On April 17, 2018, FDA announced its plan to launch the Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health (Action Plan), which aims to support and advance innovation in medical devices while also assuring the safety of the devices throughout their Total Product Life Cycle (TPLC). To that end, FDA intends to focus on the following five major areas:
- Establish a robust medical device patient safety net in the United States by improving the quality and reliability of real-world evidence that manufacturers assess to support the safety and effectiveness of their products.
- Explore regulatory options to streamline and modernize timely implementation of post-market mitigations.
- Spur innovation toward safer medical devices.
- Advance medical device cybersecurity.
- Integrate the Center for Devices and Radiological Health’s (CDRH) pre-market and post-market offices and activities to advance the use of a TPLC approach to device safety.
The Action Plan builds upon existing programs that the Agency employs in the regulatory oversight of medical devices, including the Unique Device Identification System, use of real world evidence, and the National Evaluation System for Health Technology (NEST). For example, the Action Plan discusses FDA’s plans to seek additional funding and capabilities of NEST needed to realize its goal of establishing a robust medical device patient safety net.
FDA intends to streamline its process for requesting device manufacturers to implement post-market mitigations (such as, labeling, user training, and device features) by exploring the possibility of issuing umbrella regulations to identify devices that might require additional training or user education. Currently, FDA’s process for implementing mitigations through special controls requires rulemaking, which the Agency identifies as challenging and time consuming.
FDA’s Action Plan describes a multi-factor approach to spurring innovation toward safer medical devices. For example, the Agency plans to create opportunities for increased interactions between FDA staff and the device developers during the development, evaluation, and pre-market review phases of their products or by providing more streamlined pathways for comparative safety claims. Additionally, FDA released a draft guidance document, Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence Through Performance Criteria, on April 12, 2018, which establishes a voluntary, 510(k) pathway for demonstrating the safety and effectiveness for certain moderate-risk devices. In this guidance, FDA proposes to expand the 510(k) pathway to allow manufacturers of well-understood moderate-risk devices to use performance criteria to demonstrate substantial equivalence of their device to legally marketed predicate devices. Specifically under this pathway, if a new device meets or exceeds the level of performance relevant to the safety and effectiveness of a legally marketed device, then FDA could find that the new device is as safe and effective as the legally marketed device. Thus, rather than submitting data from direct comparison testing between the new device and the legally marketed predicate device, the manufacturer may establish substantial equivalence by demonstrating conformance to performance criteria established in FDA guidance, FDA-recognized consensus standards, and/or special controls.
In an effort to improve cybersecurity for medical devices, FDA will, among other things, consider seeking new pre-market authorities, such as requiring device manufacturers to build capability to update device security into a product’s design. Further, FDA intends to explore the development of a CyberMed Safety (Expert) Analysis Board (CYMSAB), a public-private partnership, which would assess cybersecurity vulnerabilities and evaluate patient safety risks at FDA or the manufacturer’s request.
Finally, FDA reiterates its previously announced plan to reorganize and streamline the structure of CDRH into one large office responsible for pre-market review, post-market surveillance, manufacturing and device quality, and enforcement actions relating to a device. The Agency believes this approach will enable its employees to have a more universal regulatory view of a device throughout its TPLC rather than at a specific stage of the product’s life cycle.
While it is difficult to gauge the full impact this Action Plan, it is clear that the medical device industry should plan for changes as the Agency further evolves its oversight of medical devices. Although device manufacturers stand to benefit from certain aspects of the Action Plan, particularly with respect to the abbreviated 510(k) pathway, other aspects may result in increased burdens and regulatory obligations. FDA is accepting comments on the Action Plan, which may be submitted through the public docket (FDA-2018-N-1315) at www.regulations.gov.