The UK is an appealing market for MedTech businesses, but there are some important issues that companies will need to be familiar with to ensure they fully understand the UK regulatory landscape. The role of the UK Responsible Person is one of the most important.
Device manufacturers may see the EU MDR extension as an opportunity to take their collective feet off the gas. But slowing down or pausing a device’s testing program could jeopardize a successful transition and exacerbate the problem the deadline extension was designed to fix.
“Content of Premarket Submissions for Device Software Functions” covers recommended documentation sponsors should include in premarket submissions for FDA’s evaluation of safety and effectiveness of device software functions. The agency is hosting a webinar for industry on July 20 to provide an overview and answer questions about the new final guidance.
The FDA is requesting feedback on three new draft guidances related to clinical trials, including how they should be applied to increasingly diverse trial types and data sources.
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.
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The draft guidance covers DCT design, informed consent, the use of remote clinical trial visits, safety monitoring and software used in conducting DCTs for drugs, biological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.
At the 2023 MedCon Conference in April, Michael Maier, VP of Strategic Regulatory and Quality at Veranex, and James Pink, Director of Medical at Element, provided updates on medical device regulation in Switzerland and the UK.
The voluntary program is designed to help companies advance alternative and innovative ways to sterilize approved medical devices, including changing radiation sources, in a least burdensome regulatory approach.
