With the introduction of the 21st Century Treatment Act, developed by the US House of Representatives and the Senate, patients will be able to access new medical technologies faster and more easily, as evidenced by the number of approved medical devices in the first half of 2015.
In the first half of the year, 26 medical devices have received pre-market approval or tax deductions. This year, it is expected to see more new products being approved for the market than in the past decade (see Figure 1).
Approval of speeding security is questioned
The rapid approval process for the US FDA device approval PMA path came into effect in April. However, this measure is currently not popular with the public. An editorial in the New York Times on July 17 pointed out that because the 21st Century Treatment Act lowered the consideration of clinical data, it may lead to the approval of less safe medical technology.
This warning was made by two cardiologists. To date, 11 cardiac device approvals have been approved in the heart disease treatment field this year through the PMA Rapid Approval Channel and the HDE Device Review Channel (Humanitarian Device Exemption), the same number as in 2014.
The average length of approval for cardiac diagnostic devices in the first half of 2015 was 15.2 months, which was 17.1 months faster than the average length of approval for all types of devices. In addition, the length of approval for diagnostic imaging and wound healing management equipment is also shorter than average.
It is also questionable whether the FDA's review and approval of new and high-risk equipment is sufficiently rigorous. However, the industry generally believes that FDA approval requirements are more stringent than European regulators. It is worth noting that in the first half of 2015, the average approval time for all equipment that passed the PMA or HDE channel was 17.1 months, which was slightly longer than the 16.7 months last year.
The HDE channel appears to be more efficient than the PMA. The humanitarian device exemption channel is specifically designed for the approval of medical devices for rare diseases. This approval process can be applied for the approval of instruments and equipment with fewer than 4,000 patients. Kaneka's Lixelle, a blood filter for the treatment of a rare disease of chronic kidney failure caused by protein folding, took more than two years to get HDE channel approval, and Abiomed's Impella The RP right ventricular heart pump took only 4.4 months to get approved through the HDE channel. This is the only two HDE channel approvals in the first half of 2015, which reduced the average length of these approvals to 14.7 months, much faster than the 17.3 months of the PMA channel.
Incentives for innovation have achieved remarkable results
Low-risk devices are usually approved through the 510(k) channel and are another faster new de novo clearance for devices that are open to those that differ from previous technologies. In the first half of 2015, there were 10 devices that passed the innovative medical device approval process, which was only slightly lower than the previous annual average.
The innovative medical device approval process has relatively low security and effectiveness. Eligible products have a low-to-medium risk, and their safety and effectiveness should be “reasonable.†The developer must indicate the known risks and effects of the device and provide evidence to show that the risks are effectively mitigated and their effectiveness is guaranteed.
Therefore, there are some novel new medical devices that enter the market through this route. The BrainPort V100, developed by Wicab of Wisconsin, USA, helps blind people locate and move. The system includes a set of electrodes fixed by the user's mouth, which is coupled to a pair of sunglasses with cameras mounted thereon. The pixels in the camera video can be converted into electrical pulses, and the patient perceives through the tongue. Some user experience means that it feels like a tiny bubble.
The fastest-launched innovative medical devices will become the world's newest top products. The sharable Auxiliary Display Application APP, developed by DexCom, became the first mobile app to be approved as a medical device. It was approved by the FDA on January 26 this year, with patients and their caregivers. Use different APP types separately. This product, which allows users to continuously monitor changes in their blood glucose levels, has a lead time of only 1.3 months.
This timetable may be refreshed soon. It is foreseeable that more new devices will be approved in the second half of 2015, and a new record will be refreshed in 2015.
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