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...
Secure US FDA 510(k) Approval for IVDs in a Hassle-free Manner
The US FDA 510(k) approval process authorizes the marketing of IVDs in the US. Through this process the Food and Drug Administration (FDA) evaluates device safety and effectiveness before releasing it in the market. Hence, compliance with US FDA...