Can FDA regulation of mobile apps stifle innovation?

Advancements in the mobile industry have introduced a wealth of new applications for smart phone users. Many apps are dedicated to life improvement, concentrating on aspects like healthy living, weight loss and exercise. Individuals can rely on these solutions to become more aware of their health and advance toward their fitness goals. A segment of the app industry has recently fallen under scrutiny recently because of the risks of information provided in these apps.

FDA scrutinizes mobile apps

Mobile apps could potentially be a risk to consumers. The FDA has recently decided to focus its attention on building better apps. Some of the mHealth apps will be treated as medical devices. The move is designed to improve public safety. The goal will be to assure the safety and quality of the apps while minimizing health risks to users. They can pose a risk to the public safety is the apps are used as they were intended to be.

What defines a mobile medical app?

The FDA defines a mobile medical app as a device that provides consumers with health-related information. Some mobile medical management apps are specifically designed to function as a diagnostic tool for health practitioners. Mobile medical apps are those that can be defined as a medical device. Items that function as an accessory to a regulated device fit into this category. The definition extends to a mobile device in which the mobile platform is transformed, ultimately becoming a regulated device. Although these apps can improve health care across the board, a person can be at risk if used incorrectly.

What are the classifications of mobile medical apps?

Class I apps are considered less risky than the other profiles. These mobile medical apps do not have to be marketed. Class II apps are considered moderately risky. Creators of these apps have to file a pre-market notification and notify the FDA of its plans to market the app as a medical device. The notice has to be filed with the FDA 90 days in advance. The final group is the Class III app, which carries more risks. These apps require approval by the FDA before they are allowed to be marketed as a device. The products are reviewed to measure safety and effectiveness of the product.

Response to regulatory practices

App developers now have to become knowledgeable of the regulatory processes. The FDA regulation process has been criticized as being a potential threat to innovation. Others welcome the change given the various safety risks a person can be exposed to in using these faulty apps.

Mobile applications have transformed the wellness industry in promoting a healthier lifestyle for consumers. Individuals who rely on these apps can use these solutions to improve their health, achieve their goals or clothing and wellness products. While many of these apps are harmless, the mobile medical device category of wellness apps puts a person at risk. If a person can potentially misuse the app or use it as a medical device, the FDA wants to ensure that it meets certain quality standards.

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