Currently, U.S. regulations are not on par with European and other international regulations for post-market surveillance. For the most common 510(k) devices, U.S. regulations do not require manufacturers to actively collect data on device performance. Instead, they tend to rely on complaints from the field and report only the most serious adverse events, even though a lack of complaints does not mean the device is performing well.

In regions outside of the United States, after a product gets to market and is in use, the expectation is that the medical device company will diligently, consistently and proactively follow up on its products and track:

• Who is using the device;
• How the device is performing months and even years after a procedure; and
• How similar medical devices are performing.

When a U.S. company tries to sell its product outside of the United States, the firm often finds itself unprepared and ill-equipped. This especially is true for companies with no experience dealing with international medical device regulations. Their assumption is that since it was cleared through the FDA, it should be a fairly straightforward process getting it to market in Europe or Asia. But without extensive post-market data, this couldn’t be further from the truth.

This mindset with U.S. companies and within the FDA gradually is changing. In fact, once the present 510(k) issues are sorted out in the United States, it’s very likely that the FDA will start scrutinizing post-market surveillance as well. The FDA already has started putting the framework together for new post-market surveillance requirements, which means that medical device companies should expect to soon feel the pressure to gather better information about their device’s total product life cycle and to implement more robust risk management and change control procedures.