ASCA-Accredited Testing Laboratories

Update: September 18, 2025

The FDA has updated the “ASCA-Accredited Testing Laboratories” database to note the withdrawal of ASCA Accreditation for certain laboratories. These laboratories are listed as having an “FDA Initiated Withdrawal” status in the ASCA-accredited Testing Laboratory database. ASCA Summary Test Reports from laboratories with an “FDA Initiated Withdrawal” status will no longer be accepted.

During audits of ASCA-accredited testing laboratories, the FDA determined that the labs did not meet the requirements outlined in Section 514(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and related ASCA Program guidance(s). In some cases, the FDA identified concerns about the integrity of the data the labs submitted in premarket submissions. These findings raised serious questions about the ability of certain laboratories to fulfill their role in the FDA’s ASCA Program.

The FDA remains committed to maintaining the integrity of the ASCA Program and will continue to update the list of ASCA-accredited testing laboratories, as necessary. 

Update: July 28, 2025

DSCA has fully recognized IEC 61326-2-6 Edition 4 (Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment). This standard is part of the family of standards under IEC 61010 and within the scope of the ASCA Basic Safety and Essential Performance standards-specific guidance. This new edition is the result of active collaboration between CDRH and industry and greatly expands the ability of IVD device manufacturers to take advantage of the ASCA Program.

Please visit the ASCA-Accredited Testing Laboratories page for the lists of ASCA-accredited testing laboratories and their respective scopes of accreditation.