Acertara Acoustic Laboratories Receives FDA Accreditation for the Agency’s Pivotal Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
Acertara Acoustic Laboratories Receives FDA Accreditation for the Agency’s Piviotal Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
LONGMONT, Colorado– Acertara Acoustic Laboratories, an independent ISO/IEC 17025:2017 accredited medical ultrasound acoustic measurement, testing, and calibration laboratory, and ISO13485:2016 certified probe repair and new product development facility, announces that the United States Food and Drug Administration (FDA) has granted 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 program, “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: (1) Potentially decreases the burden of individual premarket submissions when manufacturers rely on testing completed by ASCA-accredited testing laboratories, (2) incorporates existing international conformity assessment standards and practices where practical, and (3) was created using input from experts across the medical device manufacturing and standards conformity assessment communities. 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. Ultimately, the ASCA Pilot is intended to help the FDA ensure patients have timely and continued access to safe, effective, and high-quality medical devices.” Acertara is the only independent ultrasound testing facility in the world that has been granted this accreditation and it is now part of our IEC/ISO17025:2017 accredited services and is listed on the FDA ASCA website. Commenting on this significant milestone Levi Moore, Acertara’s President and COO said, “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.”
Questions and Comments about the FDA ASCA program and Acertara accreditation should be directed to Ms. Callie Moore, M.Sc., RAC, Senior Director of Quality and Regulatory Affairs for Acertara – [email protected]. 303. 834.8413
About Acertara:
Acertara Acoustic Laboratories, 1950 Lefthand Creek Lane, Longmont, Colorado 80501 is an ISO/IEC 17025:2017 accredited acoustic measurement laboratory and ISO13485:2016 ultrasound probe repair facility providing acoustic power testing services to ultrasound OEMs and regulatory bodies around the world, new product development, and advanced probe repair. Additional information about Acertara can be found on its Website www.acertaralabs.com