FDA's ASCA Program

FDA Accreditation Scheme for Conformity Assessment (ASCA) Program

A program for medical device safety and performance testing

A program for medical device safety and performance testing

About the ASCA Program

The ASCA is a voluntary program for all external stakeholders, including accreditation bodies, testing laboratories, and device manufacturers. It aims to reduce the regulatory burden for medical device manufacturers by relying on the product review and testing process that is carried out by the ASCA-accredited laboratory.

The U.S. Food & Drug Administration (FDA) initiated the Accreditation Scheme for Conformity Assessment (ASCA) that emerged from discussions between the institution and the medical device manufacturers. The program was developed by the FDA to make premarketing analyses of in vitro diagnostic (IVD) products and medical devices more consistent and efficient.

Device Standards Covered in The ASCA Program*:

Basic Safety and Essential Performance of medical electrical equipment, medical electrical systems, and laboratory equipment:

Standard Standard Title
ANSI/AAMI 60601-1 Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance
IEC 61010-1 Safety requirements for electrical equipment for measurement,
control, and laboratory use – Part 1: General requirements.

We are accredited for the 60601, electrical testing and plan to add ISO 10993 testing for ASCA in the near future.

*Our approval and acceptance as an ASCA lab is deeper than the base standards listed.

Minimize Time-to-Market for Your Medical Device

By working with an ASCA-accredited laboratory, manufacturers will find the premarket submission to the FDA more agile and convenient. TÜV SÜD is one of the accredited testing laboratories under the Food & Drug Administration (FDA) Accreditation Scheme for Conformity Assessment (ASCA) Program for medical devices safety and performance testing. 

As a designated ASCA-accredited laboratory, TÜV SÜD’s North American branches are authorized to assist medical device manufacturers with premarket testing. TÜV SÜD offers ASCA-accredited laboratory testing of medical devices at five branch locations: Minnesota, Massachusetts, California, Florida, and Canada.

Choose TÜV SÜD as your ASCA-accredited laboratory

TÜV SÜD offers a complete range of testing, certification and auditing services to manufacturers of medical devices. Represented in over 1,000 locations worldwide, TÜV SÜD has an unsurpassed track record of meeting the expectations of our client companies.

Interest in partnership with us? Contact us, and a member of our team will assist you.

EXPLORE

Understanding the FDA ASCA Pilot Program
Infographics

Understanding the FDA ASCA Pilot Program

Learn how the ASCA Pilot Program makes premarket testing of IVD products and medical devices more consistent and efficient

Learn More

VIEW ALL RESOURCES

Next Steps

Site Selector