In April, the FDA released its “Medical Device Safety Action Plan,” a short to mid-term vision for increasing the safety of medical devices. In it, the FDA acknowledges that enhancements and changes in its approach to device safety are necessary to ensure that it is “vigilant” in keeping up with the developments in the complexity and number of medical devices.
Key to the FDA’s new approach is focusing on the “Total Product Life Cycle (TPLC)” of each type of medical device, so that safety issues are not left unaddressed following a device’s approval by the FDA. In this effort, the FDA will emphasize timely communication and resolution of new safety issues and help to advance innovations in technology that result in safer and more effective devices.
How will this impact physicians?
The Plan sets forth certain action items that the FDA will be addressing over the next few years. Each of these items could impact physicians who use medical devices in treating patients. Some of these matters (such as additional training for physicians) will likely require new regulations. Others may require only funds from Congress. Highlights include:
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The FDA is considering a new regulatory approach to issuing additional safety requirements for devices with newly-discovered or increased safety risks. Instead of working on a one-off basis with individual manufacturers to address safety concerns, the FDA would like to issue regulations to address new safety matters. These regulations (called “special controls”) could require manufacturers to conduct additional training for physicians who implant the devices.
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The FDA would like to facilitate the approval of devices that appear safer than devices that are currently on the market, so that government is less of a barrier to the entry of safer devices into the market.
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The FDA would like to focus on improving the safety of medical devices implanted in women, generally, as there have been many issues with these types of devices over the years.
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The FDA would like to expand its support for a public-private system called NEST (National Evaluation System for Health Technology), which is designed to monitor insurance claims, electronic health records and other data for early signs of device problems. The project will cost $250 million over 5 years, and device manufacturers are slated to contribute $30 million to the effort.
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The FDA would like to require cybersecurity features for electronic devices, such as pacemakers and defribrillators. In response to the growing awareness of the security risks of medical devices that connect to the Internet (and, therefore, become part of the “Internet of Things”), the FDA recognized the need for a long-term focus on pre-market and post-market actions to continually address cybersecurity threats. Expect a CyberMed Safety Analysis Board to be formed to not only evaluate cybersecurity risks of electronic devices, but serve as a “go-team” deployed into the “field” by the FDA to investigate suspected compromises to electronic device security.
More details on the Plan can be accessed here. Stay tuned to the Fox Rothschild Physician Law Blog for updates on how the FDA’s implementation of the Plan could impact physicians.
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