Regulatory Focus™

US, Canadian and British regulators have published a list of guiding principles that medtech developers should consider when developing artificial intelligence/machine learning (AI/ML) products that use predetermined change control plans (PCCP).

HTAR states the JCA report 'should be factual and should not contain any value judgment.” Assessments of the certainty of study results must remain descriptive at the European level and avoid conclusions that may interfere with independent decision-making at the national level.

The US Food and Drug Administration (FDA), Health Canada, and the UK Medicines and Healthcare products Regulatory Agency (MHRA) have released additional guiding principles for machine learning-enabled medical devices (MLMDs) that focus on transparency of information for stakeholders that interact with the device.

The International Medical Device Regulators Forum (IMDRF) has published guiding principles for artificial intelligence/good machine learning (AI/ML) practices in medical device development that are identical to a 2021 document published by US, UK, and Canadian regulators.

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have agreed to a set of guiding principles for their staff when using large language models (LLM) to make regulatory decisions. Artificial intelligence (AI) virtual assistants or chatbots use LLMs to formulate results, and the agencies foresee regulators using such technology in their work.

The Alliance for Regenerative Medicine's (ARM) Gene Editing Task Force on Tuesday released a set of principles for human genome editing endorsed by thirteen of its members who are involved in the development of gene therapies or gene-editing technology.

The European Commission has released a draft implementing regulations on joint scientific consultations under the Health Technology Assessment (HTA) Regulation. The draft implementing regulation covers medical devices and IVDs.

The Healthcare and Public Health Sector Coordinating Council (HSCC) released a new medical device and health IT joint security plan (JSP) Monday to serve as a reference guide for strengthened cybersecurity.

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

The European Medicines Agency (EMA) has updated its user guide for small and medium enterprises (SME) based on new requirements coming into effect under the EU Medical Devices Regulation (MDR). It touches on issues such as clinical trial requirements, use of the agency's IT systems, addresses products with regulatory framework uncertainty, and more.

The document, which was issued by the US Food and Drug Administration (FDA), Health Canada, and the UK's Medicines & Healthcare products Regulatory Agency (MHRA), is aimed at informing the work of the International Medical Devices Regulators Forum (IMDRF) and other international standards organizations as they tackle regulation of a growing number of medical devices that incorporate machine learning and artificial intelligence.

The European Commission has posted a draft implementing regulation that sets out detailed procedural rules for joint scientific consultations under the Health Technology Assessment Regulation (HTAR).