MedPath

FDA Finalizes Guidance on Predetermined Change Control Plans for AI-Enabled Medical Devices

• The FDA has finalized guidance on predetermined change control plans (PCCPs) for AI-enabled medical device software functions, aiming to streamline iterative development. • PCCPs allow developers to plan for modifications to AI-enabled devices while ensuring safety and effectiveness through a structured methodology for validation and implementation. • The guidance specifies that changes consistent with an approved PCCP do not require a new 510(k) submission or a PMA supplement, reducing regulatory burden. • While focused on AI-enabled devices, the FDA indicates that PCCPs can be applied to other types of medical devices, with broader draft guidance available.

The Food and Drug Administration (FDA) has issued final guidance on predetermined change control plans (PCCPs) for artificial intelligence (AI)-enabled medical device software functions. This guidance aims to provide a framework for managing modifications to these devices while maintaining reasonable assurance of safety and effectiveness.
The FDA recognizes that AI-enabled device development is an iterative process. PCCPs are designed to allow developers to plan for modifications, ensuring continued safety and effectiveness. A PCCP should include planned modifications, a methodology to develop, validate, and implement these modifications, and an assessment of their impact.
The concept of PCCPs was initially introduced in a 2019 white paper and further solidified by the Food and Drug Omnibus Reform Act of 2022 (FDORA). FDORA stipulates that a supplemental application for a device that received Pre-Market Approval (PMA) or a new 510(k) is not required for a change to a device if the change aligns with an FDA-approved or cleared PCCP.
This final guidance is specifically tailored to AI-enabled devices. However, the FDA notes that PCCPs can be submitted for other types of devices. The FDA has also issued draft guidance that applies more broadly to all devices, indicating a wider applicability of the PCCP concept.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

FDA Approves PTC Therapeutics' Gene Therapy Kebilidi for AADC Deficiency

The FDA has approved eladocagene exuparvovec-tneq (Kebilidi), a gene therapy developed by PTC Therapeutics, for treating AADC deficiency in adult and pediatric patients.
Kebilidi is the first FDA-approved gene therapy for AADC deficiency, a rare genetic disorder affecting neurotransmitter production and causing severe developmental delays.

FDA Approves AI Tool for ARIA Detection, Expands Nerivio Indication, and Grants Accelerated Approval to Gene Therapy for AADC Deficiency

The FDA cleared icobrain aria, the first AI software to detect and grade amyloid-related imaging abnormalities (ARIA) in Alzheimer's disease, enhancing patient safety during anti-amyloid treatments.
Theranica's Nerivio receives expanded FDA approval for acute migraine treatment in patients aged 8 and older, offering a needle-free, non-drug alternative for pediatric migraine.

FDA Advisory Committee Emphasizes Patient-Centered Informed Consent in Clinical Trials

FDA's Patient Engagement Advisory Committee (PEAC) convened to enhance patient understanding and engagement in clinical trials, advocating for shared decision-making.
The committee highlighted gaps in real-world consent processes, emphasizing the need for patient-centric approaches and accessible materials to improve participant comprehension.

FDA Approves PTC Therapeutics' KEBILIDI, a Gene Therapy for AADC Deficiency

The FDA has granted accelerated approval to KEBILIDI (eladocagene exuparvovec-tneq), a gene therapy for AADC deficiency, marking the first FDA-approved gene therapy directly administered to the brain.
KEBILIDI is indicated for both children and adults with AADC deficiency, addressing the full spectrum of disease severity and offering a new treatment option for this rare genetic disorder.

FDA to Release Guidance on AI Use in Drug Development Amidst Rapid Technological Advancements

The FDA is expected to release new guidance by year's end on the use of AI in clinical trials and drug development to address rapid technological advancements.
AI's potential to improve drug efficacy, optimize dosing, and predict adverse effects is balanced against concerns about data quality, transparency, and patient safety.

AMC Health Receives FDA Clearance for AI-Powered Virtual Care Platform

AMC Health secured its third FDA 510(k) clearance for its virtual care and clinical decision support solution, marking it as a Class II medical device.
The clearance covers both the clinician dashboard and patient mobile app, enabling hospital-level, acute-care-at-home and continuous monitoring.

AMC Health Gains FDA Clearance for AI-Powered Virtual Care Platform

AMC Health received FDA 510(k) clearance for its virtual care and clinical decision support solution, marking its third such approval.
The clearance covers both the clinician dashboard and patient mobile app, enabling hospital-level acute-care-at-home and continuous monitoring.

FDA Finalizes Guidance on Electronic Records in Clinical Trials

The FDA has finalized guidance addressing questions about using electronic records and signatures in clinical trials, aiming to modernize data collection and management.
The guidance clarifies FDA's expectations for electronic systems, ensuring data integrity, reliability, and participant safety in clinical investigations.

FDA Clarifies Post-Approval Changes and New Indications for Biosimilars

The FDA has clarified guidelines for post-approval changes to biosimilars, including manufacturing process modifications and quality control adjustments.
Biosimilars can now pursue new indications not included in the reference product's license without being classified as a new biological drug.

FDA Expands Access to Investigational Drugs for Treatment Use

The FDA has finalized a rule to expand access to investigational drugs for patients with serious or immediately life-threatening diseases or conditions who have no comparable or satisfactory alternative therapy. This rule aims to increase awareness and knowledge of expanded access programs, detailing criteria, submission requirements, and safeguards for different types of expanded access.

Reference News

[1]
FDA Finalizes PCCP Guidance for AI-Enabled Medical Devices - Akin Gump
akingump.com · Dec 4, 2024

FDA issued final guidance on predetermined change control plans (PCCPs) for AI-enabled device software functions, allowi...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy