FDA Compliance for Mobile Health Apps: What You Need to Know

Today mobile health apps have become increasingly popular among healthcare professionals and patients alike. The apps provide a range of benefits, such as improved patient engagement, remote monitoring, and personalized care. Mobile health apps provide healthcare services, track health data, and offer medical advice, among others.

However, with the increasing use of mobile health apps, it is essential to ensure that they comply with FDA regulatory standards. FDA compliance with mobile health apps is critical to ensure their safety and effectiveness for patients.

We will explore FDA compliance for mobile health apps and what app developers need to know to ensure compliance. We will discuss the different types of mobile health apps and how they are regulated by the FDA. Additionally, we will examine the challenges app developers face in achieving compliance and offer tips for overcoming these challenges.

Before diving into the details of FDA compliance for mobile health apps, it’s essential to understand what FDA compliance is.

What is FDA Compliance?

The FDA is a regulatory authority responsible for ensuring the safety, efficacy, and security of human and veterinary drugs, medical devices, food, cosmetics, and other products. FDA compliance refers to the set of regulations and guidelines companies must comply with to ensure their products are safe and effective for customers.

For mobile health apps, FDA compliance means ensuring that the app meets the regulatory standards set by FDA to ensure the safety and effectiveness of the app for patients. The standards include pre-market review processes, post-market surveillance requirements, and compliance with other regulations, such as HIPAA and GDPR. By prioritizing FDA compliance, app developers can ensure safe and effective care to patients.

Understanding FDA Compliance for Mobile Health Apps

FDA compliance for mobile health apps refers to adherence to regulatory standards set by the FDA to ensure the safety and effectiveness of the app for patients.

Mobile health apps are classified into three categories based on their risk level: Class I, II, and III.

At ORCHA we’ve found only 20% of the 365,000 health apps available meet any kind of quality criteria. So we continuously assess health apps against hundreds of criteria in data and privacy (including HIPAA), clinical safety, and usability and accessibility. We provide formularies for healthcare providers and libraries for the public so they have a place to find health apps they can trust.

Liz Ashall-Payne,
CEO and Co-Founder of ORCHA

The FDA has issued several guidance documents for mobile health apps to help app developers understand regulatory requirements and comply with them.

For developers, prioritizing FDA compliance is crucial to ensure mobile health apps are safe and effective for patients. Non-compliance with FDA regulations and guidance documents can improve the app’s reputation and increase its chance of success in the market.

Many mobile apps don’t qualify as medical devices according to Section 201(h) of the FDC & Act. Only a small subset of apps- those intended for diagnosing disease or other conditions, or treating/preventing disease- are considered medical devices by FDA.

This includes,

  • Physical accessories that can attach to a regulated medical device (eg, electrocardiographic systems used to monitor cardiac rhythms),
  • Software that can transform a mobile platform into a regulated medical device (eg, laboratory information management systems),
  • A combination of software and physical accessories.

The guidance doesn’t address patient-specific analyses performed on mobile platforms to aid clinical decision-making.

What You Need to Know about FDA Compliance for Mobile Health Apps?

Mobile health apps have the potential to revolutionize healthcare delivery, but with that potential comes a responsibility to ensure that these apps meet regulatory standards for safety and effectiveness. Here are some key things you need to know about FDA compliance for mobile health apps:

Related Read: How mHealth is Transforming the Patient Care Process?

🔸 Pre-market Review Process

Before a mobile health app can be marketed in the US, it must undergo pre-market review by the FDA. The pre-market review process varies depending on the app’s risk level.

  • Class I devices are subject to general controls, which typically do not require FDA review before marketing.
  • Class II and III devices require pre-release clearance and approval, and the FDA has established different procedures for these devices.

🔸 Post-market Surveillance

Even after a mobile health app has been cleared or approved by the FDA, the manufacturer must monitor its performance. The manufacturer must also report adverse events to the FDA. Adverse event reporting is an essential part of post-market surveillance. It helps FDA identify safety issues that may not have been identified during the pre-market review.

🔸 Other Regulations

In addition to FDA regulations, mobile health app development must comply with other regulations that ensure patient privacy and data security. For example, HIPAA regulates the use and disclosure of protected health information, while GDPR applies to personal data collection, use, and storage. Complying with these regulations is essential to protect patient privacy and maintain trust in the app.

Related Read: How To Become HIPAA Compliant?

Ensure Compliance for Your Healthcare Application to Meet Industry Regulations

Challenges in Achieving FDA Compliance for Mobile Health Apps

Achieving FDA compliance for mobile health apps can be challenging for app developers, but it’s essential to ensure that these apps meet regulatory standards for safety and effectiveness. Here are some common challenges app developers face when achieving FDA compliance for mobile health apps:

Challenges in Achieving FDA Compliance for Mobile Health Apps

1. Lack of Understanding

Understanding regulatory requirements can be challenging for app developers, especially those new to the industry. This can lead to confusion and errors in the pre-market review process or post-market.

2. Limited Resources

Developing a mobile health app that meets FDA compliance standards requires significant resources, including time, money, and personnel. Many app developers may lack the necessary resources to meet the requirement.

3. Changing Regulatory Landscape

The mobile health apps regulatory landscape is constantly evolving, and keeping up can be challenging for app developers. For example, the FDA recently released its guidance document on artificial intelligence and machine learning in medical devices.

To Overcome these Challenges, App Developers can take the Following Steps

💡 Collaborate with Regulatory Experts

Working with regulatory experts with experience with FDA compliance can help app developers better understand regulatory requirements and navigate the pre-market review process and post-market surveillance.

💡 Use FDA Guidance Documents

The FDA has issued several guidance documents for mobile health apps that can help app developers understand the regulatory requirements and comply with them.

💡 Conduct Rigorous Testing

Rigorous testing can help app developers identify any potential safety issues before submitting the app for FDA review, which can help streamline the premarket review process.



FDA compliance is critical for mobile health apps as it ensures their safety, effectiveness, and reliability for patients and healthcare professionals. FDA compliance can be challenging for app developers, given complex regulatory requirements and a constantly evolving landscape.

However, by collaborating with industry experts, using FDA guidance documents, and conducting rigorous testing, app developers can overcome these challenges and make sure that their apps meet the necessary regulatory standards. It is essential to prioritize FDA compliance to ensure that mobile health apps provide high-quality care to patients, and app developers must continue to prioritize safety and efficacy to ensure the success of these apps in the healthcare industry.

Content Team

This blog is from Mindbowser‘s content team – a group of individuals coming together to create pieces that you may like. If you have feedback, please drop us a message on contact@mindbowser.com

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