May 15, 2014
FDA Targets Medical Device Companies

Since 2008, the U.S. Food and Drug Administration has increased its presence and tightened its control over medical device companies, and this trend is expected to continue through at least 2016.

Earlier this month, FDA released its 2012 medical device enforcement data, which evidenced:
• A significant increase in the number of inspections.
• A significant increase in the number of quality system warning letters issued.
• A significant increase in foreign facility increase and disproportionate increase in quality system warning letters issued to foreign firms.

To read the full alert, click here