The FDA released a follow-up statement to their “Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health” release that was unveiled in April 2018. The focus was expanding on post-market surveillance for medical devices. In this plan, the main objectives were to promote and improve public safety and detect safety risks earlier while keeping all those involved, including physicians, informed.
The plan specifically focuses on these five points:
- Establish a robust medical device patient safety net in the United States
- Explore regulatory options to streamline and modernize timely implementation of post-market mitigations
- Spur innovation towards safer medical devices
- Advance medical device cybersecurity
- Integrate the Center for Devices and Radiological Health’s (CDRH’s) premarket and post-market offices and activities to advance the use of a TPLC approach to device safety
Since this release, the FDA noted that they will update their plan with hopes of their new goal of ensuring that the FDA is “consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices” is met. A few approaches that the FDA will undertake to achieve this goal would be the focus of new technologies and new tools. The FDA noted that while their current post-market system in place helps achieve some of the objectives, the system places a great deal of burden on the user as this system is largely dependent on user complaints and problems and acts more as a passive systems rather than an active one. The FDA is aiming largely on collecting real-world evidence (RWE) in hopes to improve their National Evaluation System for health Technology (NEST). Recently, the FDA commented that the need for multiple stakeholders to come together to help establish and create new resources and tools for the data to be used would allow for better decision-making and safety assessment. By improving NEST, more relevant and quicker safety issues would be identified, which would not only protect and inform patients and physicians in their decision-making, but may help improve medical devices with new and improved innovations and/or design. This idea has already been improved upon and collaboration with industry has allowed the establishment of the Medical Device User Fee Agreements (MDUFA IV) which grants industry stakeholders and the FDA to work together while being more transparent in the overall pre-market approval (PMA) and 510k process. The MDUFA IV allows industry to pay user fees and in return, the Center for Devices and Radiological Health (CDRH) which is the branch that is responsible for the PMA of all medical devices as well as safety of these devices, agrees to increase center resources and to make reviews more timely, predictable, and transparent to Sponsors. The FDA also announced they hope to improve their Coordinated Registry Networks (CRN). These combine different real-world data sources to general clinical evidence used by patients. The FDA specifically stated their focus with these will be on women’s health and device therapies unique to women. Along with the development and updates to new systems and tools, collaboration between all parties involved is needed for further structuring and enhancement of post-market safety.
Even with the extensive pre-market clinical trials, benefits and risks of a device may not be known until well after the device reaches the market for the public. By improving upon the systems that are already in use, safety and adverse events, resulting from a medical device can be decreased or maybe even eliminated. The focus on post-market surveillance by the FDA can suggest many different things depending on the mindset. This focus can propose more trials or post-market registries for industry Sponsors to conduct which can drive up costs of the device to the consumers and the need for Contract Research Organization (CRO) expertise to help assist with those trials. This increase in cost can effect insurance reimbursement and insurance coverage costs. This focus can result in more FDA audits which put more time burden on those sites and institutions that are conducting those trials. The overall reach that this focus on post-market surveillance on medical devices can be calculated into dollars spent and time given; however, the impact that it may have on patients and safety cannot.
What do you think these new initiatives on post-market surveillance mean to Industry Sponsors? Do you think it’s the FDA or the Sponsors responsibility to ensure medical devices are safe after pre-market approval?