Companion diagnostics (CDx) play a pivotal role in personalized medicine—one of the fastest growing areas of medicine. Regulation of CDx is fairly well established in western countries, but the east is not far behind. Here we look at current and on the horizon regulatory guidances and directives for CDx manufacturers seeking to enter the Asian markets.
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.
“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).
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.
In an era where sustainability is no longer a choice but a necessity, the medical industry finds itself at a crossroads. With the increasing amount of medical waste generated daily, the traditional methods of disposal are proving to be inadequate and environmentally detrimental. Enter the world of Smart Disposal Systems, where the Internet of Things (IoT) is revolutionizing the way we handle medical waste.
Megan Coder, Vice President for Product and Policy at the Digital Medicine Society (DiMe), discusses the society’s new project aimed at researching global regulations for digital health to create a foundation for approval and patient access that can cut across regions.
The FDA announced that on October 1, 2023, it would begin to Refuse to Accept (RTA) medical device premarket submissions that do not comply with PATCH Act requirements. Erez Kaminski, former head of AI with Amgen and founder of Ketryx, and Paul Jones, former FDA official and Executive Vice President of Ketryx, provide an overview of challenges companies face as they work to comply with the new cybersecurity regulations and standards.
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions provides recommendations on what information to include in premarket submissions and emphasizes that cybersecurity is a component of quality system regulation.
The updated guidance clarifies how the program applies to medical devices that may address health inequities, as well as those that may increase access to care or provide a non-addictive treatment option to treat pain or addiction. It also clarifies the FDA’s current interpretation of the Breakthrough Device designation criteria.