Navigating FDA Approval: A Developer’s Guide to Building Compliant Healthcare Software

June 3, 2025

FDA approval for healthcare software ensures it meets safety, efficacy, and regulatory standards. It’s required for software classified as a medical device, involving risk assessment, documentation, and testing.

When developing healthcare software that could potentially qualify as a medical device, obtaining FDA approval is a crucial step. It ensures your product is safe, effective, and legally allowed to be sold or used in the US healthcare market.
For developers, the approval process can seem complex, full of regulations, classifications, and documentation requirements. Following the right FDA software guidance helps simplify this journey. But skipping it isn’t an option if your software falls under FDA oversight. This guide breaks down what you need to know: when FDA approval is required, how the process works, and what to consider during development to stay compliant from the start.

Does My Healthcare App or Software Need FDA Approval?

Healthcare software development does not necessarily need FDA approval. The key factor is whether your product qualifies as Software as a Medical Device (SaMD). The FDA defines SaMD as software intended for medical purposes, such as diagnosing, treating, or preventing a disease, without being part of a physical medical device.

Your software may need FDA approval if it:

• Analyzes patient data to diagnose conditions.
• Recommends treatment plans.
• Tracks vital signs for clinical decision-making.
• Provides alerts that could influence medical care.

It likely doesn’t need FDA approval if it:

• Helps patients track wellness goals (e.g., step counters).
• Sends appointment reminders.
• Offers general health education content.
• Manages billing, scheduling, or admin workflows.

To be sure, you need to assess:

• The intended use (what the software is meant to do).
• The risk level (impact on patient health if it fails).
• The claims you make in your marketing or documentation.

If your app makes medical claims or supports clinical decisions, the FDA will likely treat it as a medical device, requiring formal FDA approval before release. Developers should always review the latest FDA software guidance for software development to understand the nuances.

How Does the FDA Classify Medical Software?

If your software qualifies as a medical device, the FDA will classify it based on the risk it poses to users. This classification determines the level of regulatory control and the type of approval process you must follow.

The Three FDA Classes:

• Class I (Low risk)
  • Example: apps that provide general wellness tips.
  • Usually exempt from premarket approval, but still must follow basic controls like proper labelling and manufacturing practices.
• Class II (Moderate risk)
  • Example: apps that monitor heart rate or blood sugar and provide alerts.
  • Requires 510(k) clearance, showing your software is substantially equivalent to an existing approved product.
• Class III (High risk)
  • Example: software used for diagnosing life-threatening conditions or controlling life-supporting equipment.
  • Requires Premarket Approval (PMA), the most rigorous process with clinical data and in-depth review.

Why Classification Matters?

It determines the cost, time, documentation, and testing needed for approval. Misclassifying your product can lead to rejection, delays, or enforcement actions. Before starting development, define your product’s intended use and consult the FDA’s software guidance or a regulatory expert to determine its classification.

What FDA Guidelines for Software Development Should Developers Know About?

Once your software is considered a medical device, you must follow specific FDA regulations throughout its development and release. These standards ensure that the product is safe, reliable, and traceable.

Key Regulations to Understand:

• 21 CFR Part 820 (Quality System Regulation): Covers design controls, risk management, testing, and validation. You’ll need to document how your software is developed and maintained per FDA guidelines for software development.
• 21 CFR Part 11 (Electronic Records and Signatures): If your software stores or processes electronic records or signatures, this rule ensures they are secure, accurate, and auditable.
• Software Validation Requirements: The FDA expects proof that your software does what it’s supposed to do consistently and safely. This includes functional testing, performance testing, and verification steps.
• Labeling and Promotional Claims: Any claim you make about your product must match its intended use and regulatory classification. Overstating features can trigger enforcement actions.

What Is the FDA Approval Process for Medical Software?

Once you know your software is regulated, the next step is navigating the FDA’s approval process. The steps depend on how your product is classified (Class I, II, or III).

Main FDA Approval Pathways:

• 510(k) Clearance (for most Class II devices)
  • You must show that your product is “substantially equivalent” to an already approved device.
  • Requires technical documentation, testing results, and comparisons to existing products.
  • Timeline: ~3–6 months.
• De Novo Classification (for novel low-to-moderate risk devices)
  • Used when there’s no existing equivalent product, but the risk level is manageable.
  • After approval, your device becomes a reference for future 510(k) submissions.
  • Timeline: ~6–12 months.
• PMA – Premarket Approval (for Class III devices)
  • The most rigorous process is meant for high-risk products.
  • Requires clinical trials, extensive data, and detailed manufacturing information.
  • Timeline: 12+ months.
• Pre-Submission (Pre-Sub) Program
  • Optional but recommended.
  • Allows you to get FDA feedback early, before formal submission.
  • Helps reduce mistakes and rejections later.

Key Documents Needed:

• Product description and intended use.
• Risk analysis and mitigation plans.
• Software architecture and development process.
• Test protocols and validation results.
• Labeling and user instructions.

Each step must be fully documented. If anything changes after release (like new features), you may need to resubmit or update your approval.

How Can Developers Build FDA Compliance Software from the Start?

Building FDA compliance software is best done by integrating regulatory requirements into every phase of your development process. Waiting until the end to address compliance often leads to costly delays and rework.

