Explore regulatory options to streamline and modernize timely implementation of postmarket mitigations;
Spur innovation towards safer medical devices;
Advance medical device cybersecurity; and
Integrate CDRH’s premarket and postmarket offices and activities to advance the use of a Total Product Life Cycle (TPLC) approach to device safety.
I’d like to highlight some of the particularly novel areas of this plan – some of which use our existing tools in new ways and some of which identify areas in which we may need additional authority.
To start, CDRH is implementing a more integrated approach to device safety throughout the TPLC by pursuing a reorganization that integrates CDRH’s premarket and postmarket offices across functions, and allows our experts to leverage their knowledge of pre- and postmarket information to optimize decision-making. All medical devices have benefits and risks. And some of these risks are better understood once the device is more widely distributed and used under real-world conditions, in broader patient populations, and by a broader range of clinicians. Our aim is to ensure not only that devices meet the gold standard for getting to market, but also that they continue to meet this standard as we get more data about devices and learn more about their benefit-risk profile in real world clinical settings.

As we move to the TPLC structure, we are exploring various new regulatory options to streamline timely implementation of postmarket mitigations as part of the Action Plan. For instance, we know that safe use of a device may require more than information in the labeling provided to physicians. To deliver reasonable assurance of safety and effectiveness for certain highly complex technologies, we may need to require additional training or user education. To do this efficiently under our existing authorities, we’ll consider issuing an umbrella regulation to identify these devices and mandate these requirements.

Furthermore, on a case-by-case basis, we may consider invoking restricted device authority to increase patient protection for our highest risk devices when such measures are needed. When the benefit-risk profile of a specific device requires us to increase our regulatory oversight, we’ll consider whether issuing an order specific to that device is the best way to impose requirements to protect patients from harm, while still permitting access to the device for those patients who may benefit from it.

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