The FDA issued a draft of guidance for PCCP for AI-enabled devices on April 3, 2023, followed by a draft guidance for PCCP for all medical devices in August 2024, and a final guidance for PCCP in December 2024. PCCP is a great tool for continued innovation while reducing regulatory burden and time delays due to repeat submissions. This is especially beneficial for diagnostic and software-based products with frequent changes, where continued algorithm training improves performance and fosters innovation. This also enables the use of Real-World Data (RWD) for model retraining or validation as part of the modification plans.
Tracing PCCP back further to December 2022, the Food and Drug Omnibus Reform Act (FDORA) was signed into law with the aim of modernizing FDA regulations and processes across several areas including drug development, device regulation, and patient access to treatments. The act was brought on with the intention of updating regulatory pathways to incorporate modern scientific tools, technologies, and approaches. Section 3308 of FDORA explicitly addresses the need for PCCPs to manage post-market updates to medical devices, including AI/ML-enabled devices.
When it comes to effectively implementing PCCP into industry, planning and thinking ahead are paramount to a company’s success. Organizations with a robust planning culture are in a great position to benefit from this tool. PCCPs are submitted as a part of marketing submissions and are authorized as a part of marketing authorizations such as 510(k), de novo, or PMA. With proper planning of potential changes and how they would impact a submission, the chance for a required resubmission falls drastically. To further increase the likelihood of successful implementation, it is recommended that the potential PCCP be discussed as a part of the Q-submission process.
Potential changes include but are not limited to:
Any deviation from the authorized PCCP may trigger review and regulatory repeat submissions. Any modifications as per authorized PCCP could be documented as part of the quality system without going through additional regulatory submissions. Implementing proper planning and design control will facilitate the implementation of an effective PCCP process, reducing significant regulatory burden and expediting time to market. Additionally, in January 2025, the FDA issued a draft guidance for Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendation. This document further emphasizes TPLC (Total Product Life Cycle), Design Control, and PCCP. Going forward it is highly recommended that these guidance's be considered an essential part of the product development plan & process, especially if the device in question is based on software.
David Heffelfinger joined AltaQ in December 2017. Prior to AltaQ he was Site Manager & Senior Director of Engineering for QIAGEN. As VP Engineering at PrimeraDx (acquired by QIAGEN), David contributed to a highly successful 501K submission and clearance by the FDA. In addition, he was an engineering executive at Beckman Coulter, BD Biosciences, and Bio-Rad Laboratories as well as at several startups and venture capital-backed companies including Biometric Imaging, Alpha Innotech Corp, and Luminys Systems. Dave was also a founder of his own company, Hyperspectra LLC. He has a B.S./M.S. in Physics from Wayne State University and an M.B.A. from Saint Mary’s College (Moraga CA).
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Zain earned his BS in Bioengineering from Northeastern University in Boston. He also received the Designing and Building AI Products and Services certificate from the Massachusetts Institute of Technology (MIT).
Zain completed Engineering Co-Ops with EyeCool Therapeutics and Suono Bio where he supported clinical and product development.
Zain is pursuing his Master’s degree in Molecular Engineering at the University of Chicago.
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Fayyaz Memon has over 30 years of regulatory, quality and clinical experience in the IVD/LDT, medical device, and biotech industries. Fayyaz held progressive roles at a number of companies, including Natera, Biological Dynamics, Asuragen, Qiagen, PrimeraDx, ThermoFisher, Innovative Neurotronics, Digene, Pfizer, and J&J.
He has built a unique professional portfolio combining his QA/RA expertise with clinical, manufacturing, software, operations, and project management experience. He has a successful track record in guiding multiple companies to achieve regulatory approvals and successful commercialization.
Fayyaz has completed regulatory projects in the USA, Europe, and Asia. Fayyaz received his M.S. in Engineering and his M.B.A. from Drexel University.
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David Liu has over 12 years of quality and regulatory experience in the IVD/LDT and medical device industries. Prior to AltaQ, David established the quality department at Biological Dynamics and successfully obtained ISO 13485 certification. David contributed towards technical files for successful regulatory submission as well as FDA breakthrough device designation. He has a B.S in Chemistry from UNC-Chapel Hill and a PhD in Chemistry from University of Florida.
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