Device makers give FDA an earful

Share this content:
Current Food and Drug Administration practices for approving new medical devices are ambiguous and slow, industry officials told the government last week. Manufacturers are often not aware of possible hurdles, they insisted. Moreover, delays can slow innovation and undermine a manufacturer's ability to remain viable, they added. An FDA spokesman acknowledged that regulatory guidance needs to be predictable, and that the government is taking steps to reduce unnecessary delays.

Next Article in Products