Changes to the 510(k) process

In light of recent developments, such as allegations of improper 510(k) clearances instigated by FDA officials, and the removal of Dr. Schultz as head of CDRH, many people expected the FDA to change the 510(k) process drastically. But this may be further off than you think, according to Dr. Jeffrey Shuren acting CDRH director, in an article in the Startribune.