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...
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...
An 8-Step Guide to Selecting a US FDA agent for Your Company
A U.S. FDA agent is a designated representative required for foreign companies that manufacture, process, or distribute FDA-regulated products. These products, such as medical devices, drugs, or food, should be intended for import into the United States. We have...