With Artificial Intelligence penetrating the pharma world at a rapid pace, three regulators have joined forces with the aim of fostering Good Machine Learning Practice (GMLP).
The US FDA, UK’s Medicines and Healthcare products Regulatory Agency, and Health Canada | Santé Canada have come together to release a set of 10-founding guidelines which they believe will support the development and maturation of the tech as it becomes ever more prevalent across the industry.
The “Good Machine Learning Practice for Medical Device Development: Guiding Principles” aims to help promote safe, effective, and high-quality medical devices that use artificial intelligence and machine learning (AI/ML) and are a great first step in setting standards for this key area.
These initial 10 guiding principles identify areas where the International Medical Device Regulators Forum (IMDRF), International standards organizations and other collaborative bodies could work to advance GMLP. Areas of collaboration include research, creating educational tools and resources, international harmonization, and consensus standards, which may help inform regulatory policies and regulatory guidelines in the years to come.
As the AI/ML medical device field evolves, so too must GMLP best practice and consensus standards. As avid believers that the advancements brought from such technologies should be embraced, QUINTA-ANALYTICA, who have previously featured how progress in this area is being felt in their labs and across their business, celebrate this solid step forward and hope it attracts further collaboration from more industry bodies.
Find out more about the guidelines on fda.gov, and read more about Quinta and how they utilize the latest and greatest technology right here at Quinta.cz
November 18, 2021