How Labs Should Prepare for New Laboratory Developed Test Rules and What Comes Next

Now that the U.S. FDA has issued its long-awaited final rule on new oversight requirements for Laboratory Developed Tests (LDTs) how should medical labs look to respond in both the short- and long-term? During a recent conversation exploring the implications of the final rule and its impact on labs, Jeffrey Gibbs, Director at FDA law firm Hyman, Phelps & McNamara, discussed what labs should be doing now to prepare for these changes and whether or not new developments could put this initiative on hold in the coming months.
Jump to:
-Developments to watch before taking action (0:25)
-Should we start submissions now? (0:45)
-The ongoing debate (1:23)
-What could happen next? (1:52)
-Could VALID make a comeback? (2:10)
-Could the election change things? (2:35)
#ldt #medicallab #fda #laboratorymedicine #ivd