FDA Commissioner Scott Gottlieb releases statement regarding the safety of medical devices

By Catherine Sturman
The release of new medical devices has been embraced by the healthcare industry, but the tools have also introduced a number of risks which have yet to...

The release of new medical devices has been embraced by the healthcare industry, but the tools have also introduced a number of risks which have yet to be addressed.

Last year, the FDA approved a record number of novel devices in the US, reflecting an advancing pace of innovation. One such example is the first artificial pancreas and the first blood test to evaluate traumatic brain injury.

Whilst the FDA continues to play a key role in driving innovation and tackling the essential need for regulation, FDA Commissioner Scott Gottlieb has released a statement covering a wide range of areas.

“My colleagues in the FDA’s Center for Devices and Radiological Health (CDRH), led by Dr. Jeffrey Shuren, have been advancing new policies to drive innovation in medical product development by taking novel approaches to regulation, including the use of real world evidence to support iterative improvements in device performance and establishing a balanced framework for digital health devices that improves the lives of patients,” he said.

“Although medical devices provide great benefits to patients, they also present risks. And we are focusing equal attention on advancing new frameworks for identifying risks and protecting consumers.”

By prioritising its approach to medical device safety, the FDA continues to work closely with patients, providers, and device developers to improve new technologies which are entering the market.

The FDA has subsequently released the Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health, explaining how the organisation will further its programmes and processes and new technologies will provide capabilities which bring added assurances of safety.

The action plan will encompass five key areas:

  1. The establishment of a robust medical device patient safety net;
  2. Regulatory options to streamline and modernise timely implementation of post market; mitigations;
  3. Spur innovation towards safer medical devices;
  4. Advance medical device cybersecurity;
  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.

“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,” Gottlieb added.

By providing additional training and education, new regulations will be put in place. To spur innovation, the FDA’s Breakthrough Device Programme will address unmet medical needs to facilitate patient access and improve patient safety.

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 “In the coming months, we’ll also look at how we can focus more of our regulatory science activities on safety innovation, with the aim towards developing scientific toolkits to be used premarket, so that developers can better assure that their devices are meeting our standards for safety,” says Gottlieb.

“To help support developers who are pursuing safer devices, we’re exploring ways to permit more streamlined pathways for comparative safety claims as a way to spur competition on improving features related to a device’s safety profile.

We have issued new draft guidance on a voluntary, more modern 510(k) pathway for moderate risk devices to more efficiently demonstrate safety and effectiveness and the opportunity for device makers to demonstrate their products are safer than other technologies on the market.”

Continuing its work with the National Evaluation System for health Technology (NEST), the FDA will facilitate the ongoing detection of potential safety risks, and The Action Plan illustrates how the organisation will support the development of NEST.

Furthermore, as part of the Action Plan, the FDA is establishing the Women’s Health Technologies Strategically Coordinated Registry Network (CRN) to provide more complete evidence in clinical areas which are unique to women.

“Finally, I want to highlight another important issue we’re staying on top of related to device safety:  cybersecurity. Like computers and the networks they operate in, medical devices can be vulnerable to security breaches. Exploitation of device vulnerabilities could threaten the health and safety of patients,” noted Gottlieb.

“We’ve already taken several steps to promote a multi-stakeholder, multi-faceted approach of vigilance, responsiveness, recovery, and resilience that applies throughout the life cycle of relevant devices.

As part of the Action Plan, we’re seeking additional authorities and funding for Congress to consider, which would build on our work to date and further minimise medical device cybersecurity vulnerabilities and exploits.

We also intend to seek the authority and funding to develop a CyberMed Safety (Expert) Analysis Board, a public-private partnership that would complement existing device vulnerability coordination and response mechanisms and serve as a resource for device makers and the agency.

Medical device safety is a key priority for the FDA. We’re committed to protecting American patients by minimising avoidable risks and advancing device technologies that are delivering growing benefits.”


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