Congressman Erik Paulsen said Thursday that the FDA’s pre-market review processes lack “consistency, predictability, and transparency,” which is making it difficult for firms to bring their products to market in the United States. The United States is at risk of losing medical device companies to other countries because of the U.S. Food and Drug Administration (FDA) processes to approve devices, according to Congressman Erik Paulsen. Paulsen spoke Thursday at a House Committee on Oversight and Government Reform hearing called “Pathway to FDA Medical Device Approval: Is there a Better Way?”
