On 17 December 2019, TIC Council submitted comment to the FDA regarding the FDA ASCA Medical Device pilot program guidance. The draft guidance was released in September of 2019 and the FDA has held webinars and a Q&A session to address stakeholder questions. TIC Council Americas met with the FDA on 20 November 2019 to discuss further and from these interactions has developed our TIC Council public comments.
TIC Council's comments on this important issue can be found here. TICC continues to support the work of the FDA and looks forward to continued engagement on this issue. For relevant information on TICC and TICC positions, please see the TICC publications at www.tic-council.org/publications