The US Food and Drug Administration (FDA) has unveiled new efforts to improve and modernize its approach to medical device safety and innovation.
The new plan will focus on five key areas including the establishment of a robust medical device patient safety net in the country; to explore regulatory options to streamline and modernize timely implementation of postmarket mitigations; to encourage innovation towards safer medical devices,
The regulator also seeks to advance medical device cybersecurity and to integrate FDA’s Center for Devices and Radiological Health’s (CDRH) premarket and postmarket offices and activities to advance the use of Total Product Life Cycle (TPLC) approach to device safety.
CDRH will implement an integrated approach towards device safety throughout the TPLC by pursuing reorganization that integrate its premarket and postmarket offices across functions and allows expert to implement their knowledge of pre- and postmarket information to optimize decision-making.
All medical devices have their benefits and risks. Some of these risks can be better understood once the device is widely distributed and used under real-world conditions.
The FDA’s aim is to ensure that not only these devices meet the gold standard for getting into market, but also they should continue to meet this standard, as the regulator gets more data about the devices and to learn more about the benefit-risk profile.
The FDA stated that as it moves towards the TPLC structure, it is also exploring several new regulatory options to streamline timely implementation of postmarket mitigations as part of the plan.
The agency said that safe use of a device may require more information than the labelling provided to physicians. To deliver reasonable assurance of safety and effectiveness for certain complex technologies, the FDA may need to provide additional training or user education.
To do this effectively, the agency first may have to issue an umbrella regulation to identify such devices and mandate such requirements.
In the coming months, the FDA is planning to look at how it can focus on regulatory science activities on safety innovation, with the aim of developing scientific toolkits to be used premarket, so that developers can be better assured that their devices meet its safety standards.
The FDA also stated that it will be supporting developers pursuing safer devices, by exploring new ways to permit more streamlined pathways for comparative safety claims as a way to increase competition for improving features related to device’s safety profile.
Based on these lines, the FDA recently issued new draft guidance on a voluntary and more modern 510(k) pathway for moderate risk devices to demonstrate safety and effectiveness and the opportunity for device makers to show their products are safer than other technologies.
Another element of the action plan is that it recognizes safety and innovation should go hand in hand. Better technological advances should help in saving more lives and fewer adverse events.
The FDA wants to take new steps to encourage manufacturers to take the smallest changes to their devices, if their advances and adaptations could lead to reduction in risk to patients.