Medical Devices: FDA-Cleared vs. FDA-Approved

To be sold legally in the United States, a medical device must be either cleared or approved by the FDA. Both “FDA-cleared” and “FDA-approved” provide a reassuring and lofty appeal to the casual observer, but the difference in these terms is stark and significant.

FDA-approved medical devices must undergo testing carried out on humans along with meeting stringent standards (note, however, that the manufacturers are tasked with performing their own clinical testing in pursuit of approval). FDA-cleared medical devices, on the other hand, are those that have been determined by the FDA to be substantially similar to another legally sold medical device. The practical effect is huge – with only one class of devices having undergone direct, device-specific testing.

Unlike with FDA-approved devices, no human testing is required for FDA-cleared devices. Instead, companies must submit a 510(k) to the FDA for review.

 The 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, in other words, substantially equivalent, to a legally marketed device that is not subject to premarket approval. The 510(k) pathway is a system created by the FDA exempting companies from more thorough device testing as long as they are substantially similar to a product that has come before. The intention of this system was to ensure innovation was not impeded, but it also inadvertently made possible a method allowing devices to be similar to past devices dating from decades before, to the point where the differences could outweigh the similarities. Once a 510(k) submission is approved and the device is FDA-cleared, future 510(k)

submissions can refer to this latest FDA-cleared device; they are not required to refer solely to FDA-approved devices for support. Because 510(k) submissions are not required to make “primary” references to FDA-approved devices, successive layers of FDA-cleared devices will emerge that rely on an ever-lengthening historical chain of FDA-cleared devices. This dilutes the value of 510(k) submissions, much like the way that copying copies of keys over and over compounds minor distortions and ultimately results in a useless key. Translated to medical devices, as the differences between the devices compound in 510(k) submissions over time, we know less and less about the safety and efficacy of medical devices on the market. Today, the majority of medical devices on the market are FDA-cleared, not FDA-approved.

According to the Internal Consortium of Investigative Journalists, over the past ten years there have been upwards of 1.7 million injuries and 80,000 deaths potentially relating to medical devices. Many of the devices involved were FDA-cleared as opposed to FDA-approved, and had not been tested in a clinical trial setting prior to being implanted in patients. A recent example of the potential risks of FDA-cleared medical devices is the 2018 case of DePuy Synthes, a franchise of orthopedic and neurosurgery companies.

DePuy Synthes had developed a hip replacement procedure using a metal ball and socket,  which was FDA-cleared as it was deemed to have substantial similarities to six previous devices, and shared traits with devices from as far back as 1975. Despite FDA-clearance, the metal hip devices experienced degradation problems and high failure rates; the resulting damage to patients caused by DePuy’s metal hip devices has resulted in over $3 billion in settlements. These damages, along with complaints by patients, led to the FDA revoking FDA clearance for the devices and forcing the manufacturer to seek FDA approval.

by Kalyan Emerick

5G: What is it, What Makes it Different, How does it Impact Cybersecurity, and Is it Safe?

5G refers to the fifth generation of wireless technology, and offers three main improvements over the current 4G standard: greater speed, lower latency, and higher bandwidth. The 5G radio system, known as 5G-NR, is not compatible with 4G, but the first 5G phones will keep 4G as a supplement while 5G coverage spreads. Despite the arrival of 5G, 4G technology can and will continue to improve in terms of speed, keeping it comparable in that regard. The pressure on tech companies to demonstrate that they are on the forefront of the latest technology is fierce, leading some companies to make 5G-like references to what are actually improvements in their 4G technology, such as AT&T’s “5G Evolution.”

What makes 5G promising is its massive capacity combined with low latency beyond what can be achieved with 4G. Latency is defined as the time it takes for a source to send a packet of data to a receiver, and is typically measured in milliseconds. Taking advantage of larger clear blocks of airwaves than were available for 4G, the 5G network can operate on much larger channels than 4G, allowing it to carry higher speeds. The 5G network will also be able to leverage wider bandwidths and advanced antenna technologies to boost capacity over current systems. This affords a 5G network higher speeds and higher regional capacities, all at a lower latency than 4G. The higher bandwidth and lower latency of 5G means more potential for streaming and connected services. For example, due to bandwidth and latency restrictions with the current 4G network, driverless cars are held back in utility as they can only control themselves and are unable to communicate with other cars. The increased bandwidth and low latency of 5G would make possible the large-scale level of device communication and instant response time required for connected driverless cars on the road.

The wide array of new services made possible by improvements brought with 5G will bring new security concerns as well. One area of concern is the increased bandwidth of 5G; the increased communication made possible by 5G will require stricter security measures for smart home appliances, among other things.

Regarding safety concerns for the new 5G network technology, 5G uses millimeter wave frequencies which are shorter than the typical frequencies used by 4G and Wi-Fi signals, and therefore, higher in energy. 4G LTE can use frequencies of around 2.5 GHz, while Wi-Fi uses frequencies of around 5 GHz. In contrast, the millimeter wave frequencies used by 5G can be as high as 300 GHz. This extra energy output raises concerns of potential unknown health risks associated with 5G. However, under current scientific and medical reasoning, to cause damage, radiation must be high enough to be considered ionizing. Despite having a much higher energy level than 4G or Wi-Fi, the energy put out by 5G networks does not come close to this threshold. Whether advances in science and medicine lead to changes in this understanding remains to be seen.

by Kalyan Emerick

Iranian-American Civic Leadership: Parisa Dehghani-Tafti Beats Incumbent to Win Northern Virginia Commonwealth’s Attorney Primary

Last month, the Iranian-American Chamber of Commerce highlighted the campaign of Iranian-American Parisa Dehghani-Tafti, the nominee for commonwealth’s attorney in the Northern Virginia counties of Arlington and Falls Church. The commonwealth’s attorney serves as the elected prosecutor of felony crimes in Virginia (in most states, the job is referred to as a “district attorney”).
 On June 11, Virginia held its primary elections, in which Dehghani-Tafti ran against the two-term Democratic incumbent, Theo Stamos, who held the position for seven years. Dehghani-Tafti ran on a platform of criminal justice reform, and won the primary with 52% of the vote.

In response to her primary win, Dehghani-Tafti tweeted, “I am humbled and honored at the trust the voters of Arlington and the City of Falls Church have placed in our campaign. This election wasn’t about me but about the community’s recognition that criminal justice reform is one of the civil rights issues of our time.” Virginia’s general election will be held on November 5, 2019.

by USIRC Staff