Understanding FDA Regulation and Cybersecurity Guidance for Software-Enabled Medical Devices
- Kristina Romanenko
- May 21
- 12 min read
Updated: Jun 10
The U.S. Food and Drug Administration (FDA) is a federal agency under the Department of Health and Human Services (HHS) that oversees the development, approval, and regulation of health-related products across the United States. The FDA sets and enforces standards to ensure products meet legal and scientific requirements before and after they reach the market.
🎯 Before diving deeper, get our free FDA Cybersecurity Compliance Self-Assessment Checklist to evaluate your readiness and align your development process with FDA expectations.
📌 FDA Mission:
To protect public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of food, cosmetics, and radiation-emitting products. [1]
❗The FDA regulates medical devices - not organizations. While manufacturers are required to implement a quality management system, FDA oversight focuses on the safety and effectiveness of the device itself, rather than the broader cybersecurity posture or enterprise-level practices of the organization.
Main Functions of the FDA:
Evaluate and approve medical and drug products before market entry
Inspect manufacturing facilities
Monitor postmarket safety
Issue recalls, safety alerts, and import bans
Enforce labeling and advertising standards
Support innovation through regulatory science and industry guidance
Is Your Product A Medical Device?
Before diving into cybersecurity or regulatory pathways, it's essential to determine whether your product meets the FDA’s legal definition of a medical device. This definition is the foundation for whether FDA regulation applies - and it includes more than just hardware.
Under Section 201(h) of the Federal Food, Drug, and Cosmetic (FD&C) Act, a medical device is defined as:
… an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article (which may be a software), including any component, part, or accessory, which is-- (1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. [2]
❓ Ask Yourself:
Does your product diagnose a medical condition?
Does your product treat a medical condition?
Does your product monitor a disease or its progression?
If your answer is “yes” to any of these questions, your product is a medical device under FDA regulation - whether it’s hardware, software, or a combination of both. [3]
⚠️ Exceptions: Low-Risk Wellness Products
FDA does not intend to enforce regulatory requirements on certain low-risk wellness products, even if they technically meet the definition of a "device" under the law:
The product must be intended only to promote a healthy lifestyle and not for diagnosis, cure, treatment, or prevention of disease.
The product must pose minimal safety risk. [4]
Classify Your Medical Device
Once you’ve determined that your product qualifies as a medical device under the FDA definition, the next critical step is to identify its classification. Classification determines the regulatory pathway you’ll need to follow (such as 510(k), De Novo, or PMA), the level of documentation required, and whether any exemptions or special controls apply.
To determine your device's classification, you need to locate its classification regulation number in the FDA’s system. There are two primary ways to do this:
There are two methods for accomplishing this:
Go directly to the classification database and search for a part of the device name, or,
If you know your device’s medical specialty (e.g., cardiology, radiology), go directly to the listing for the device panel and identify your device and the corresponding classification.
If you're unsure how your product should be classified or want formal written feedback from the FDA, you can submit a 513(g) Request for Information to receive information on:
Whether your product is considered a medical device
Which classification applies
What premarket pathway you’ll need to follow
💡 A user fee applies to 513(g) submissions (discounted for small businesses).
You can also contact the Division of Industry and Consumer Education (DICE) for non-binding assistance to help you understand FDA regulations, including device classification [5]. Alongside device classification, manufacturers must also consider the requirements outlined in FDA guidance on cybersecurity, which applies to any software-based or connected medical device.
Premarket Submission Pathways
Once you've determined that your product is a medical device and understand its classification (Class I, II, or III), the next step is selecting the appropriate premarket submission pathway. This is how you formally seek the FDA’s permission to bring your product to market.
The FDA offers different submission pathways based on a device’s risk level, novelty, and whether a predicate device (i.e., an existing, legally marketed equivalent) is available. Below are the three most commonly used pathways for medical device authorization:
Premarket Notification 510(k) - a Class I, II, and III device intended for human use, for which a Premarket Approval application (PMA) is not required. Most Class I devices and some Class II devices are exempt from the Premarket Notification 510(k) submission.
Your product qualifies if:
Your device is moderate-risk (Class II).
