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Within UL Solutions we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Approved/Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brand, we have processes in place to identify and manage any potential conflicts of interest and maintain impartiality. UL Solutions is unable to provide consultancy services to EU MDD, MDR or IVDD Notified Body, UKCA MD Approved Body or MDSAP Customers.
  • Checklist

Explore the US FDA’s ASCA Program

Learn about the U.S. Food and Drug Administration’s (FDA) Accreditation Scheme for Conformity Assessment (ASCA) 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) program. Many manufacturers do not have a clear understanding of the benefits of participating in this 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

Thumbnail - FDA ASCA Program Checklist (English)

FDA ASCA Program Checklist (English)

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