Thomas Regulatory

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the U.S. Food and Drug Administration authorized the emergency use of certain health products under certain circumstances. Our FDA Emergency Use Authorization EUA consultant is authorized to assist in emergency preparedness and response, including the development and delivery of new or unapproved medical products (drugs, biologics, and medical devices) for use in emergency situations. The Thomas Regulatory Resolution Team supports EUA applications and strategies with a solid understanding of FDA requirements for EUA related to COVID-19; we continue to keep up with changing requirements as they evolve during this emergency due to the current global corona virus pandemic. From providing strategic roadmaps for navigating different EUAs for COVID-19 products to developing commercial use plans for products available under the EUA, the Regulatory Resolutions of Thomas can advise clients on how to achieve their specific short- ...

  The Clinical Evaluation Report (CER) is a detailed summary of the evaluation information relevant to the clinical use of a medical device. All clinical data sources are considered, as well as some nonclinical trial data that may influence the benefit-risk analysis of the device. Taken together, the information contained in the CER provides a thorough understanding of the safety and performance of the device and provides the basis for determining if the device has an acceptable risk-benefit ratio received for its intended use or not. The European Medical Device Registration (MDR) regulatory scenario is extremely dynamic, as are the regulations regarding CER. Therefore, to comply with these regulations and create compliant CERs, companies need to consult with regulatory experts. CER and Mandatory Data Elements General information about the medical device, such as the device's name and manufacturer The device's physical and technical characteristics, as well as its application A...