Penetration Testing for Medical Devices: A Guide for FDA Submissions

Cybersecurity has become an essential component of FDA submissions for medical devices with cybersecurity risks. Manufacturers are expected to demonstrate not only that security controls have been implemented, but also that those controls perform as intended under realistic conditions. As a result, penetration testing for medical devices has become an important part of preparing submission-ready cybersecurity documentation.

Penetration testing provides objective evidence that security controls can withstand realistic attack scenarios. When combined with threat modeling, cybersecurity risk assessments, and supporting documentation, testing helps manufacturers present a more complete cybersecurity package during FDA review.

Why Penetration Testing Matters During FDA Submission Preparation

Cybersecurity is now a core component of FDA review for connected medical devices. Reviewers expect manufacturers to demonstrate that cybersecurity risks have been identified, evaluated, and appropriately mitigated throughout the product lifecycle. Penetration testing helps support these expectations by validating that implemented security controls perform as intended.

Rather than relying solely on design documentation or theoretical analyses, penetration testing evaluates how a device responds to realistic attack scenarios. The results provide objective evidence that complements cybersecurity risk assessments and strengthens the overall submission package.

How Penetration Testing Supports Submission Readiness

Effective penetration testing helps manufacturers:

• Validate authentication and access controls
• Evaluate network and communication security
• Identify vulnerabilities before submission
• Confirm the effectiveness of implemented security controls
• Support cybersecurity risk assessments with objective evidence

Testing should not be treated as a standalone activity. FDA reviewers evaluate penetration testing alongside threat modeling, vulnerability management, software architecture, and other cybersecurity documentation. Organizations preparing cybersecurity documentation for FDA submissions⁠ often incorporate testing results directly into their broader submission package, helping reviewers understand how identified risks have been evaluated and addressed.

Reducing Review Delays

Incomplete cybersecurity evidence can result in Additional Information (AI) requests during FDA review. Documentation gaps such as limited testing scope, missing remediation records, or weak connections between testing results and risk assessments can delay the review process.

Planning penetration testing early and documenting the results clearly helps strengthen submission readiness while reducing the likelihood of follow-up questions.

When Penetration Testing Should Be Performed During Device Development

One of the most common misconceptions is that penetration testing should occur only after software development is complete. In practice, testing is most effective when integrated throughout the development lifecycle rather than performed immediately before submission.

Conducting penetration testing during development allows manufacturers to identify vulnerabilities earlier, implement corrective actions before release, and reduce remediation costs.

Integrating Testing Into the Product Lifecycle

Cybersecurity testing should support multiple stages of development, including software design, verification, validation, and final submission preparation. A phased approach helps ensure security controls remain effective as the device evolves.

Many organizations perform testing during:

• Software development milestones
• Design verification activities
• System validation
• Final pre-submission reviews

Testing at multiple stages allows development teams to resolve vulnerabilities before they become more difficult and expensive to address.

Aligning Testing With Regulatory Milestones

Cybersecurity testing should also align with major regulatory activities. Before submission, manufacturers should confirm that penetration testing reflects the final software configuration and any significant design changes made during development.

Organizations developing connected products often integrate testing into broader medical device cybersecurity compliance⁠ efforts to maintain consistency between software development, risk management, and regulatory documentation.

Manufacturers preparing FDA 510(k) submission support⁠ also benefit from reviewing cybersecurity evidence early, giving quality and regulatory teams time to address documentation gaps before submission.

Key Areas FDA Reviewers Expect Penetration Testing to Address

The scope of penetration testing should reflect the device's architecture, intended use, and cybersecurity risk assessment. Rather than testing every possible scenario, manufacturers should focus on the systems and functions that present the greatest cybersecurity risk.

Authentication and Access Controls

FDA recommends that manufacturers provide evidence showing how access to device functions and sensitive information is restricted to authorized users. Penetration testing should evaluate authentication methods, user privilege management, session controls, and protections against unauthorized access or privilege escalation.

Communications and Connected Systems

Connected medical devices often communicate through wireless technologies, APIs, cloud services, or remote interfaces. Testing should evaluate these communication pathways to confirm they are protected against unauthorized access, data interception, and other common attack methods.

Data Protection and Software Components

Penetration testing should also assess how the device protects sensitive data during storage and transmission. Depending on the device, testing may include:

• Encryption of stored and transmitted data
• Software update mechanisms
• Third-party software components
• APIs and cloud-connected services
• Software Bill of Materials (SBOM) considerations
• Vulnerability management processes

The testing scope should remain aligned with the manufacturer's threat model and cybersecurity risk assessment, so reviewers can clearly understand why specific areas were evaluated.

