By: Elle Winn (Mittal Consulting) At 12:01 am ET on Wednesday, October 1, 2025, the US federal government began its government shutdown. With this shutdown, many are asking what it means for FDA operations, and especially the impacts on the medical device industry during this closure. For the Center for Devices and Radiological Health (CDRH), […]
By- Mridul Mittal, Co-founder & COO, Mittal Consulting Celebrating 5 Incredible Years of Mittal Consulting! What started during the uncertain days of the global pandemic has grown into a powerful, purpose-driven force within the medical device industry. Today, as we proudly celebrate 5 incredible years of Mittal Consulting. We reflect on a journey defined by […]
By: Anya Bekhtel (Mittal Consulting) FDA Launches Regulatory Accelerator to Empower Digital Health Innovators On July 24, 2025, the U.S. Food and Drug Administration (FDA) unveiled Regulatory Accelerator, an initiative intended to empower innovators on the journey of bringing digital health products to the US market. Regulatory Accelerator: A Centralized Resource for Success Regulatory Accelerator […]
By- Elle Winn (Mittal Consulting) March 12-13, 2025 Palo Alto Regulatory Shifts and Industry Insights The Medical Device Manufacturers Association (MDMA) hosted their annual FDA Forum on March 12-13, 2025 in Palo Alto, California. While FDA attendance was limited due to recent return-to-office (RTO) and budget policies, the event still brought in many industry members […]
17 February, 2025 Under the new US administration, there are rigorous changes, and we are already seeing direct impacts to all FDA branches, but disproportionately FDA device’s review branch, Center for Devices and Radiological Health (CDRH). In order to plan how to best adapt to these changes, we’d first like to present the changes that have […]
By: Elle Winn (Mittal Consulting) Exploring the Future of AI Medical Devices: FDA’s Predetermined Change Control Plan Offers Potential, but Challenges Remain Artificial Intelligence (AI) is continuing to grow at an awe-striking rate. As the artificial intelligence ecosystem continues to develop, we should expect to see AI continue with strong penetration into the med-tech sector. […]
Quite often, medical device executives are apathetic towards biocompatibility testing, rightfully questioning, “So what?” and trying to delay it as much as possible. However, postponing biocompatibility testing too long may lead to financial loss and even further delays in the commercialization of the medical device. Therefore, it is most advantageous for medical device companies to […]
-Shu Xiang (Regulatory Affairs Specialist, Mittal Consulting) House Committee Advances Bill for CMS Coverage of Breakthrough Medical Devices A bill that would mandate the Centers for Medicare and Medicaid Services (CMS) to provide expedited temporary Medicare coverage of breakthrough medical devices cleared the House review committee, pushing it further along the legislative path. The Breakthrough […]
Elle Winn What is EtO Sterilization? Ethylene Oxide (EtO) gas sterilization is one of the most common sterilization methods used for medical devices. The practice is critical to sterilizing temperature- or moisture-sensitive devices1 and is very efficient for sterilizing devices with complex geometries with limited access2. For some devices, EtO gas sterilization is the only […]