Medical Device Manufacturers Seek Quick Approval Overseas

Feb 11, 2011   

Recently, medical device manufacturers have been shifting their operations overseas in an effort to speed up the approval process. More relaxed regulatory oversight abroad has led some of these companies to make the move to Europe, Asia, and Latin America. Rather than deal with the stringent approval process for medical devices in the United States, these companies are looking for a less costly and time consuming way to bring new products to market.

While the FDA is responsible for administering the regulatory scheme surrounding medical devices in the United States, critics argue that the Agency has gone too far by scrutinizing new products and creating a lengthy, complex process. Currently, the two main pathways for medical devices to enter the market are through premarket approval (PMA) and the 510(k) process. While the premarket approval process is a more complicated and time-consuming pathway, both require a device manufacturer to demonstrate that the product is safe and effective for its intended use. The advantage that device manufacturers may find abroad is a more relaxed approval process through which a demonstration of a devices safety alone may secure the approval necessary to bring a product to market. Unlike the regulatory requirements in the United States, showing that a device is effective for its intended use is often not required abroad.

However, this perceived advantage may be short-lived. The FDA has begun to review the current pathways for medical devices. As we previously reported, the FDA recently proposed several changes to the 510(k) process. These changes are primarily aimed as increasing the efficiency of the device approval process and reflect some recognition that reform is necessary to ensure that the United States remains at the forefront of medical device innovation. As we previously reported, the FDA has also proposed its Innovation Initiative, a plan targeted at streamlining the medical device approval process thereby reducing costs associated with research and development of new devices. While no official changes to either the PMA or 510(k) process have come into effect, the FDA expects to implement some of these measures later this year.

The FDAs review of medical devices through the 510(k) or PMA process is complex. Fuerst Ittleman has extensive experience successfully navigating medical devices through FDA review. For more information on FDAs review of medical devices, please contact us at