The ANSI National Accreditation Board (ANAB), a wholly owned subsidiary of the American National Standards Institute (ANSI), has been recognized by the U.S. Food and Drug Administration (FDA) as an accreditation body for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot. The FDA recognition allows ANAB to accredit testing laboratories to perform premarket testing for medical device companies.
The voluntary ASCA pilot is intended to increase consistency and predictability in the FDA’s approach to assessing conformance with FDA-recognized consensus standards and test methods for medical devices. The pilot is also intended to enhance product reviewers’ and device manufacturers’ confidence in medical device testing. This, in turn, should decrease the need for the FDA to request additional information about testing methodologies when a premarket submission includes declarations of conformity to an FDA-recognized consensus standard eligible for inclusion in the ASCA pilot.
“ANAB’s participation in the ASCA pilot is consistent with our mission to provide accreditation processes that build confidence and provide value for stakeholders,” said Jason Stine, ANAB senior director of accreditation. “We look forward to supporting the FDA’s goal of helping ensure patients have timely access to safe, effective, and high-quality medical devices.”
The ASCA pilot relies on international conformity assessment standards and a set of FDA-identified ASCA program specifications. The program includes both cross-cutting and device-specific standards. Reflecting the comprehensiveness of the program, the FDA selected standards and tests from the biocompatibility series and the basic safety and essential performance series, all of which have public health significance and provide the means for establishing acceptance criteria. ANAB’s scope of ASCA pilot recognition includes the full array of ASCA pilot standards.
Participants in the pilot include accreditation bodies (such as ANAB), ISO/IEC 17025 testing laboratories, medical device manufacturers, and FDA staff.
Manufacturers fund the pilot program through the FDA’s Medical Device User Fee Amendments of 2017 User Fee program. There is no additional fee for manufacturers to participate in the pilot, nor does the FDA charge a fee for accreditation bodies or laboratories participating in the pilot.
Testing laboratories interested in gaining ASCA accreditation must first seek accreditation to ISO/IEC 17025:2017 and the relevant ASCA program specifications from an ASCA-recognized accreditation body. For information about ANAB accreditation under the ASCA pilot, contact Roger Muse, ANAB vice president of business development, at [email protected].
The ANSI National Accreditation Board (ANAB) is the largest multi-disciplinary ISO/IEC 17011 accreditation body in North America, with comprehensive signatory status across the multilateral recognition arrangements of the International Laboratory Accreditation Cooperation (ILAC) and International Accreditation Forum (IAF). The ANAB accreditation portfolio includes management systems certification bodies, calibration and testing labs, product certification bodies, personnel credentialing organizations, forensic test and calibration service providers, inspection bodies, police crime units, greenhouse gas validation and verification bodies, reference material producers, and proficiency test providers.
ANAB is a wholly owned subsidiary of the American National Standards Institute (ANSI), a private, not-for-profit organization dedicated to supporting the U.S. voluntary standards and conformity assessment systems and strengthening their impact, both domestically and internationally, including by administering procedures and criteria for accreditation of conformity assessment programs and encouraging organizations to prepare and submit such programs for accreditation.
The American National Standards Institute, Inc. (ANSI) is a private non-profit organization whose mission is to enhance both the global competitiveness U.S. business and the U.S. quality of life by promoting and facilitating voluntary consensus standards and conformity assessment systems, and safeguarding their integrity. Its membership is comprised of businesses, professional societies and trade associations, standards developers, government agencies, and consumer and labor organizations.
The Institute represents and serves the diverse interests of more than 270,000 companies and organizations and 30 million professionals worldwide. ANSI is the official U.S. representative to the International Organization for Standardization (ISO) and, via the U.S. National Committee, the International Electrotechnical Commission (IEC). For more information, visit www.ansi.org.