Though the FDA has been very strict about the process of approving medical mobile apps and devices, there are many products and apps that have won approval from both the organization and the target audience they have been created for. Apple iPhones and BlackBerry devices, as also their respective apps, have been of immense use to medics and paramedics working in emergency situations. In this article, we bring you useful tips to help get your mobile device approved by the FDA.
As most of you are aware, the FDA follows strict guidelines to define medical devices and, more importantly, to classify which mobile phone becomes an FDA-regulated medical mobile device.
According to the FDA Guidelines, a mobile phone could be classified as a medical device if it falls in any of the following categories:
As against certain accessories that are sold wholesale in the open market, an actual medical mobile device has to acquire some form of premarket approval from the FDA. How do you go about this?
Here are steps you need to take in order to get clearance for your medical mobile device or component:
Categorize Your Product
The FDA has clearly stipulated several categories for medical mobile devices and accessories. The organization also gives you a wide database of regulations pertaining to each category of these devices and components, through their Website. These are clearly indexed and presented to you, thereby making it much easier for you to browse all of them and choose the exact category that you are looking for. While the most vital hardware and software categories are listed right in the beginning, you can find the other minor categories after a more detailed search. Make sure to study and understand all the requirements of the category you are interested in.
Here is one important thing to note during your search. In case you cannot find a category that describes your particular product, it will most probably feature as an accessory and will feature under a parent device category.
Select Your Product Class
The FDA classifies medical mobile devices and accessories into three categories, namely, Class I, Class II and Class III devices. This classification has been done taking into consideration the risk factor of the product in question. While Class I devices are considered to be the least risky, Class III products will come heavily under the scanner.
While some Class I devices are totally exempt from regulatory stipulations, most of the Class I and Class II devices will need you to file some form of premarket notification. Note that all Class III devices will need premarket approval – something that can be expensive both in terms of time and money. Also, if your device falls under the accessory tab, it will be subject to all the regulations of its own parent device category.
Gather Evidence for FDA Clearance Claims
Clearly state the purpose that your medical mobile device is intended to be used for, claiming the function that your product is capable of delivering, or stating the medical condition that it can be used to treat.
Next, you will have to present clinical evidence to prove that your product actually works as claimed by you. This can get complicated, as the device needs to be thoroughly tested under controlled clinical conditions.
Stick to Quality Control Requirements
The FDA, as you know, is very particular about adhering to its quality control stipulations. These regulations ensure that manufacturers produce only quality products, which also minimizes the risks involved in the actual use of the product. One important thing to remember here, is that the quality control regulations apply right from the time you conceptualize your product; design, develop and finally manufacture it.
These requirements even extend to post-sales issues, such as user feedback, compliant, risk management, failure analysis and so on. While product inspections may follow as a result of these quality regulations, they are in place, mainly to see to it that the entire process of production and distribution of the product is smooth and trouble-free.
The FDA further stipulates that companies remain vigilant for user complaints regarding the quality or functioning of the product. In case of a complaint, the manufacturer should keep ready all the necessary systems for the product review, with all reports to be filed under an Adverse Event. You may also have to inform the FDA if you make corrective changes to your product.
In Conclusion
While the above restrictions and regulations posed by the FDA may seem rather cumbersome, it is to ensure that the user is benefitted by the use of your medical mobile device.
