Medical Innovation Exchange

FDA to Host Virtual Workshop on ASCA Program Expansion



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.

Related Articles

  • “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together” outlines how FDA’s medical product centers plan to address regulation of AI used in medical products and their development.

  • Vladimir A. Makatsaria

    Vladimir A. Makatsaria, who most recently served as Company Group Chairman at Johnson & Johnson MedTech, leading its global Ethicon surgery business, has been appointed CEO of global medical technology company LivaNova. Former CEO Bill Kozy will serve a Board…

  • RQM plus logo

    Jordi labs and its team of Ph.D. analytical chemists developed a proprietary, multi-detector approach to ensure that all extractables are accurately characterized to comply with global materials testing regulatory requirements.

  • NIST logo

    The National Institute of Standards and Technology (NIST) is seeking input from industry to support its response to President Biden’s Executive Order on AI. Comments, which are due February 2, 2024, will help NIST develop guidelines for evaluation and red-teaming,…


Original post:

Post publish date:


Leave a Comment

Your email address will not be published. Required fields are marked *

Leave the field below empty!