Mobile medical applications now have fantastically evolved whopping social media and online gaming. At large this advanced feature widely dominated healthcare professionals and even medical doctors.
Somehow there is an underlying flaw behind these advantages. The Food and Drug Administration (FDA) has arrived to strictly regulate if not prohibit the use of mobile medical apps as a class regulation.
In an interview made by Emergency Medicine News, the FDA spokesperson said that the use of mobile medical applications to diagnose and treat patients is revolutionizing health care. It was quoted in the interview that FDA has a public health responsibility to oversee the safety and effectiveness of a small subset of mobile medical applications that present a potential risk to patients if they do not work as intended. Thus, FDA has the responsibility to intervene and take on all the possible consequences to control the matter.
The FDA issued a draft guideline which includes the list of applications subject to the review process. They will inspect medical devices for medical apps that act as its accessory and also those applications that transform a mobile device into a medical device.
Some of the applications that fall under the regulatory oversights are applications that allow the user to view medical images, such as digital mammography or digital images of potentially cancerous lesions on a mobile platform, and those that perform a health analysis or provide a diagnosis by trained health care professionals, applications that allow the user to view patient-specific lab results and applications that connect to a home use diagnostic medical device to collect historical data, or to receive, transmit, store, analyze, and display measurements from connected devices. These applications present potential risks to patient, while those other majority of mobile apps will be sustained.
Mobile application that have been under regulatory oversight will come to division of three categories such as class I, II and III, while electronic copies of medical textbooks or teaching aids, log and evaluate statistics related to general health and wellness and generic aids to simply assist users will not be needing FDA review.
According to FDA spokesperson, mobile medical apps that have been submitted to FDA have already been distributed in the market. These applications have two classifications: Class I devices and Class II devices. The apps that have complied with general manufacturing registration requirements which no longer need premarket review and high risk mobile medical apps that will require premarket approval (PMA) respectively. FDA anticipates encountering more Class I and minimal Class II mobile medical applications. By far they have not encountered Class II’s yet.
The review process cost money, and one of the main concerns of mobile medical app developers, some of whom happen to be clinicians, is that this new regulation should not negatively affect their finances as they ensure to give safe and quality health care.
Dr. Harvey Castro, an emergency physician and also an app developer believed that prioritizing the safety of every patient is the most important, though he knew that many will be affected, especially small businesses and entrepreneurs. He added that the new regulation will injure independent manufacturers making way for big companies who are more financially stable and can afford the high cost of the regulation process to dominate the market.
There is no definite deadline for the regulations to take effect yet. FDA is willing to review and hear out commendations on the draft of the guidelines they construed last October. Nevertheless FDA is not against the constant development of mobile medical apps and they do not intend to suppress modernization by heaping taxing regulations.
Medev Rob is one of the consultants at BNR Medical Device Approvals. Visit their website if you need expert help with FDA Registrations.