Unfortunately, the FDA cannot always know the full extent of the benefits and risks of a device before it reaches the market. Even reasonably-sized premarket trials cannot be expected to reveal everything that could eventually become known about a novel medical device once it’s more widely distributed and used under real-world conditions, in broader patient populations, and by a broader range of clinicians.

Access to robust and timely data, including more extensive and informative post-market data and real-world evidence, is central to empowering the FDA to identify, communicate and act on new or increased medical device safety concerns. Such data serves as the foundation of our commitment to improving our nation’s post-market medical device surveillance. It’s one of the core pillars of our safety plan.


Investing in New Tools, Policies and Resources to Enhance Post-Market Safety

The goal that we’re establishing today – ensuring that the FDA is consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices – is an important milestone. It’s a culmination of steps that the agency has taken in recent years to strengthen and implement new post-market monitoring tools to adequately assess device performance and patient safety in real-time. Indeed, in many cases, we already have been the first to act on or identify and act on safety signals.

But, as we continue to look to the future, we aspire to build on the foundation that we’ve laid in recent years to become “consistently” first. We’re evolving beyond our current post-market surveillance system -- which is largely passive and relies on device users to report problems to us, sometimes resulting in underreporting. We’re moving to an active surveillance system that relies on real-world evidence and timely receipt of robust safety information. We have long recognized the systemic weaknesses of the passive system – a challenge faced by other countries – and we prioritized this area for regulatory reform efforts.

In 2012, FDA announced a vision for the medical device program that reflected the importance of safety, by looking to establish a “U.S. post-market surveillance that quickly identifies poorly performing devices, accurately characterizes real-world performance, and facilitates device approval or clearances.”

Soon thereafter, we issued a strategy for establishing a national medical device post-market surveillance system that employs active surveillance. Active medical device surveillance will better protect patients by continuously generating, accessing, and evaluating large data sets on device performance and clinical outcomes associated with device use in routine clinical practice. It also improves the FDA’s ability to link adverse events with specific devices, so we can act quickly with manufacturers and healthcare providers to make timelier, evidence-based decisions to mitigate device problems and keep patients safe.

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