The Food and Drug Administration has ruled that some products of health IT are not the same as medical devices and thus not subject to healthcare regulations. This according to the agency’s April publication of a framework
According to the Federal Times:
The FDA declaration goes even further, noting that even IT products that straddle the line still will be exempt. “For most health IT products that may be considered devices, FDA does not intend to focus its oversight on them,” said Bakul Patel, senior policy advisor for the FDA’s Center for Devices and Radiological Health.
Mobile Medical App is a category of mobile apps defined by FDA as “apps that consist of features of a regulated medical device by using attachments, sensors, or other such methods”.
Some examples of mobile apps that fall in this category include:
- Mobile apps that connect to medical devices to control them or to display, store, analyze or transmit patient specific medical device data.
- Mobile apps that transform a mobile platform with device functionality by using attachments, display screens, or sensors.
- Mobile apps that perform patient specific analysis and provide patient specific diagnosis or treatment recommendations.
- Mobile apps that use patient specific parameters to calculate dosage or create dosage plans for radiation therapy
Classification of Mobile Medical Apps:
Mobile medical apps have been classified into 3 categories:
Class I: No FDA review required and are considered least risky. For such devices, as long as they meet FDA-set standards they are ready to be marketed.
Class II: They are considered to be moderately risky. This category of devices requires the manufacturer to file pre-market notification. Pre-market notification means that the device manufacturers will be required to notify FDA of their intent to market a medical device at least 90 days in advance.
Class III: They are considered to be highly risky and will be under FDA scanner. Class III devices will need premarket approval. This is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. They may be defined as apps that support human life, play a critical role in preventing impairment of human health, or which presents a potential risk of illness or injury. These devices almost always must be approved by FDA before they are allowed in the market, and typically rely on the evidences obtained through clinical testing (i.e. on humans) to prove that they are safe and effective.
Mobile apps, entities, activities not under purview of FDA regulation
Examples under this category include:
- Entities that distribute mobile apps such “iTunes App store” or the “Google Play store,” are not considered as medical device distributors by FDA
- Mobile apps developed solely for non-clinical research, teaching or analysis and not introduced into commercial distribution
- Mobile apps that are essential e-copies of medical textbooks and reference material
- Mobile apps used for provider or patient medical training and education
- Mobile apps used to automate operations in a healthcare setting and not for use in the diagnosis or treatment of disease (i.e., (i.e., dosing reminders, scan-to-refill, e-diaries, sign-and‐send e-forms, and multi- language options)
Mobile apps that function as an electronic health record (EHR) system or personal health record system.
Peter J. Pitts, Ph.D.
Chief Regulatory Officer