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.

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: mHealth App Trends that are Changing the Face of Healthcare

🔸 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?

4. DR Compliance and Data Backups

In the realm of disaster recovery (DR) compliance and data backups, the primary objective is to establish measures that guarantee business continuity and enable seamless data recovery in the event of a disaster or outage. The critical aspects focus on protecting business operations and mitigating potential disruptions caused by unforeseen events.

🔸 EC2 Backup Policies

Creating backup policies for EC2 instances is important to ensure that your critical data is backed up regularly to protect against data loss in case of any disaster or outage.

🔸 RDS Backup Policy and Multi-AZ Setup

RDS (Relational Database Service) is a managed database service provider by AWS that helps healthcare providers simplify the setup, operation, and scale of relational databases in the cloud. The backup policy includes setting up a backup, which is a periodic snapshot of the database. It determines the frequency and retention of periods of these backups.

On the other hand, Multi-AZ setup or deployment is a high-availability feature provided by AWS RDS. The AWS automatically replicates your primary database to a standby instance in a different availability zone. We are going to apply the RDS backup policy and Multi-AZ setup to achieve compliance in our healthcare product.

  • RDS Backup Policy: Setting up a backup policy for your RDS instances allows you to create automated backups and snapshots of your data, which can be used to restore your database in the event of an outage or data loss.
  • Multi-AZ Setup: Multi-AZ setup is a feature of RDS that allows you to create a standby replica of your database in a different availability zone. This provides high availability and automatic failover in the event of a disaster or outage.
🔸 S3 Versioning, Archival, and Cross-Region Replication

  • Versioning: Enabling versioning for your S3 buckets allows you to preserve, retrieve, and restore every version of an object in the bucket, which can be useful in the event of accidental deletion or modification of data.
  • Archival: Archiving data in S3 Glacier or S3 Glacier Deep Archive can be a cost-effective way to store infrequently accessed data for long-term retention.
  • Cross-Region Replication: Enabling cross-region replication for your S3 buckets allows you to replicate objects across different regions, which can help you meet compliance requirements and provide high availability and durability for your data.
Ensure that Your Healthcare System or Product Adheres to Compliance Standards

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:

Infographic for 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 requirements.

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.

Frequently Asked Questions

Do mobile apps need FDA approval?

Not all mobile apps need FDA approval. The FDA regulates apps that function as medical devices, meaning they are intended to diagnose, treat, or cure a medical condition. However, apps for general wellness tracking or appointment scheduling typically don't require FDA approval.

Does software as a medical device require FDA approval?

Yes, software as a medical device (SaMD) may require FDA approval depending on the risk it poses to patients. The FDA uses a risk-based approach, so high-risk SaMDs that significantly impact health decisions need approval, while lower-risk tools like appointment schedulers likely wouldn't. The FDA offers resources to help developers determine if their software qualifies as a medical device and the approval process it might require.

What is the difference between FDA compliant and FDA approved?

FDA approval is a stricter designation than FDA compliance. FDA approved medical devices have gone through a rigorous testing process to ensure safety and effectiveness for their intended use. FDA compliance, on the other hand, indicates a product meets general safety standards and doesn't necessarily guarantee effectiveness for a specific medical purpose. Think of approval as a thumbs-up for both safety and efficacy, while compliance is just a green light for safety.

Meet the Author
Manisha Khadge
Manisha Khadge, CMO Mindbowser

Manisha Khadge, recognized as one of Asia’s 100 power leaders, brings to the table nearly two decades of experience in the IT products and services sector. She’s skilled at boosting healthcare software sales worldwide, creating effective strategies that increase brand recognition and generate substantial revenue growth.

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