Longmont, Colo.-based Acertara Acoustic Laboratories, an independent ISO/IEC 17025:2017 accredited medical ultrasound acoustic measurement, testing, and calibration laboratory, and ISO 13485:2016 certified probe repair and new product development facility, announces that the U.S. FDA has granted Accreditation Scheme for Conformity Assessment (ASCA) accreditation to Acertara for ultrasound compliance testing that covers the following International standards: IEC/ISO60601-2-37 and IEC/ISO60601-2-5.
As stated on the FDA’s website, “The ASCA Pilot supports the FDA’s public health mission by providing increased confidence in testing results from ASCA-accredited testing laboratories. The ASCA Pilot:
- Potentially decreases the burden of individual premarket submissions when manufacturers rely on testing completed by ASCA-accredited testing laboratories
- Incorporates existing international conformity assessment standards and practices, where practical
- Was created using input from experts across the medical device manufacturing and standards conformity assessment communities.
The FDA adds that “the voluntary ASCA Pilot is intended to enhance product reviewers’ and device manufacturers’ confidence in medical device testing, which should decrease the need for the FDA to request additional information regarding testing methodologies when a premarket submission includes declarations of conformity to an FDA-recognized consensus standard eligible for inclusion in the ASCA Pilot.”
Acertara is the only independent ultrasound testing facility in the world that has been granted this accreditation, company officials say. Plus, it’s now part of Acertara’s IEC/ISO 17025:2017 accredited services and is listed on the FDA ASCA website.
Commenting on this milestone, Levi Moore, Acertara’s president and COO, says, “We’re excited to receive the recognition from the FDA that extends our years of successful acoustic testing in support of ultrasound submissions to drive faster 510(k) reviews for our OEM customers. The whole ultrasound community has been working hard to develop new technologies that help patients—now those essential technologies can help patients sooner.”