The call for abstracts for the MTI Regulatory Intelligence and Networking Summit is now open. The Summit, which will be held June 3-5, 2024, Washington, DC, offers education and discussion for the Medtech community as it works to develop processes, procedures and solutions to streamline global and product lifecycle regulatory compliance.
The National Institute of Standards and Technology (NIST) is seeking input from industry to support its response to President Biden’s Executive Order on AI. Comments, which are due February 2, 2024, will help NIST develop guidelines for evaluation and red-teaming, consensus-based standards and more.
The pilot program launched by Baxter International and Northwestern Medicine in Chicago resulted in the recycling of more than 170,000 IV bags. Baxter is now working to expand the program in the Chicago area to further validate the process and economic viability of the program.
A recent survey by the AMA showed that practicing physicians are equally excited and concerned about the increased use of AI in health care, with enthusiasm for technologies that reduce administrative burden and enhance diagnostic ability and concern for patient privacy, liability and erosion of the patient-physician relationship.
Companies have several avenues available to share their input on and help shape MedTech regulation. At the 2023 MedTech Regulatory Intelligence Summit, former FDA CDRH member Steven Silverman, and Patterson Shafer, strategic advisor to FDA, offered guidance on how to establish credibility with FDA and the most effective ways to make your voice heard.
The draft guidance includes regulatory context in which use of real world evidence (RWE) may be appropriate, general considerations for the use of RWE, guidance on assessing data relevance and reliability, and considerations for methodologies for collection and analysis of real world data (RWD) to generate RWE.
Peter J. Arduini, president and CEO of GE HealthCare, began his two-year term as Board Chair last Friday. The same day AdvaMed announced its new Medical Imaging Division under the direction of Patrick Hope, former executive director of the Medical Imaging & Technology Alliance.
The FDA is seeking representatives to join the Genetic Metabolic Advisory Committee, which will advise the agency on products used for the diagnosis, prevention or treatment of genetic metabolic diseases under the purview of the Division of Rare Diseases and Medical Genetics.
Karandeep Badwal, consultant and president of QRA Medical, discusses the change in focus from EU MDD to EU MDR, and how companies will need to adapt to meet new reporting requirements and maintain compliance in the European market.
On November 27, the FDA announced that it is no longer a member of the Global Harmonization Working Party (GHWP) but will continue its outreach to global partners and its efforts to ensure alignment of medical device international harmonization by working with the International Medical Device Regulators Forum (IMDRF).