It is substantially equivalent to an existing device already cleared by the FDA (predicate)
⏱ Timeline: ~90 days
💵 Fee (FY 2024): ~$22,000 (or ~$5,500 for small businesses)
📜 FDA Issues: 510(k) Clearance Letter [6]
De Novo Classification Request - provides a marketing pathway to classify novel medical devices if:
Your device is low to moderate risk (Class I or II).
It has no predicate, so 510(k) doesn’t apply.
It is novel but not high-risk.
⏱ Timeline: ~150–180 days
💵 Fee: ~$112,000 (small biz: ~$28,000)
📜 FDA Issues: New device classification (which becomes a future predicate) [7]
Premarket Approval (PMA) - the process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.
Your product qualifies if:
Your device is high-risk (Class III).
It supports or sustains life (e.g., implantable defibrillator, heart valve).
No equivalent device exists, or the risk is too great for lower pathways.
⏱ Timeline: 6 months to 2+ years
💵 Fee: ~$483,000 (small biz: ~$121,000)
📜 FDA Issues: Approval Letter [8]
Most Class I and some Class II devices are formally exempt from the 510(k) premarket notification requirement. [9] However, they are still considered medical devices and must comply with general FDA requirements, including labeling, quality system controls, and, where applicable, cybersecurity and postmarket risk management.
How FDA Guidance on Cybersecurity Applies to Medical Devices
Regardless of the submission pathway, all FDA-regulated medical devices must demonstrate their safety, effectiveness, and quality. For devices that incorporate software, firmware, or network connectivity, this also includes proactively addressing cybersecurity risks that could impact functionality or patient safety.
Cybersecurity is not limited to high-risk or novel devices - it applies to any device that meets the definition of a "cyber device" under Section 524B of the FD&C Act. This includes devices that:
Contain software,
Connect to a network (such as the internet or hospital systems), and
Could be susceptible to cybersecurity vulnerabilities.
The legal foundation for FDA cybersecurity expectations includes:
Section 524B of the FD&C Act - the first statute to mandate cybersecurity in premarket submissions. It requires "cyber devices" to include a cybersecurity plan, a Software Bill of Materials (SBOM), and secure update capabilities. [10]
21 CFR Part 820 - the Quality System Regulation (QSR), which mandates design controls. Devices with digital interfaces must integrate cybersecurity into their design and development processes. [11]
Cybersecurity in Medical Devices: Premarket Submission Guidance — while not law, this document outlines the FDA’s expectations for cybersecurity documentation in premarket submissions. It introduces concepts like threat modeling, security risk management, and secure product development frameworks (SPDF). [12]
Postmarket Cybersecurity Guidance - establishes expectations for monitoring and mitigating cybersecurity risks after a device reaches the market, including vulnerability detection, coordinated disclosure, and timely patching. [13]
In short, if your device has the potential to be compromised by cybersecurity threats, the FDA expects you to manage those risks across the entire product lifecycle - from design to postmarket use - regardless of the regulatory pathway.
FDA’s Core Cybersecurity Expectations
When evaluating medical devices, the FDA looks for evidence that cybersecurity is proactively integrated across the entire product lifecycle. These five expectations serve as the foundation for a strong submission and ongoing postmarket compliance:
Demonstrate a “reasonable assurance of cybersecurity”: The FDA expects manufacturers to confidently show that cybersecurity risks are identified, documented, and appropriately mitigated.
Secure the entire ecosystem: The FDA expects you to assess how your device interacts with non-medical systems - like hospital networks, third-party apps, or cloud services—that could introduce vulnerabilities.
Embed security into system architecture: The FDA expects cybersecurity to be an integral part of the design process from the start, with security controls tied into software architecture, development, and implementation.
Stay Ahead of Emerging Threats: The FDA expects manufacturers to actively track and address new vulnerabilities as they arise, demonstrating that they’re maintaining product security in the field.
Design for secure and timely updates: The FDA expects your device to support patching and updates - even post-deployment - through mechanisms that are secure, verifiable, and compatible with supported platforms.
Key Cybersecurity Elements for Premarket Submission
When submitting a medical device for FDA review - whether through 510(k), De Novo, or PMA - manufacturers of software-based or connected devices must include cybersecurity documentation as part of the submission package. The level of detail expected is outlined in the FDA’s 2023 guidance, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.
Key cybersecurity documentation to include in your premarket submission:
Security Architecture Views - ****visual and descriptive representations of the system architecture, including security boundaries, trust zones, data flow diagrams, update pathways, and attack surface delineations.
