Skip to content

FDA Cybersecurity For Medical Devices: Guidance, Requirements & Vulnerabilities (2023)

FDA Cybersecurity Guidance

FDA cybersecurity guidance is crucial to help make sure that medical devices need to be secure. That’s why there are particular guidelines for medical devices.

Here we clarify what the FDA cybersecurity guidelines are and offer guidance for medical devices.

Are you belonging to a company or business developing a wireless, networked, or interconnected medical device in the United States? If so, you can expect extreme regulatory scrutiny from the US Food & Drug Administration (FDA).

The FDA pays distinct attention to cybersecurity vulnerabilities in medical devices, & has developed cybersecurity control requirements for wireless, network, & similar technologies.

Manufacturers should take additional measures to make sure the cyber security of their devices throughout their lifespan. In this article, we address your major questions about US regulatory needs for wireless medical devices, including:

  • What is compulsory in an FDA 510(k)?
  • What is obligatory in an FDA Premarket Approval (PMA)?
  • What post-market risk management measures does the agency acclaim?
  • What are the components of an amenable cybersecurity framework?

The U.S. Food and Drug Administration issued draft guidance this past week with regard to medical device cyber security.

The draft guidance, “Cybersecurity in Medical Devices: Quality System Concerns and Content of Premarket Submissions,” seems to emphasize the significance of protecting medical devices throughout a good’s life cycle.

The direction would replace one published by the agency in 2018. In the same year, the agency issued a draft of its newest FDA Cybersecurity guidelines.

The guidelines support developers make sure that their medical devices are safe and protected. FDA Cybersecurity guidance also helps devices meet their clearance needs.

The FDA Cybersecurity Guidelines For Medical Devices

• Offer credentials related to design controls. Especially, documentation on project validation, software validation, & threat analysis.

• Make sure that all incoming data is not adapted in transit or at rest. And, that it is acquiescent with the specifications.

• Use industry-accepted top practices. These maintain and confirm the reliability of code while it’s executed by the device.

• Design the medicinal device to sense and respond to Cybersecurity risks. This comprises cybersecurity updates & patches. It also includes reserve workarounds.

• Apply medical device features that guard acute functionality and data. Even when the device’s Cybersecurity is compromised.

Establishing an operative Cybersecurity process can be hard. Consult the FDA’s medical device Cybersecurity fact sheet, too.

What are the FDA Cybersecurity Requirements?

Complying with guidelines is simply one aspect of safe medical device development. There are numerous practices that support Cybersecurity. The following is the most appropriate for medical device Cybersecurity.

FDA Cybersecurity Guidance: 5 Phases of a Secure Development Lifecycle

The secure development lifecycle (SDL) is a software development procedure. SDL reduces software repair costs and boosts software safety.

Here are the five phases of a standard SDL:

1. Requirements

In the Requirements Phase, safety finest practices need to incorporate into the product. These practices could comprise industry standards, coding standards, or important data.

2. Design

The Design Phase frequently involves threat modeling. This scans how a feature or system could be affected by cyber threats. Based upon all of those possible threats, solutions are then incorporated into the design.

3. Implementation

The Implementation Phase merely involves writing the source code. Frequently secure coding guidelines — such as MISRA & CERT — are used to help describe what is expected of the code. And using SAST tools helps recognize potential susceptibilities in the source code.

4. Test

The Test Phase involves:

5. Release/Response

The Release/Response Phase merely involves the device being released. Some problems are addressed as succinctly and competently as possible.

General Principles

This segment provides general principles for device Cybersecurity applicable to devise manufacturers.

These values, found throughout this guidance document, are significant to the development of device Cybersecurity and, when followed, are expected to have an optimistic impact on patient security.

These general principles include:

• Cybersecurity is Part of Device Safety & the Quality System Regulations

• Designing for Safety

• Transparency in Cybersecurity

• Submission Documentation

Including Cybersecurity into Quality System Regulations to Increase Safety

With innovative guidance, the FDA seeks to make sure that the next generation of medicinal devices will be far safer and protected throughout the whole device life cycle, from premarket & throughout the whole useful life, starting from the earliest stages of design (shift-left) to post-production (shift-right).

With the planned guidance, the FDA is doubling down on its efforts to include Cybersecurity into quality regulations to address the difficulty of modern devices & today’s evolving threat landscape.

FDA Cybersecurity Medical Devices

In comparing the 2022 Cybersecurity draft direction with the earlier version from 2018, there are numerous noteworthy changes. One important change was the removal of the two-tier risk framework in the 2018 draft direction.

