The Food and Drug Administration has been the target of criticism from Republicans and the medical device industry alike, arguing that increased medical device approval times are pushing innovation abroad.
After holding several hearings examining the FDA's approval process, House Energy and Commerce Chairman Fred Upton, R-Mich., last Friday unveiled a package of legislation that Republicans say will "improve the predictability, consistency, and transparency of FDA's medical device review and approval process."
The legislation would require FDA reviewers to provide "scientific or regulatory rationale for major decisions," and reaffirms that FDA should follow "least burdensome" practices to approve devices. You can read more about the bills here.
Do you think these proposals will be useful to getting new treatments to market? Or will these changes put patients in danger with unchecked devices?