AAMI and the British Standards Institute (BSI) have jointly published new guidance documents on performing risk management for machine learning or artificial intelligence incorporating medical devices.
The regulatory landscape for medical devices is rapidly evolving, catapulted most recently by European Union Medical Device Regulations (EU MDR). In this article, Monica Bhansali, Practice Lead of Regulatory Affairs at Tata Elxsi, highlights challenges and advancements in the MedTech regulatory landscape, and what the future has in store.
Medtech companies can receive up to $300,000 for the adoption of advanced manufacturing technologies through the MDIC Advanced Manufacturing Clearing House. The program is designed to speed adoption and provide guidance for industry and the FDA on the most beneficial applications of advanced technologies.
The FDA has updated the CDRH portal to allow users to track the progress of their pre-submissions. As of October 23, 2023, all 510(k) submissions, unless exempted, must be submitted as electronic submissions using FDA’s eSTAR portal.
Regulatory requirements for computer systems validation (CSV) have long been in place, but their compliance requires considerable time and resources. In the life sciences industry, traditional validation processes add to project timelines and costs, affecting time to market and preventing the deployment of newer versions of software. In addition to improving accuracy and coverage, automated CSV processes can create the same artifacts as manual execution and expedite the upgrade timeline.
The FTC argues that the $27.8 billion transaction would enable Amgen to use rebates on its existing blockbuster drugs to stifle competition for Horizon’s two monopoly products for thyroid eye disease and chronic refractory gout.
Dr. Bertagnolli is a surgical oncologist, cancer researcher, educator, and current director of the National Cancer Institute (NCI). She previously served as the Richard E. Wilson Professor of Surgery in the field of surgical oncology at Harvard Medical School, a surgeon at Brigham and Women’s Hospital, and a member of the Gastrointestinal Cancer Treatment and Sarcoma Centers at Dana-Farber Cancer Institute.
“Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products” and “Artificial Intelligence in Drug Manufacturing” were developed to support the use of AI/ML while addressing concerns related to security, bias and risk, and spur feedback and discussion from stakeholders.
The draft guidance covers DCT design, informed consent, the use of remote clinical trial visits, safety monitoring and software used in conducting DCTs for drugs, biological products, and devices. The comment period is open until August 1, 2023.
There are several tactical approaches to design that can help medtech manufacturers inspire patient confidence in their products and ensure proper usage. Following are three ways you can help ease the burden of delivering and receiving quality care through product design.
