AST Support of Docket No. FDA-2013-D-1358

Wednesday, February 19, 2014

The AST recently submitted a letter to the Food and Drug Administration regarding draft guidance for (510(k)) submissions for nucleic acid-based HLA test kits. The AST endorsed comments from the American Society for Histocompatibility and Immunogenetics (ASHI) regarding this FDA draft guidance for industry Docket.

View ASHI's comments here.
View the AST's letter here.