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Explore the US FDA’s ASCA Program

Learn about the U.S. Food and Drug Administration’s (FDA) Accreditation Scheme for Conformity Assessment (ASCA) pilot program and why medical device manufacturers should consider participating.

To help ensure that patients have timely and continued access to safer, more effective and high-quality medical devices, the U.S. Food and Drug Administration (FDA) introduced the Accreditation Scheme for Conformity Assessment (ASCA) pilot program. Many manufacturers do not have a clear understanding of the benefits of participating in this pilot program and how it will impact their products’ compliance with FDA standards for medical devices.

Download our detailed checklist to learn about the program and why medical device manufacturers may want to consider participating.

Download the checklist
FDA

FDA ASCA Program Checklist (English)

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