The saga of U.S. FDA regulation of clinical decision support (CDS) software has spanned six years since the passage of the 21st Century Cures Act, yielding two FDA draft guidances and a final guidance that emerged only Sept. 27, 2022. Regulatory attorney Brad Thompson blasted the final guidance for its addition of “time-critical decision making” to the definition of a regulated medical device, one of several features he argued are extra-statutory and which effectively handcuff both developers of CDS and the physicians who use their products to aid in selecting drug and device treatments.
The COVID-19 pandemic may or may not be over, depending on which member of the U.S. government’s executive branch one asks, but the FDA’s device center has drawn much tighter lines around its emergency use authorization (EUA) program for COVID-19 tests.
The U.S. FDA’s final report for the software pre-certification (pre-cert) pilot program for software as a medical device (SaMD) highlighted a number of both positive and negative developments, but the agency reiterated its call for new statutory authorities for review of SaMD. However, the agency also acknowledged that the pilot was itself compromised by the absence of that statutory authority because the absence of such authority means that the results of these mock product reviews cannot be legally walled off from non-pilot applications.
Legislation to reauthorize a number of U.S. FDA user fee programs has once again languished until the 11th hour, but the House and Senate committees of jurisdiction have apparently come to terms over the matter. However, the parties to this deal are characterizing it as a “clean” bill, which suggests that FDA regulation of lab-developed tests (LDTs) and a center of drug manufacturing of excellence will have to wait for another day or – because of the upcoming mid-term elections – most likely another year.
Clearpoint Neuro Inc. said Clinical Laserthermia Systems AB (CLS), snared a 510(k) from the FDA for a laser interstitial therapy system that will be marketed in the U.S. as part of the Clearpoint Prism Neuro system. This product package adds to a growing Clearpoint footprint in the neurological disorders space, adding to an inventory that already consists of targeted drug delivery and deep brain stimulation systems.
With FDA 510(k) clearance of its Kinguide robotic-assisted surgical system, Point Robotics Medtech Inc became the first robotics company in Taiwan to gain U.S. clearance for an orthopedic surgical robot.
Colorectal cancer (CRC) is expected to increase steadily through the decade to reach more than 2.2 million cases and 1.1 million deaths by 2030 as two concurrent trends tick up—an aging population, that typically has higher rates of the disease, and an alarming increase in cases in younger people. Iterative Scopes Inc. hopes to help gastroenterologists find precancerous lesions before they progress with its Skout device, which received U.S. FDA 510(k) clearance this week.
The U.S. FDA posted notice recently regarding a vulnerability seen in the Minimed 600 series of insulin pumps made by Dublin-based Medtronic plc, which exposes the user to the risk of unauthorized access to the pump’s software. The vulnerability could be exploited to interfere with the system’s ability to deliver only the desired amount of insulin, although the FDA acknowledged that no adverse events or complaints have been reported.
The U.S. response to the emergence of the COVID-19 pandemic may by now be the stuff of public health policy lore, with both the FDA and the CDC contributing to the chaos in the first months of the pandemic. The Office of Inspector General has issued an analysis of the situation, and while OIG revisited some of the known miscues, the report also made the case that a national strategy for pandemic response will be needed if federal government efforts in the future are to be less a hazard to the lives of American citizens than those seen in the first half of 2020.
