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.
“We’re excited to have Naomi in this role. With her FDA experience, her visionary approach will pave the way for success, ensuring that businesses not only meet the FDA’s stringent requirements but also thrive in an environment where cybersecurity is a fundamental business value.”
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.
In addition to addressing cybersecurity risk management during the design and development of medical devices, the standard also contains clear guidance related to postmarket monitoring of device vulnerabilities, security measures such as patching, and the use of a software bill of materials.
The MedTech Regulatory Intelligence Virtual Summit offers informational sessions and panel discussion on the current focus of FDA CDRH, European and Asian Markets, and Strategies to Streamline Your Regulatory Operations, delivered over three days on November 13-15. Join from your home or office and include your entire regulatory team.
On October 30, President Biden issued an Executive Order establishing new standards for artificial intelligence (AI). The order focuses on safety and security, privacy protections, advancement of equity and civil rights, promotion of innovation and competition and advancing American leadership in AI.
The goal of the collaboration is to optimize the benefits of PCCPs by supporting predictability and harmonizing regulatory considerations across jurisdictions, and ultimately, put safe and effective advancements in the hands of healthcare providers and users faster.
The committee will advise the Commissioner of Food and Drugs on issues related to Digital Health Technologies (DHTs), and FDA policies and regulations about these technologies, providing relevant expertise and perspective to improve the FDA’s understanding of the benefits, risks and clinical outcomes associated with use of DHTs.
