As numerous trade journals have reported over several months, the VALID ACT (FDA control of LDT diagnostic tests) has been rising and falling regarding its odds of becoming legislation.
In a new twist, Scott Gottlieb and Mark McClellan, both former heads of the FDA, strongly encourage Congress to pass the VALID ACT and as soon as possible. (McClellan is a former head of both FDA and CMS).
Find it here:
Among others, AdvaMed is also urging Congress to push ahead with VALID (here).
The Regulatory Affairs Professionals Society, RAPS, hosts a two day course on the new European IVD regulations, October 18-19 in Amsterdam, full agenda here.