The RealTime CMV Assay is a newly cleared device manufactured by Abbott Molecular, Inc. It was cleared on May 18th, of 2017, as a class 3 device. The RealTime CMV Assay, in its most basic form, “…is a laboratory test designed to measure the amount of cytomegalovirus (CMV) DNA that may be present in the blood of a patient who has undergone a bone marrow transplant.” (1). CMV is a human viral pathogen, and once you're infected you have it for life. “For people with compromised immunity, especially due to organ transplantation, CMV infection can be fatal.” (2). This virus affects approximately half of all bone marrow transplant patients, who then require anti-CMV therapy. Abbott looks to push this new product into hospitals and clinical settings to help those needing a diagnoses, or those managing one. Some technology associated with this device is actually manufactured by the same company, the Abbott m2000sp RealTime system and the Abbott m2000rt instrument for detection of the virus. This new device works by taking a sample of the patient's blood which is then spun to separate the Nucleic Acid (DNA) from the blood. The DNA is then mixed with reagents that are provided by the RealTime CMV Assay product, and the liquid is placed into the associated technology, the Abbott m2000rt instrument. The RealTime systems work to measure the amount of CMV DNA in the patient's blood sample due to “produced light measured by the analyzer after the completion of the reaction” (1). The company does say that the test results have to looked at along with doctor's supervision and other laboratory findings in order to determine the results.As stated previously, the company pushing this new product is Abbott Molecular, Inc. They are based out of Des Plaines, Illinois, and their slogan is “Innovations for Managing the Most Challenging Diseases and Molecular Laboratory Demands” (3). The company produced this newly cleared device, RealTime CMV Assay, which aims to help diagnose and manage CMV infections in bone-marrow transplant patients. In the Summary of Safety and Effectiveness Data (SSED) that Abbott provided to the Food and Drug Administration (FDA), they went more in depth as to what the product would do and how to use it. For example, in the section labeled Indications for Use they include a short paragraph describing the three different parts of the product: Abbott RealTime CMV Assay, Abbott RealTime CMV Control Kit, and Abbott RealTime CMV Calibrator Kit. As they described in the Device Description section: “The Abbott RealTime CMV assay is comprised of three kits which are provided separately: Abbott RealTime CMV Amplification Reagent Kit, Abbott RealTime CMV Control Kit, and Abbott RealTime CMV Calibrator Kit.” (1). They also included a section on Alternative Practices and Procedures, where they bring up 2 FDA approved in vitro diagnostics tests for the quantitation of CMV DNA. This device, RealTime CMV Assay, is approved as a class 3 device. This is important to remember because it means that this device is considered to be the most complex, and “…considered to be at the highest risk and therefore require more stringent regulatory controls to provide assurance of their effectiveness and safety.” (4). The company manufacturing it, Abbott Molecular Inc., decided to pursue FDA approval for this device by submitting a Premarket Approval (PMA) on October 4th, of 2016. The FDA gave the information provided to an advisory committee, the committee overseeing this product was Microbiology, and made a decision on May 18th, of 2017. The Abbott company received the official approval letter on June 1st, of 2017, which included the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) review of the product, including what it is allowed to be used for, what they must include on packaging, and reminders to obtain continued PMAs and that no changes are to made to the product without FDA clearance. The FDA approval letter is a very big step in pushing a product into market. Abbott Molecular Inc. received their clearance letter on June 1st, of 2017. The FDA approval letter is a very complex and strict paper to receive, as stated above it includes what it is allowed to be used for, what they must include on packaging, and reminders to obtain continued PMAs and that no changes are to made to the product without FDA clearance. The letter begins with the intended use of each component of the new product and reminds the company that this is the only use for each component. The FDA made it clear that the product is restricted to prescription use, which “…is necessary to provide reasonable assurance of the safety and effectiveness of the device.” (1). The FDA established expiration dating ranging from 12-18 months depending on temperature and kit. The continued approval of this PMA, which is important if you want to continue distribution, is subject to submission of reports once a year, as specified in different regulations. This annual report has to include a Unique Device Identification (UDI), which is required for all class 3 devices as of September 2014, and must provide: “…separately for each model number (if applicable), the number of devices sold and distributed during the reporting period, including those distributed to distributors.” (1). This data provided by the company is then used by the FDA in order to create context as to the frequency, or the commonness, of “adverse events”. The letter goes on to point out that any change in the product has to be cleared through the FDA and remind the manufacturer that there are still requirements not explicitly outlined in the letter for which the FDA governs distribution and marketing. The final notes include: “You are reminded that, as soon as possible and before commercial distribution of your device, you must submit an amendment to this PMA submission with copies of all final labeling.” (1), and leaves the reader with an email and phone number to contact if questions arise. From reading through all of the information that the FDA provides about newly cleared devices, I've had a lot of revelations. For one, I had no idea that all of this information was just sitting there, that you could learn everything about a new product by just clicking away on the FDA website. For another, the amount of paperwork and testing and chart building that a company has to produce for the new product to even be considered is both alarming and reassuring. It's nice to know that the FDA is truly looking out for the consumers' safety. I also saw that the company did a really good job of reiterating the importance of their device and how it would be used with other products that were already FDA approved. I think these points must have subdued the council as they were reading through the binders of paperwork.
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