501k Posts

Is the FDA Keeping the U.S. from Innovation?

This past January, the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) announced its plan of action for implementation of its 510(k) and science recommendations. Under section 510(k) of the Act, announced in August 2010, a person who intends to introduce a device into commercial distribution is required to submit a premarket notification, or 510(k), to FDA at least 90 days before commercial distribution is to begin.  While safety is at the core of this regulation, is it also limiting the possibilities for innovation and delivering products to market? (more…)