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Regulatory News | 03 August 2015 | By Michael Mezher
While the Congress is busy working on the 21st Century Cures Act, which is expected to speed access to new drugs and devices, a new report from EP Vantage shows FDA isn't sitting on its hands.
In the first half of 2015, FDA has already cleared 26 devices with either premarket approval (PMA) or a humanitarian device exemption (HDE).
To put that in perspective, in half a year FDA has already granted more PMAs and HDEs to new devices than it did in 2009, 2010 or 2013. At this rate, the agency is on target to clear more such devices than in any individual year in the past decade.
FDA regulates medical devices based on their level of risk, and allows companies to clear new low-risk products by demonstrating their similarity to already cleared devices. For high-risk (Class III) devices, companies must complete a PMA to demonstrate their device is safe and effective.
HDEs are similar to PMAs, except they are granted to devices that treat or diagnose rare diseases and conditions, and do not require companies to prove effectiveness. For devices, FDA defines rare as affecting "fewer than 4,000 individuals" in the US per year.
According to EP Vantage, the average review for devices granted a PMA or HDE took 17.1 and 16.7 months, respectively.
Aside from having a productive year for device reviews, FDA has also taken steps to reduce the time it takes to review certain devices and reduce the level of regulatory oversight for others.
In April, FDA finalized a new expedited pathway for medium- and high-risk devices that meet an unmet need for certain serious medical conditions.
Then, in June, FDA announced it would exempt some 120 classes of low-risk devices from premarket notification requirements, making it substantially easier to bring devices in those classes to market.
Tags: Humanitarian device exemption, Premarket approval