FDA ASCA Program FAQ (English)
Rapid product evolution brings more complex, connected medical devices to market each year. As a result, the FDA is working to advance the regulatory review process to demonstrate medical devices’ safety and effectiveness before being sold and used.
The FDA introduced the Accreditation Scheme for Conformity Assessment (ASCA) pilot program to help ensure that patients have timely and continued access to safer, effective and high-quality medical devices. Due to the complexities, many manufacturers don’t have a clear understanding of the benefits of participating in this pilot program or how it will impact their products’ compliance with FDA standards for medical devices.
Download UL Solutions' curated FAQ to gain access to helpful information and resources to understand the ASCA program better and help streamline your submission process.