Threat Model - a structured analysis of potential attack vectors, assets to protect, known threats, misuse cases, and the effectiveness of existing controls.
Safety & Security Assessment of Vulnerabilities - integrated review of software vulnerabilities that may impact device functionality, safety, or performance, especially in relation to patient harm.
Cybersecurity Risk Assessment - a systematic evaluation of risks distinct from safety hazards, including likelihood and impact of exploitation, risk acceptance rationale, and residual risk assessments.
Cybersecurity Controls Documentation - a detailed description of implemented technical and procedural controls, such as authentication, encryption, access control, logging, and patching strategies.
Cybersecurity Management Plan - your strategy for monitoring threats, issuing patches, and disclosing vulnerabilities throughout the device lifecycle.
Software Bill of Materials (SBOM) - a detailed inventory of all third-party, open-source, and proprietary components, including support status and known vulnerabilities.
Assessment of Unresolved Anomalies – a list of known bugs present in the release version of the software, including an assessment of their potential impact on safety and performance, justification for not resolving them premarket, and any existing mitigations.
Cybersecurity Testing Reports - results of penetration testing, vulnerability scanning, fuzz testing, and static/dynamic code analysis.
Cybersecurity Metrics - quantitative indicators used to measure the effectiveness of the cybersecurity program, such as patch latency, vulnerability response time, or incident trends.
Security Risk Management Report - a cumulative record tying all identified risks, mitigations, and residual risks into a structured report that aligns with ISO 14971 and FDA expectations.
Cybersecurity Labeling - instructions for end users on safe configuration and maintenance of the device.
This documentation supports the FDA’s expectations that cybersecurity is integrated into the design control process under 21 CFR Part 820, and must be aligned with the Secure Product Development Framework (SPDF) principles.
It should also be consistent with the FDA’s guidance on Content of Premarket Submissions for Device Software Functions, which outlines best practices for documenting software design, development, and validation in regulated devices. [14]
Managing Cybersecurity after FDA Approval
Cybersecurity responsibilities don’t end at market approval. Once a device is in use, manufacturers are expected to actively monitor and manage ongoing risks. The FDA’s Postmarket Management of Cybersecurity in Medical Devices (2016) outlines the actions manufacturers must take to support the continued safety and effectiveness of cyber devices.
Postmarket cybersecurity expectations include:
Continuous Monitoring - stay alert to new threats, vulnerabilities, and emerging risks. Track public advisories, internal testing results, and industry trends to keep the device secure in a changing environment.
Postmarket Risk Assessment - evaluate whether discovered vulnerabilities introduce uncontrolled risk, and take action accordingly.
Incident Management - document and respond promptly to security events. Manufacturers should communicate with stakeholders, resolve issues quickly, and use each incident as an opportunity to improve defenses.
Software Maintenance - issue timely patches and updates. Devices must support secure update mechanisms, and manufacturers should ensure updates are delivered, verified, and successfully installed across all deployments.
Security Metrics - define and track meaningful indicators of cybersecurity performance, such as time to detect vulnerabilities, patch deployment timelines, incident response times, and control effectiveness. Use this data to guide ongoing improvements and demonstrate compliance.
Customer Communication - notify users of confirmed vulnerabilities, recommended actions, and available updates.
These postmarket responsibilities apply to all marketed cyber devices, regardless of the premarket submission type, and reflect the FDA’s lifecycle-based approach to cybersecurity risk management.
Common Cybersecurity Pitfalls and How to Avoid Them
When preparing a medical device submission for FDA review, overlooking key cybersecurity expectations can lead to delays, rejections, or even a complete regulatory hold. Below are some of the most common mistakes manufacturers make - and how to avoid them.
1️⃣ Skipping Penetration or Fuzz Testing Due to “Low Risk” Scores
The Risk: Some teams skip penetration or fuzz testing after assigning low scores in their cybersecurity risk assessment, assuming it's unnecessary. However, the FDA expects at least minimal evidence of vulnerability testing, regardless of the initial risk rating. Submissions without it risk being paused or rejected - adding months to your timeline.
How to Avoid It: Conduct a baseline level of pentesting and fuzz testing. Even if your assessment deems the risk low, testing can reveal overlooked vulnerabilities and reassure the FDA of your due diligence.
