iwewlkws While there have been numerous discussions by regulators worldwide, particularly the FDA and European Medicines Agency (EMA), about the regulation of devices based on Artificial Intelligence (AI), there have not been any specific rules, till this week. The EU published the first formal regulation for AI this week to lay down a uniform legal framework … Read more
The Centers for Medicare & Medicaid Services (CMS) announced a new program to provide coverage to medical devices approved under the Breakthrough Device program. Most breakthrough devices are approved with limited safety and efficacy data and it would be hard to secure coverage under the conventional review process. The new program is designed to address … Read more
In the last 10 years, the FDA has approved about a thousand medical devices containing Artificial Intelligence/Machine Learning (AI/ML) algorithms. Although the devices cover diverse indications and types, there are some interesting regulatory trends to be considered for those developing a new AI/ML device. The number of AI/ML devices approved by the FDA has steadily … Read more
The Health Equity discussion with the regulated industry has been heavily weighted towards drugs and biologics. However, lack of diversity is an issue for medical device clinical trials as well. The FDA listed several considerations in its discussion paper this week on the topic aiming to collect feedback from the device industry and other stakeholders … Read more
There is a significant misunderstanding about what is acceptable Real World Evidence (RWE) to support market approval applications for regulated products by the FDA. Is published literature acceptable, or is it clinical experience with marketed products, what is the weight of patient-reported outcomes, or is it only data from medical records, and so on? Apparently, … Read more
The FDA has an office dedicated to studying the safety of medications. In its annual report, the Office of Surveillance and Epidemiology (OSE) listed a summary of its activities last year. The most prominent information is the increased use of Artificial Intelligence (AI), Machine Learning (ML), and Natural Language Processing (NLP) tools to help with … Read more
The primary concerns with the safe and effective use of AI-enabled medical devices are their trustworthiness, fairness, and performance. The FDA proposes a lifecycle management (LCM) approach to better address these concerns. This week, a series of blog posts by the FDA’s office leading review of software medical devices (SaMDs) describes an AI life cycle … Read more
Since August 2017, the FDA has released 11 guidance documents describing various aspects of real world data (RWD) and real world evidence (RWE) in regulatory decision-making. The 12th guidance document released this week describes expectations from clinical studies that use RWD sources, Electronic Health Records (EHRs), and medical claims data, to derive RWE. This guidance, … Read more
There are more than 20 FDA guidance documents on various types of FDA meetings with the sponsors which can be confusing because similar information is repeated across multiple documents. On the other hand, the FDA’s internal processes for managing meeting requests highlight a unified FDA approach to different meetings. How does the FDA staff process … Read more
Post-market pharmacovigilance could be improved to collect robust data from the use of products to generate data acceptable to regulatory agencies for new claims for the safety of the products. A new ICH guidance describes various parameters to plan for which would create such robust data. Post-market use is “free” data that could help companies … Read more
