A new Q&A sets the stage for how the US Food and Drug Administration's (FDA) Accreditation Scheme for Conformity Assessment (ASCA) will be piloted via the Standards and Conformity Assessment Program in FDA’s Center for Devices and Radiological Health (CDRH).
The ASCA pilot program is intended to “minimize the need to submit complete tests reports and reduce the number of additional information requests,” FDA said
. Greater consistency in these reports and predictability in the review process will come as part of the pilot “by enhancing FDA's confidence in the test labs' competence, and thereby in the test methods and results,” the agency wrote
in a separate page on the Standards and Conformity Assessment Program.
Enhanced use of consensus standards became a priority at CDRH following the enactment of the 21st Century Cures Act of 2017
and the FDA Reauthorization Act of 2017
. FDA final and draft guidance were issued
in September to clarify appropriate use of consensus standards as well as the recognition and withdrawal processes. The associated commitment
under the latest reauthorization of the Medical Device User Fee Amendments (MDUFA IV) involves setting up a program to serve as an accrediting mechanism for testing laboratories from which to accept declarations of conformity to recognized consensus standards as part of premarket reviews.
The work around the Standards and Conformity Assessment program coincides with the push for global regulatory harmonization. CDRH has encouraged demonstrating conformity to relevant standards in device submissions to help minimize duplicate work for compliance with premarket requirements and create efficiencies in review processes. The center previously vowed to advance the use of consensus standards globally as chair for the standards working group within the International Medical Device Regulators Forum.
to issue draft guidance before the end of this fiscal year based on the input it has been gathering
from stakeholders since last year, followed by the launch of the ASCA pilot program set to take place by 30 September 2020. The draft guidance will lay out criteria for pilot program participation and logistical details for operationalizing the pilot, according to the Q&A.
The scheme to be piloted is based on the ISO/IEC 17025 international consensus standards, which specifies the general requirements for the competence of testing and calibration laboratories.
“ASCA builds on the foundation that this important international consensus standard [ISO/IEC 17025] provides to identify program requirements for the testing laboratories who wish to become accredited,” the agency argued in a white paper
issued to guide discussions during a workshop
held in May to obtain feedback on the program’s framework, procedures and requirements.
The appropriate FDA-recognized consensus standards for inclusion in the ASCA pilot program will be announced “at a future date,” according to the new Q&A page. Yet an FDA analysis of potential fits resulted in the decision to use the IEC 60601 and ISO 10993 families for specific standards, according to the white paper. These include ISO 10993-5, -10, -11 and -4. FDA issued
a notice earlier this month to withdraw and replace several consensus standards with newer versions, including ISO 10993-11, as modifications to its list of recognized standards.
The pilot program will satisfy a MDUFA IV commitment to include “a minimum of five appropriate FDA-recognized consensus standards, at least one of which will be device-specific,” according to the Q&A. Expansion on the selected standards to be piloted will depend on “several factors.”
The ASCA program “will sunset 1 October 2022,” as required by law, FDA added. “However, if the pilot establishes the utility of the program, it may become permanent. We would expect to add more standards if and when the ASCA pilot program becomes permanent.”