FDA Issues Predetermined Change Control Plan for AI/ML-Enabled Device Draft Guidance and EPA proposes rules on EtO medical device sterilization
FDA issued a draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions. The document provides guidance for developing a Predetermined Change Control Plan (PCCP) for managing changes to the device software functions. The PCCP is a critical component of the regulatory approval process, as it ensures that changes to the AI/ML algorithms or models, that drive the device software functions are properly validated and verified before being implemented. By developing a robust PCCP that includes risk assessment, performance monitoring, change management, transparency, and early engagement with the FDA, manufacturers can ensure that their products meet regulatory requirements while continuing to deliver effective benefits to their intended users.
The US Environmental Protection Agency (EPA) has proposed two much-anticipated rules that would restrict how much ethylene oxide (also referred to as EO or EtO) medical device sterilizers are allowed to use and release into the environment, and how much of it workers can be exposed to. The agency said its aim is to reduce cancer risk for workers and communities adjacent to EtO sterilization plants. Under the first proposed rule, EPA would require EtO commercial sterilizers to comply with stricter pollution controls under the Clean Air Act (CAA), which would bring their EtO emissions down by 80%. The agency said this rule would affect 86 commercial sterilizers in the US. If finalized, sterilizers would need to comply with the rule within 18 months and report EtO data to the environmental agency twice a year. The second proposed rule is meant to protect workers from significant EtO exposure under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). It gives the agency authority to regulate the use of pesticides including antimicrobial pesticides such as EtO. Specifically, the rule would require reducing the amount of EtO that can be used to sterilize medical devices, require engineering controls to minimize worker exposure to the chemical and would mandate that workers use personal protective equipment (PPE) if EtO inside the facilities exceeds 10 parts per billion (ppb).
The International Medical Device Regulators Forum (IMDRF) released four final guidances this week that address cybersecurity best practices, verification and validation for personalized medical devices and post-market surveillance communication between regulators. The SBOM guidance, published on 13 April, describes what an SBOM is on a “high-level” and includes best practices for medical device manufacturers when developing products. The legacy devices cybersecurity guidance, published on 11 April, focuses on how to apply a TPLC approach to legacy devices. Such devices may present risks to patients as they cannot be sufficiently mitigated using steps such as software updates and may contain insufficient or no security controls. IMDRF also published a guidance on verification and validation of personalized medical devices on 11 April, as well as a guidance on procedures and forms for exchanging post-market surveillance reports between IMDRF members.
FDA is working to finalize its proposal to align its device Quality System Regulation (QSR) with the international standard ISO 13485:2016, creating the Quality Management System Regulation (QMSR). In preparation for the final rule, the agency is readying for the change internally by updating its technology systems, training staff and replacing the Quality System Inspection Technique (QSIT). Regulators did not forecast a specific date for releasing the final rule, noting that it’s slated for publication by December 2023. The regulators also declined to provide an update on whether the one-year proposed implementation timeline is different in the final rule.
The Simbex Regulatory and Reimbursement Recap is a monthly briefing for news in the regulatory and healthcare reimbursement space relevant to Simbex areas of expertise. The briefing is curated by Amaris Ajamil, PhD, RAC, Simbex Director, Quality and Regulatory, and Angela Smalley, PhD, Simbex Senior Product Consultant. A story’s inclusion does not imply endorsement by Simbex.