FDA to Host Virtual Workshop on ASCA Program Expansion

By MedTech Intelligence Staff
April 3, 2024


• Categories: 04-Product Design & Development, 05-Quality/Regulatory, Manufacturing, Medical Devices, Product Design, RC - Medtech Regulatory Resource Center

The FDA has announced a virtual public workshop on April 17 from 11:00am – 1:00pm ET to discuss approaches to expand the Accreditation Scheme for Conformity Assessment (ASCA) program. The ASCA program is designed to streamline conformity assessment aspects of medical device review. Currently, ASCA-eligible standards include standards and test methods from the basic safety and essential performance and biocompatibility series. The FDA is requesting stakeholders share their perspectives and priorities regarding potential expansion of the program.

The agenda for the workshop, which will be led by senior policy advisor Eric Franca, Ph.D., includes:

• Aspects of how the current set of ASCA standards worked well or could have worked better during the pilot phase
• Approaches to consider for ASCA expansion, e.g., options such as leveraging existing conformity assessment schemes, adding new standards or test methods
• New technical areas appropriate to consider adding to the ASCA program
• Question and Answer

Stakeholders who like to attend can register here.