FDA Details Long-Awaited Standards Accreditation Pilot in New Draft Guidance

Regulatory NewsRegulatory News | 23 September 2019 |  By 

The US Food and Drug Administration (FDA) on Friday issued draft guidance outlining its much-anticipated voluntary conformity assessment pilot, known as the Accreditation Scheme for Conformity Assessment (ASCA).
The program is meant to increase "consistency, predictability and efficiency" during the premarket review of medical devices by creating a scheme for accrediting third party testing laboratories to eligible consensus standards. Device makers would then be able to use testing performed by those labs to support premarket submissions to FDA.
"These standards, given their contributions to regulatory science and practice, play an increasingly prominent role in ensuring that medical devices are safe and effective," said Captain Scott Colburn, director of the Standards and Conformity Assessment Program at the Center for Devices and Radiological Health (CDRH).
As part of the agency's negotiations with industry for reauthorizing the Medical Device User Fee Amendments (MDUFA), FDA agreed to establish a program for accrediting test labs that evaluate devices for conformity to FDA-recognized consensus standards.
While FDA currently recognizes a broad variety of standards developed by organizations such as the American National Standards Institute (ANSI), International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC), the agency has said the use of consensus standards in device submissions "has not been consistently applied by sponsors."
In 2017, FDA consulted with stakeholders on what standards should be included in the pilot and other issues such as whether test labs are accredited to existing laboratory standards or whether FDA itself should act as an accreditation body.
Pilot Program
In a 64-page draft guidance, FDA lays out the parameters of the ASCA pilot program, explains the roles of the various players including accreditation bodies, test labs, device makers and agency staff, details the two categories of device standards that will be included in the pilot, and sets out criteria for accreditation bodies and test labs to participate.
The draft guidance also explains how device makers can make use testing conducted through the pilot and how the agency will approach testing results obtained through the pilot that are included in premarket submissions.
FDA explains that it "does not intend to question the validity of test methods and outcomes from ASCA-accredited testing laboratories except as part of periodic audits, if the summary test report indicates an issue with the testing or device, or if FDA becomes aware of information materially bearing on the safety or effectiveness of the device."
For the pilot, FDA has selected consensus standards that fit within two categories, biological evaluation of medical devices and basic safety and essential performance of medical electrical equipment, medical electrical systems and laboratory medical equipment.
The specific standards within those categories include:
  • Biological Evaluation of Medical Devices:
    • ASTM F756: Standard Practice for Assessment of Hemolytic Properties of Materials
    • ISO 10993-4: Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood
    • ISO 10993-5: Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
    • ISO 10993-10: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
    • ISO 10993-11: Biological evaluation of medical devices – Part 11: Tests for systemic toxicity
    • USP<151>: Pyrogen Test
    • ISO 10993-12: Biological evaluation of medical devices – Part 12: Sample preparation and reference material
  • Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment:
    • ANSI/AAMI ES60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (along with the FDA-recognized collateral and particular standards in the 60601/80601 family)
    • IEC 61010-1: Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements (along with the FDA-recognized particular standards in the 61010 family)
FDA says it is looking for input on the draft guidance through 23 December 2019 any says it plans to launch the ASCA pilot by the end of FY2020.


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