under the Food and Drug Omnibus Reform Act of 2022 (FDORA).” Paulsen stated: “[i]t’s really important to remember that PCCP is very specific to a specific device, it is not for the whole class of devices.”

RAPS further stated:

“Paulsen said that FDA is still figuring out the limits of their authority and they plan on issuing final and draft guidances this year to help clarify what those limits are.”

Paulsen, other speakers, and other attendees participated in the discussion. Based on RAPs reporting, the discussion appears to have focused on how the guiding principles should be or could possibly be interpreted.

In view of Paulsen’s discussion, further guidance from the FDA regarding PCCPs should be expected.

More on the conference and Paulsen’s discussion regarding the FDA’s PCCPs can be found here.


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Paige Cappelli

Paige Cappelli primarily focuses on patent prosecution and patent litigation in the mechanical and medical device areas.

Paige graduated magna cum laude from Temple University Beasley School of Law. While attending Temple University, Paige served as President of the Intellectual Property Law Society. Prior to law school, Paige received her BS in Industrial Engineering from California Polytechnic State University, San Luis Obispo.

Paige worked as a summer associate at the firm in 2019 and joined the firm in 2021.

View all posts published by Paige Cappelli
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