For 2021, CDRH plans full ASCA pilot implementation

A pilot conformity assessment program will be ready for full launch in 2021, according to a report by the US Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH).
 
The report reviews the agency’s activities over the past year that supported full implementation of the Accreditation Scheme for Conformity Assessment (ASCA). Chief among these was the September 2020 publication of three final guidance documents that form the framework for the voluntary program. (RELATED: FDA finalizes ASCA pilot guidance as it gears up for launch, Regulatory Focus 24 September 2020; FDA discusses standards accreditation pilot ahead of launch, Regulatory Focus 5 February 2020).\
 
The pilot implementation plan was launched following the publication of the trio of guidances. “At that time, ASCA staff immediately began to engage with accreditation bodies and testing laboratories to describe the ASCA Pilot and roles and responsibilities,” according to the report. A group of accreditation bodies who indicated interest and completed applications were included in an initial list of ASCA-recognized bodies.
 
Testing laboratories are now following suit; interested laboratories who submit their applications by 9 February 2021 may be included on an initial list scheduled to go live on 12 April 2021.
 
Other steps taken in 2021 include the development of a quality management framework that makes use of CDRH’s ISO 9001:2015 Certified Quality Management System processes and tools. For the pilot, the framework was extended to include ASCA-specific procedures, instructions, forms and templates.
 
Outreach efforts accompanied the organizational and technical work. A November 2020 public webinar reviewed the guidance and went over the launch details; the ASCA team also held two question and answer sessions for laboratories who were interested in participating in the pilot.
 
From an administrative perspective, the ASCA web page has gotten a refresh and an upgrade, administrative workflows have been developed and streamlined “to drive efficient implementation and management of the ASCA pilot program, and FDA hit its hiring targets for the program, according to the report.
 
“In 2021, the ASCA Pilot staff are committed to advancing the full operationalization of the ASCA Pilot,” with a goal of bringing more qualified accreditation bodies and testing laboratories into the pilot, while encouraging sponsors to use the ASCA device submission pathway for marketing authorization applications.
 
More stakeholder engagement and outreach will be one strategy to achieving these goals, with a two-part “Industry Basics” program planned for 2021 to go over the nuts and bolts of ASCA pilot participation. The ASCA pilot will also be a topic at FDA’s May 2021 REdi conference, and the website will be updated regularly. Finally, FDA staff plan to hold regular individual meetings with a host of stakeholders.
 
Within CDRH, work is being done to make sure that document management systems recognize and appropriately route premarket submissions that contain conformity declarations from ASCA-accredited laboratories. New electronic templates have been prepared and will soon be rolled out, according to CDRH. Training for CDRH staff will accompany the workflow adjustments.
 
As the pilot program gets off its feet, FDA staff will track program results and keep an eye on how performance stacks up to the quality objectives set out for the ASCA pilot. As needed, FDA plans for “timely adjustments” to meet stakeholder needs. Through continuous improvement processes, procedures and templates will be updated as needed.
 
The overall goals of the ASCA pilot program are to bolster confidence in the processes used for medical device testing, as well as to inject more consistency and predictability into the premarket review portion of medical device authorization. In addition, FDA resources and regulatory efficiency should be enhanced by implementation of the pilot, which also meets agency goals of supporting international harmonization. “The FDA believes the experience gained in the ASCA Pilot could broadly inform international harmonization efforts such as standards’ use across jurisdictions,” wrote FDA in the background portion of the report.
 
ASCA Pilot report