2️⃣ Dismissing Threats Too Quickly
The Risk: Manufacturers may downplay or exclude threats they perceive as unlikely or difficult to exploit. This undermines the purpose of threat modeling. The FDA may identify threats you’ve excluded and challenge your submission, requiring resubmission or more analysis.
How to Avoid It: Document all potential threats first, then justify why some may be deprioritized. Comprehensive documentation and rationale are critical—even for threats with low scores.
3️⃣ Using Probabilistic Risk Scoring Methods
The Risk: Some teams use probabilistic methods—like estimating likelihood—to assess cybersecurity risks, but the FDA explicitly discourages this approach, as it’s often unreliable in the face of fast-changing threat environments.
How to Avoid It: Use deterministic scoring methods like CVSS (Common Vulnerability Scoring System for Medical Devices) and provide a clear methodology for both identifying and assessing threats.
4️⃣ Using Unsupported Operating Systems
The Risk: Designing updates to support legacy operating systems - even those no longer maintained, like Windows 8 - can halt your submission, as the FDA will not review or approve devices that rely on unsupported software.
How to Avoid It: Ensure your device and update mechanisms are based on currently supported platforms. Avoid dependencies that are at or near end-of-life.
5️⃣ Separating Software and Security Architectures
The Risk: Treating security architecture as an afterthought rather than integrating it into the overall system design can lead to fragmented functionality, increased complexity, and a wider attack surface - making your device harder to secure, justify to the FDA, and maintain efficiently.
How to Avoid It: Adopt a unified architecture approach. Isolate medical device functionality into secure, well-defined modules. This simplifies validation, reduces security risks, and limits the regulatory impact of future changes.
6️⃣ Poor Traceability of Cybersecurity Artifacts
The Risk: Lacking clear traceability between risk analysis, design specifications, testing requirements, and results can jeopardize your submission, as FDA reviewers must be able to follow each identified hazard through to its mitigation and verification.
How to Avoid It: Build a strong traceability matrix. Ensure hazards identified in risk analysis are clearly connected to design controls, test cases, and documented results. This is especially critical for AI/ML-based devices, where traceability gaps are a common cause of FDA AI Holds.
Cybersecurity is not just about technical defenses - it’s about showing the FDA that your entire process is robust, well-documented, and lifecycle-aware. Avoiding these pitfalls can dramatically improve your chances of a smooth, timely submission.
Getting Started with FDA Cybersecurity Readiness
The FDA now expects manufacturers to take a lifecycle approach to cybersecurity - from premarket planning to postmarket monitoring - with clear documentation, proactive risk management, and secure engineering practices embedded throughout.
If you're preparing to bring a software-based or connected medical device to market, here are the critical first steps to help you start strong:
Know Your Requirements: Identify which FDA regulations and guidance documents apply to your product early to avoid missteps and delays.
Involve the Right People: Ensure your team includes regulatory and cybersecurity experts - in-house or external - who understand the FDA process.
Start Documentation Early: Begin tracking software and cybersecurity decisions from day one. Your submission will require extensive evidence.
Treat Cybersecurity as a Design Input: Build security into your architecture, risk assessments, and development lifecycle - not as an afterthought.
Plan Your Pre-Submission Meeting: Use the Pre-Sub to align your testing and documentation plans with FDA expectations before moving forward.
To Help You Evaluate Your Readiness:
The self-assessment maps FDA cybersecurity expectations to practical development and documentation activities. Whether you’re preparing a new submission or reviewing your current approach, this tool can help you assess where you stand, spot gaps early, and ensure your team is aligned with FDA requirements before entering the review process.
About The Author
Kristina Romanenko is an Information Security Account Manager at Sekurno and a certified ISO/IEC 27001 Implementer (PECB). With over 6 years of experience in IT and cybersecurity, Kristina helps organizations confidently navigate regulatory frameworks such as GDPR, CCPA, HIPAA, and ISO 27001. She supports clients in meeting compliance requirements, reducing risk exposure, and building long-term trust with customers and partners.
Sekurno is a globally recognised cybersecurity firm specializing in Penetration Testing, Application Security and Compliance. At Sekurno, we dedicate all our efforts to reducing risks to the highest extent, ensuring high-risk industries like HealthTech and FinTech stand resilient against any threat.
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