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:

The five guiding principles for PCCPs include:

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, 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.