On May 15, 2012, the U.S. Food and Drug Administration (“FDA”) announced the clearance of expanded uses for the FilmArray Respiratory Panel, a medical device used to detect causes of respiratory infection. Manufactured by Idaho Technology, Inc., the device is cleared for the simultaneous detection of both viral and bacterial causes of respiratory infection. The device was originally cleared by the FDA in 2011 to detect only viral causes of respiratory infection. Now, with the expanded panel, the device is cleared to concurrently detect 17 viruses and three bacteria.
The FDA’s regulation of medical devices follows a three-tier approach. Class I devices, or the least-risky devices, typically do not require notification to the FDA prior to marketing. At the other end of spectrum, Class III devices are largely required to undergo the premarket approval (“PMA”) process. While Class II devices typically do not require a PMA, most of these devices must be cleared for marketing by the FDA through the premarket notification (“510(k)”) process. Through this process, device sponsors must notify the FDA of their intent to market a device, while demonstrating that the candidate device is substantially equivalent to a device that has been marketed prior to May 28, 1976 (the date of the Medical Device Amendments) or to devices that have otherwise been reclassified under the Federal Food, Drug and Cosmetic Act (“FFDCA”) and do not require a PMA. More information about the FDA’s classification of medical devices may be found here.
Once a device has received FDA clearance through the 510(k) process, it is then subject to continuing monitoring by the FDA whether through reporting requirements or through adherence to Quality System Regulations (“QSRs”). Additionally, if a device that has been cleared undergoes a modification that bears upon its safety and effectiveness, the device sponsor may need to submit another 510(k) in order to continue legally marketing the device. More information about modifications to cleared devices may be accessed here.