Earlier, medical devices — nonetheless of their risk class — were divided into two tiers. Tier 1 was reserved for medical devices that posed an advanced Cybersecurity risk because they met two criteria:

The accomplishment of connecting to a different medical or nonmedical product, to a network, or to the internet, and a cybersecurity event affecting the device could openly result in patient harm to several patients.

Examples of Tier 1 devices, under the 2018 draft direction, comprised pacemakers, dialysis devices, infusion & insulin pumps, usable cardioverter defibrillators, left ventricular help devices, brain stimulators & neurostimulators.

Tier 2 accounted for all other medicinal devices and was categorized as having a standard Cybersecurity risk.

In the existing draft guidance, the FDA says that the applicable scope is all devices that have software, including firmware, or programmable logic.

In addition to software as a medical device, regardless of whether they are network-enabled or include other associated capabilities.

One more change that is noteworthy is the concept of a software bill of resources, which is a list of software components, including but not limited to profitable, open-source, off-the-shelf, & custom software components.

The software bill of materials is fundamentally a tool to help companies assess potential Cybersecurity risks during the course of the supply chain.

The FDA commends companies to contain software bill of materials certification in their premarket submissions & in the labeling.

In the 2018 draft direction, the FDA had introduced a parallel concept of a Cybersecurity bill of materials that was projected to be a complete list of all commercial, open-source, and off-the-shelf software.

In addition to hardware components that are or could become vulnerable to vulnerabilities.

Equally, the Cybersecurity bill of materials was meant to support companies develop and implement suitable controls.

Given the media attention & the volume of ink that has been spilled on the topic of Cybersecurity over the years, it might come as a surprise that the FDA’s public implementation record on Cybersecurity issues has been factually sparse.

As of the date of this publication, there has only been a trickle of FDA warning letters that specifically discuss Cybersecurity issues.

But the comparatively low numbers might be explained in part by the fact that there are no express federal constitutional needs in the Federal Food, Drug, & Cosmetic Act that needs medical device makers to adopt Cybersecurity requirements.

Consequently, the FDA has been using guidance to signal to the business that Cybersecurity issues will be considered throughout the premarket submission process and the business may start to see more inspectional observations relating to Cybersecurity-related processes & controls.

Cybersecurity Vulnerabilities in Medical Devices

Cybersecurity vulnerabilities in medicinal devices clearly can pose very serious risks. As devices evolve to be more consistent, these risks might multiply: vulnerabilities may affect numerous devices using similar software or components.

Following the public’s input, in the fresh Cybersecurity Best Practices, the FDA has refined its guidance on the factors that device business members & other stakeholders must consider when designing communications about Cybersecurity vulnerabilities. These factors comprise:

  • The interpretability of secure communications. To help make sure their value, communications should be:
  • Timely, or delivered as fast as possible after a practical assessment of the nature of the vulnerability, what goods were impacted, strictness, & mitigating actions;
  • Relevant, by communicating risks significant to the patient;
  • Readable, clear, and modest, remember that the target audience may not be aware of business terminology or jargon (i.e., “filtering damaging websites” in its place of “blacklist”; “data breach” instead of “data leakage”); and
  • Understandable by linguistically different audiences.
  • Discussing risks & benefits, including communicating when the possibility of Cybersecurity exploitation remains unidentified, & considering risks connected with mitigation.

Vulnerability to Denial of Service Attacks

Different medical devices utilize wireless networks to exchange information & data, which can generate serious problems in achieving the security goals of reliability, confidentiality, and accessibility.

Wireless networks are basically radio signals conveyed between devices, which have been encoded to store & carry data. It is an EM wave that transmits digital data and is susceptible to interference by other EM waves. This presents two main security challenges:

1. Jamming these signals is very easy and can prevent these devices from connecting to one another.

2. It can be very hard to track the source of the overcrowding or stop the jamming.

These kinds of attacks are recognized as denial of service attacks. These attacks affect the accessibility of information and can obstruct the presentation of medical devices.

If a medical device is susceptible to denial of service attacks, it can cause several serious security issues.

Vulnerability to Stack-based Buffer Overflows

Stack-based buffer overflow attacks are used by the attackers to tenuously take over the code execution of a procedure. Buffers mention a system’s memory storage regions that hold the data provisionally while it is being moved.

A buffer overflow takes place when the volume of data exceeds the memory buffer’s storage capability. So, the program trying to write the data overwrites contiguous memory locations.

Kevin James

Kevin James

I'm Kevin James, and I'm passionate about writing on Security and cybersecurity topics. Here, I'd like to share a bit more about myself. I hold a Bachelor of Science in Cybersecurity from Utica College, New York, which has been the foundation of my career in cybersecurity. As a writer, I have the privilege of sharing my insights and knowledge on a wide range of cybersecurity topics. You'll find my articles here at, covering the latest trends, threats, and solutions in the field.