The draft guidance includes regulatory context in which use of real world evidence (RWE) may be appropriate, general considerations for the use of RWE, guidance on assessing data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).
The NeuroAccess technology employs focused ultrasound in combination with microbubbles to open the blood-brain barrier in a safe, temporary and noninvasive manner.
The guidance provides a framework that manufacturers can use to show that physics-based or mechanistic computational models used to support regulatory submissions are credible.
Companies must now electronically submit all FDA 510(k) submissions using the eSTAR platform. Dr. Dhriti Roy, vice president of Regulatory Affairs Transformation at Essenvia and faculty at Oxford University’s MedTech innovation platform, highlights the benefits and challenges of eSTAR, as well as processes and tools companies need to adopt as they transition to this new submission process.
AI-driven regulatory platforms support SaMD organizations by proactively monitoring and adapting to the dynamic global regulatory landscape. The technology alerts users to anticipated regulatory updates worldwide, facilitating improved foresight and trend detection. It also provides guidance on addressing potential lapses in product compliance, integrates with existing workflows and streamlines regulatory tasks from classification to registration and market entry.
Behavioral health providers were excluded from the 2009 HITECH Act, which contributed to significant disparities in EHR adoption between mental and physical health providers. The Behavioral Health Information Technology (BHIT) Coordination Act could help remedy this, yet regulatory and societal barriers to full interoperability remain.
