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Regulatory Focus™ > News Articles > 2020 > 2 > FDA Discusses Standards Accreditation Pilot Ahead of Launch

FDA Discusses Standards Accreditation Pilot Ahead of Launch

Posted 05 February 2020 | By Michael Mezher 

FDA Discusses Standards Accreditation Pilot Ahead of Launch

With a launch expected later this year, the US Food and Drug Administration (FDA) released a report Wednesday detailing its work towards establishing its Accreditation Scheme for Conformity Assessment (ASCA) pilot in 2019.
 
The report comes just months after FDA issued draft guidance outlining the much-anticipated scheme and detailing the standards that will be eligible during the pilot.
 
The pilot is one of FDA’s commitments under the latest reauthorization of the Medical Device User Fee Amendments (MDUFA IV) to create a scheme for accrediting third party testing laboratories with eligible consensus standards that device makers can rely on for premarket submissions.
 
FDA says its goals for the pilot are to increase confidence in device testing, improve the consistency and predictability of premarket reviews and support international harmonization.
 
“If the ASCA pilot goals are met, we would expect to see significant benefits,” FDA writes, noting that it predicts the pilot will lead to fewer internal consultations, test report reviews and requests for additional information from manufacturers.
 
Progress and Next Steps
 
In the report, FDA outlines the steps it has taken so far to build the ASCA pilot and the steps it plans to take ahead of the pilot’s launch, including staffing up for the program, conducting internal and external outreach, finalizing guidance and conducting staff training.
 
On staffing, FDA says it has met its hiring goals for the program from 2017 to 2019, with four new hires and that it plans to hire one additional employee for the program in 2020. The agency also says it has appointed a “detailee” to assist with internal training and has continued to rely on a consultant from the National Institute of Standards and Technology (NIST).
 
In 2019, FDA says it focused its internal outreach on enhancing conformity assessment skills and knowledge for its ASCA team and raising awareness among other staff ahead of the pilot’s launch. FDA says its ASCA team visited testing laboratories under the Center for Devices and Radiological Health (CDRH) Experiential Learning Program and the NIST Standards Boot Camp.
 
For non-ASCA staff, FDA says it held education sessions for staff within the Office of Product Evaluation and Quality (OPEQ) and the Office of Science and Engineering Laboratories (OSEL) to go over the ASCA draft guidance and solicit feedback.
 
As for external outreach, FDA says it held 10 roundtables with accreditation bodies and gave three presentations to testing laboratories, 15 presentations to device makers and 12 presentations to standards developing organizations.
 
FDA also says it has taken steps to ensure the ASCA pilot is ready for an “out of the gate start” once the guidance is finalized, including ensuring compliance with the Paperwork Reduction Act, upgrading the ASCA webpage and establishing internal processes and standard operating procedures (SOPs).
 
Going forward, FDA says its focus will be on finalizing and implementing the ASCA pilot guidance, which it says is anticipated by the end of September.
 
Once the guidance is finalized, FDA says it will take additional steps, including launching educational programs to promote participation in the pilot, review applications from interested accreditation bodies and testing laboratories and train CDRH review staff on how to handle ASCA pilot device submissions.
 
Report

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