FDA Breakthrough Device Designation: Criteria & Application
In this blog, we will walk you through FDA breakthrough device designation, its eligibility criteria, and application process. Additionally, we will present the benefits and challenges of the FDA’s breakthrough devices program. What is an FDA breakthrough device? An...
Mandatory EUDAMED implementation from 28 May 2026: How must EU medical device and IVD manufacturers prepare?
European database on medical devices (EUDAMED) is the digital backbone for regulatory oversight across the EU medical device and IVD ecosystem. It has been designed to enhance transparency, traceability, and coordination across EU Member States. EUDAMED will be...
10 Common Reasons for US FDA Submission Denials to Avoid
The U.S. Food and Drug Administration (FDA) serves as the primary regulatory authority for medical devices in the United States. It is responsible for protecting public health. The U.S. FDA accepts several types of submissions depending on the product category, risk...