1. Clearly Define Intended Use and User Needs

• Start by documenting exactly what your software is intended to do and who will use it.
• FDA approval hinges on your software’s intended use — it drives classification, risk assessment, and testing requirements.
• Include this in your Design History File (DHF) to keep traceability clear.

2. Adopt a Formal Software Development Life Cycle (SDLC)

• Follow an established SDLC framework (like Agile, Waterfall, or V-Model), but ensure it includes documentation at every stage.
• Maintain detailed records for requirements gathering, design specifications, coding, testing, and maintenance.
• The FDA expects traceability matrices linking requirements to test cases and validation activities.

3. Implement Design Controls as per 21 CFR Part 820

• Design controls are FDA-mandated processes ensuring your product meets specifications and user needs.
• Key activities include design input (requirements), design output (software code, user manuals), design verification (testing if output meets input), and design validation (confirming the final product meets user needs in the real world).
• Keep version control and change management strict to track every update or modification.

4. Conduct Risk Management Throughout Development

• Apply ISO 14971 principles to identify, analyze, and mitigate risks to patients or users caused by software failure or misuse.
• Document your risk analysis and mitigation strategies. This must be reviewed regularly and updated as the software evolves.
• Risk management ties directly into your testing and validation plans.

5. Perform Rigorous Verification and Validation (V&V)

• Verification ensures the software was built correctly (did you build it right?). This includes unit tests, integration tests, and system tests.
• Validation confirms the right software was built (does it do what users need?). This often involves clinical testing or user acceptance testing.
• Document all tests, results, defects, and fixes comprehensively.

6. Develop Comprehensive Documentation

• Documentation is critical to FDA approval and future audits. Include:
  • Requirements specifications.
  • Design documents and architecture diagrams.
  • Traceability matrices.
  • Test plans and reports.
  • Risk management files.
  • User manuals and training materials.
• Use document control systems to manage versions and access.

7. Use a Quality Management System (QMS)

• Implement a QMS compliant with FDA’s Quality System Regulation (21 CFR Part 820).
• This system standardizes processes, maintains records, manages audits, and ensures ongoing compliance throughout the product life cycle.

8. Ensure Data Security and Privacy

• Although HIPAA and the FDA are separate entities, the FDA expects that patient data handled by medical software is secure and reliable.
• Incorporate encryption, access controls, audit trails, and secure coding practices early on.

9. Train Your Team on Regulatory Requirements

• Ensure developers, testers, product managers, and executives understand FDA regulations relevant to your product.
• Regular training reduces compliance risks and fosters a culture of quality.

10. Engage the FDA Early and Often

• Use the FDA’s Pre-Submission Programme (Pre-Sub) to get feedback on your product and regulatory strategy before a formal submission.
• Early interaction can identify potential issues and save time later.

Following these steps not only helps with FDA approval but also improves overall software quality, reduces risk, and builds trust with users and regulators alike.

What Common Mistakes Should Developers Avoid During FDA Approval?

Avoiding these common pitfalls can save time, money, and frustration during the FDA approval process:

• Many developers assume their software is “just an app” and overlook the need for FDA compliance. This leads to missed requirements and delays.
• Incomplete design history files, missing test reports, or unclear risk management records can cause FDA reviewers to reject your submission.
• Failing to identify or properly mitigate risks to patient safety can be a major red flag.
• Skipping thorough testing or lacking proper validation evidence weakens your case for safety and effectiveness.
• Incorrectly assessing the risk class can result in submitting the wrong approval type, causing delays or rejection.
• The FDA expects plans for monitoring your software once it’s in use. Ignoring this can lead to compliance issues down the line.
• Waiting too long to consult the FDA or regulatory experts can cause missed deadlines and costly rework.

How Can Ailoitte Help with FDA Compliance Software?

Ailoitte offers specialized expertise and customized solutions to guide healthcare software developers through the complex FDA approval process. Here’s how Ailoitte can support your compliance journey:

1. Regulatory Consulting and Strategy

Our experts help you classify your software correctly and design an FDA submission strategy that fits your product’s risk level and intended use. This reduces costly errors and speeds up approvals.

2. End-to-End Quality Management Support

We assist in implementing and maintaining FDA-compliant Quality Management Systems (QMS) aligned with 21 CFR Part 820, ensuring your processes are audit-ready and efficient.

3. Documentation and Validation Services

From preparing detailed Design History Files (DHF) to risk management files and software validation protocols, Ailoitte helps create comprehensive, FDA-ready documentation tailored to your product.

4. Training and Capacity Building

We offer customised training programmes to ensure your development and regulatory teams fully understand FDA requirements and best practices for compliance.

5. Technology Integration and Tools

Ailoitte supports integrating the right software tools for development tracking, risk management, and validation, improving traceability and compliance throughout your SDLC.

Conclusion

Developers who build compliance into their software from the start, maintain rigorous documentation, manage risks effectively, and engage with the FDA early increase their chances of a smooth approval journey. Post-approval, continuous vigilance through maintenance, updates, and post-market surveillance ensures ongoing safety and regulatory adherence. 
Leveraging expert resources, quality management tools, and trusted partners like Ailoitte can further simplify compliance and accelerate your product’s time to market. With the right strategy and support, you can deliver innovative healthcare software that meets regulatory standards and improves patient outcomes.

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