US FDA IVD Classification System: A Comprehensive Guide
In vitro diagnostics (IVDs) have a vital role in improving patient outcome and public health surveillance. IVDs are used to detect diseases, monitor health conditions, guide treatment decisions, detect diseases early on, and support precision medicine. Hence, IVDs...
US FDA Regulatory Pathways for New Medical Devices
US FDA has stringent regulations for medical devices entering the US market. For launching a new medical device in US, you need to mandatorily comply with all FDA medical device regulatory guidelines. Additionally, you need to secure the applicable approval type for...
What is the difference between US FDA 510(k) and PMA? A Guide
All medical devices entering the US market must comply with the regulatory requirements formulated by US FDA. These regulatory requirements are in place to ensure safe, effective, and high-quality medical devices reach the patients. The regulatory pathway required...