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FDA releases action plan to enhance medical device safety

The FDA has announced that it is working towards new frameworks for enhancing medical device safety.

The agency’s latest action plan outlines the approaches it will take to advance its programmes and processes to ensure medical devices are safe.

Led by Dr Jeffrey Shuren, the FDA’s Center for Devices and Radiological Health (CDRH), is working on new policies that utilise real world evidence and is establishing a framework for digital health devices.

Five key areas are addressed within the action plan, including:

  1. Establish a robust medical device patient safety net in the US;
  2. Explore regulatory options to streamline and modernise timely implementation of post-market mitigations;
  3. Spur innovation towards safer medical devices;
  4. Advance medical device cybersecurity; and
  5. Integrate CDRH’s premarket and post-market offices and activities to advance the use of a Total Product Life Cycle (TPLC) approach to device safety.

The reorganisation of the CDRH’s premarket and post-market offices is intended to allow its experts to leverage their knowledge of pre and post-market information for medical devices.

Speaking about the decision, FDA commissioner Scott Gottlieb, said:

“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.”

Within the TPLC structure, the FDA is also exploring new regulatory options to streamline post-market mitigation. For instance, if a device requires more than information currently provided within the labelling, the FDA may need to establish additional training or user education through an umbrella regulation.

The FDA will also work on a case-by-case basis to increase patient protection from the highest risk devices. The FDA will consider the benefit-risk profile of a device, making it available to certain patients whilst restricting access to those it may be harmful to.

Within the coming months, the agency will look at developing scientific toolkits for medical device developers to use to ensure their products are meeting standards for safety. Last week the FDA issued new draft guidance to help streamline safety pathways for moderate risk devices.

The plan also references a need to establish data from technologies which address women’s health. The FDA has started building registries and is establishing the Women’s Health Technologies Strategically Coordinated Registry Network (CRN) to provide better evidence for clinical areas related to women’s health.

Lastly, the FDA is working towards increasing its understanding of cyber-security issues related to medical devices and is seeking additional authorities and funding for Congress to help minimise cyber-security risks. The FDA is also aiming to develop a CyberMed Safety (Expert) Analysis Board that would “complement existing device vulnerability coordination and response mechanisms and serve as a resource for device makers and the agency,” Gottlieb states.

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