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In 2018, the FDA achieved a new record of approving 106 new devices.
The FDA also outlined the latest steps in its plan to strengthen the 510(k) clearance program, including a new final guidance for moderate-risk devices to use a separate set of criteria in their demonstrations of substantial equivalence to already-marketed devices.
The FDA has finalized its new device guidance program: the Safer Technologies Program (STeP). It assess products that may not meet the high criteria for the Breakthrough Devices Program, but that would still offer significant benefits in safety compared to current devices or diagnostics. Other documents expected in 2019 include the final guidance on the 510(k) program.
International investigation links 1.7M injuries to medical devices, as FDA moves to reform its 510(k) process
The FDA plans to update the guidelines of its 510(k) clearance program, which allows manufacturers to compare their products against previously cleared predicate devices to demonstrate that they are just as safe and effective. More clarity from the FDA is expected in the coming weeks and the finalized guidelines are expected to be released in early 2019.
In an effort to improve its current post-market surveillance system, the FDA is moving to an active surveillance system building upon its unique device identification initiative. This initiative tags each device with a code that can be tracked across its distribution and use in patients, and is expected to advance the FDA’s efforts to leverage real-world data to support the development of more effective post-market surveillance tools.
The European Union’s new Medical Device Regulation and its requirements take full effect in May 2020. However, the majority of medical device companies surveyed do not have sufficient understanding of the EU MDR. In particular, there are concerns with clinical data collection and post-market surveillance and tracking.
In the latest round of tarriffs in the US-China trade war, nearly all U.S. medical devices exported to China are affected. Furthermore, China has also threatened to impose extra, unspecified, non-tariff barriers such as slower regulatory approvals and possible investigations into company operations within the country.
FDA plans to address cybersecurity threats to networked medical devices in its next update. In particular, the FDA will (1) use presubmission meetings with manufacturers to better address cybersecurity-related questions; (2) include cybersecurity as an element in its template used in 510(k) submissions; and (3) require cybersecurity documentation elements on its refuse-to-accept checklists.
The FDA is planning to expand its abbreviated 510(k) program to lessen the burden of demonstrating substantial equivalence. In draft guidance (PDF), the FDA set out how sponsors can win clearance for devices after showing they meet certain performance levels, rather than through direct comparisons with predicate products.
“By allowing a set of objective, transparent and well-validated performance metrics to serve as the benchmark for evaluating some new devices, this new pathway offers a more efficient and less burdensome option,” FDA commissioner Scott Gottlieb said.
In freeing sponsors from predicate testing, the FDA also thinks it can streamline the review process for its own staff, lessening the burden the task places on it and potentially shortening clearance times.
Banyan Biomarkers has received FDA’s first approval for a blood test for use in the detection of concussion. This blood test analyzes the levels of UCH-L1 and GFAP proteins, which are elevated in patients with traumatic brain injuries.
FDA predicts the test will enable doctors to bypass CT scans for one-third of patients with suspected head injuries.
FDA reviewed and authorized the test in under 6 months through its breakthrough devices program. The goal is to expedite the test to be in used in the continental U.S. as well as foreign U.S. laboratories that service the American military.