Organizations performing cybersecurity testing for medical devices⁠ often define the testing scope using identified threats, system architecture, and known cybersecurity risks to ensure the assessment supports overall submission readiness.

What FDA Reviewers Look for in Penetration Testing Reports

Performing penetration testing is only one part of the submission process. Manufacturers should also provide documentation that clearly explains how testing was performed, what vulnerabilities were identified, and how those findings were addressed.

Well-organized reports make it easier for FDA reviewers to evaluate cybersecurity evidence alongside the rest of the submission.

Elements of a Strong Testing Report

Penetration testing reports should generally include:

• The testing scope and systems evaluated
• Testing methodology and objectives
• The software or device configuration that was tested
• Identified vulnerabilities and severity ratings
• Remediation activities performed
• Residual risk evaluations
• Traceability to the cybersecurity risk assessment

This information helps reviewers understand both the testing process and the manufacturer's approach to managing cybersecurity risk.

Supporting the Overall Submission

Penetration testing reports should not stand alone. Instead, they should align with threat modeling, cybersecurity risk assessments, software documentation, and vulnerability management activities included elsewhere in the submission.

Clear documentation allows reviewers to trace identified vulnerabilities through remediation and confirm that remaining risks have been evaluated appropriately. Manufacturers that integrate penetration testing into their medical device regulatory compliance⁠ activities often produce more consistent cybersecurity documentation and are better prepared to respond to regulatory questions.

As organizations expand into connected products and digital health technologies, maintaining documentation that supports broader healthtech regulatory compliance⁠ initiatives can also improve long-term submission readiness.

Common Penetration Testing Gaps That Create Submission Delays

Penetration testing provides valuable evidence during FDA review, but the results are only as useful as the documentation that supports them. Even well-executed testing can generate Additional Information (AI) requests if the submission does not clearly explain the testing process or connect the results to the broader cybersecurity strategy.

Some of the most common issues include:

• Testing performed too late. Conducting penetration testing only at the end of development leaves little time to remediate identified vulnerabilities before submission.
• Incomplete testing scope. Critical system components, communication interfaces, or third-party software dependencies may not be evaluated.
• Missing remediation documentation. Reports should explain how identified vulnerabilities were addressed and verified.
• Weak traceability. Testing results should align with threat modeling and cybersecurity risk assessments.
• Inconsistent documentation. Differences between testing reports, risk assessments, and other submission materials can create unnecessary reviewer questions.

Addressing these gaps before submission helps strengthen the overall cybersecurity package and reduces the likelihood of delays during FDA review.

How Penetration Testing Fits Into a Complete Cybersecurity Submission Strategy

Penetration testing is an important component of FDA cybersecurity documentation, but it should not be viewed as a standalone activity. Reviewers evaluate cybersecurity as a complete body of evidence that demonstrates how risks have been identified, assessed, and managed throughout the product lifecycle.

A comprehensive cybersecurity submission typically includes:

• Threat modeling
• Cybersecurity risk assessments
• Vulnerability management activities
• Software Bills of Materials (SBOMs)
• Penetration testing results
• Supporting design and software documentation

Together, these activities provide reviewers with a clearer understanding of the device's cybersecurity posture and the manufacturer's overall risk management strategy.

Preparing for FDA Review: Building a Submission-Ready Penetration Testing Package

Preparing for FDA review begins well before submission. Manufacturers should confirm that penetration testing reflects the final software configuration, that identified vulnerabilities have been appropriately remediated, and that supporting documentation is complete and consistent.

Before submission, organizations should:

• Validate that the testing scope aligns with identified cybersecurity risks.
• Document remediation activities and residual risk evaluations.
• Maintain traceability between testing findings, implemented controls, and cybersecurity risk assessments.
• Organize supporting evidence so it is easy for reviewers to locate and evaluate.

Quality Commercial Consultants helps manufacturers prepare submission-ready cybersecurity documentation that supports efficient FDA review. Our collaborative approach helps manufacturers build practical, reviewer-focused documentation that supports FDA submissions. Learn more about how we work⁠ and how we help organizations prepare for evolving regulatory expectations.

If you're looking for additional information about regulatory requirements, visit our medical device regulatory FAQs⁠ for answers to common questions about FDA submissions, cybersecurity, and compliance. Or, contact us⁠ today to learn how Quality Commercial Consultants can help you build a more complete, submission-ready cybersecurity package.