REGULATORY STRATEGY
WHY IT IS APPROVABLE
Our device is focused to sell only in the United States; therefore, it solely follows the FDA and FCC regulations. Since the device does not support or sustain life and it does not present a great risk for patient illness or injury, it is classified as a Class II medical device. Due to the device’s classification and its similarities to other predicate devices, our product is considered substantially equivalent. These predicate devices include a non-invasive blood pressure monitor worn on the wrist and a standard protein urine analysis testing kit. Our device will monitor the markers for preeclampsia in pregnant women, and will notify the expectant mother when these levels indicate that the disease may be present and further testing at a clinic is recommended. Also, in accordance with the FCC, our device is subject to the wireless telecommunication regulations for its Bluetooth capabilities and regulations for the device’s image processing and data storage functions.
INTENDED USE AND INDICATIONS FOR USE
The product’s intended use is to monitor a pregnant mother’s blood pressure and protein levels in her urine. This device will alert the expectant mother if there are signs of preeclampsia, so that she may choose to obtain further testing from a clinic.
Its purpose, or indications for use, is to detect signs of preeclampsia in pregnant women early on in order to lessen the severity of the disease.
MEDICAL DEVICE AND CLASS
This product will help identify signs of preeclampsia in pregnant women. With its purpose for early detection of preeclampsia the device will help to reduce the severity of the disease. As defined by the FDA, our product is classified as a medical device because it mitigates the disease.
This device is a Class II medical device; it is at a greater risk than Class I devices, however, it does not pose an unreasonable risk of illness or injury to the user. The blood pressure monitor makes the overall device Class II since predicate non-invasive blood pressure monitors are Class II devices. Additionally, the picture archiving and communication systems are considered Class II by the FDA. Although the urine protein analysis using the colorimetric assay and medical imaging properties of the device are Class I, the other functions of the device are Class II; therefore the overall device is Class II.
REGULATORY PATHWAY
A premarket notification 510(k) will be required for the non-invasive blood pressure monitor. The blood pressure monitor is substantially equivalent to other non-invasive monitors that are worn on the wrist (regulation number CFR 870.1130), so no clinical trials are necessary. The protein urine analysis is substantially equivalent to another Class I device (regulation number CFR 862.164) and therefore exempt from 510(k) process. Non-clinical bench testing will be required to test the non-invasive blood pressure monitor. Such testing includes mechanical and electrical durability, accuracy, efficiency, and functionality. Bench testing for the mobile app component will also be necessary in order to confirm its low risk.
As a Class II device, the product is subject to both General Controls and Special Controls. Special Controls include: performance standards, post market surveillance, premarket data requirements (non-clinical bench testing), and guideline documents. Our product also complies with the QSR (Quality System Regulation) including GMP (Good Manufacturing Practices). The apps available for download on personal mobile devices will be subject to the FDA’s enforcement discretion. They are not regulated by normal FDA CFR rules because although these apps “[may] meet the definition of a medical device… they pose a lower risk to the public” and therefore are subject only to enforcement discretion [3]. In addition, the wireless telecommunication components of our device, as defined in eCFR Section 15.3(z), will be subject to the FCC’s rules for RF unintentional radiator devices [4, 5].
REMAINING CHALLENGES
The growing number of uses for wireless technology in medical devices has led to more and more steps being taken to ensure the safety of those using it. While our technology uses the simple principles of wireless communication, we will continue to strive to provide the utmost security for our patients. Aside from the growing advances in the Bluetooth communication, and the cyber security that accompanies it, our goal will be to increase the effectiveness of our image processing for the colorimetric assay tests. As the cameras on personal smart devices increase, the processing power of our imaging software will become more accurate. With each new advancement in our product’s digital software new and different regulations arise, however, our team will continue to stay within the requirements for safety and effectiveness as mandated by the FDA.