Feb 12, 2020

A new report from the US Food and Drug Administration on its Accreditation Scheme for Conformity Assessment (ASCA) pilot program explains the agency’s progress thus far as well as ongoing implementation plans ahead of the program’s expected launch later in 2020.

The report lays out next steps FDA will undertake in order to formally establish the ASCA pilot this year. First proposed in 2017, the ASCA program is intended to improve consistency of FDA medical device premarket submissions by utilizing accredited testing laboratories to evaluate whether US market applicants’ declarations of conformity to voluntary consensus standards such as ISO 10933-4 for biological evaluation of devices and ANSI/AAMI 60601-1 for safety and performance of medical electrical devices. The report follows draft guidance FDA issued in September 2019.  

Next steps for ASCA pilot implementation

FDA intends to publish final guidance on the ASCA pilot by September 30, 2020, after which point the agency will implement several steps toward fully launching the program. These include:

  • Educational programs to attract participants in the ASCA pilot;
  • Establish training processes for accredited testing laboratories;
  • Evaluate applications from accreditation bodies and labs;
  • Train FDA Center for Devices and Radiological Health (CDRH) staff on reviewing ASCA pilot medical device premarket submissions;
  • Identify and implement tools for evaluation of performance and other program metrics.

Progress thus far

Besides publishing ASCA draft guidance in 2019, FDA has achieved other milestones in terms of getting the ASCA pilot up and running. These include meeting hiring targets to ensure adequate staffing to manage the program; boosting conformity assessment skills among ASCA staff members; and outreach initiatives to external stakeholders such as device manufacturers, testing laboratories and trade associations.

Related US FDA medical device regulatory resources from Emergo by UL:

  • US FDA 510(k) consulting for medical device companies
  • FDA QSR (21 CFR 820) consulting for medical device manufacturers
  • Whitepaper: Preparing a US FDA 510(k) submission