Updated November 17, 2024
Medical devices have ushered in a new age of healthcare driven by innovation and technology. These additions to the ecosystem of care offer benefits for providers and their patients. However, manufacturers must adapt to regulatory requirements with cybersecurity practices for protecting medical devices.
Adhering to the rules of the Food and Drug Administration (FDA) is critical for the approval of the device and its ongoing use in the market. Going beyond the minimum requirements in developing cybersecurity strategies ensures your device is secure today and into the future.
For a quick reminder, review this checklist for protecting medical devices, with cybersecurity practices for device manufacturers.
Device Manufacturer’s Checklist: Must-Haves for Cybersecurity
The list begins with all the FDA requirements, updated in September 2023. They define many cybersecurity best practices to protect medical devices. In addition, manufacturers should employ protocols that ensure maximum vigilance and visibility.
Define how you will track and address cybersecurity issues that occur post-market.
Your initial premarket submission must include how you will manage cybersecurity risks after device approval and once in use. You’ll need a detailed plan of all efforts to identify and resolve any potential weaknesses. It can include penetration testing, vulnerability assessments, and other proactive cyber-attack initiatives.
Implement internal procedures for sending patches and updates to devices after locating vulnerabilities.
Your organization will need to establish a consistent method for device patches and updates. It should outline how a vulnerability triggers an update and how you’ll send it to devices.
Develop an SBOM and submit it with your FDA filings.
An SBOM is a software bill of materials. It is a formal and standardized list of every software component and its dependencies and metadata. It would include open-source and third-party software, firmware, binaries, cloud resources, and APIs (application program interfaces).
In addition, your SBOM must explain how you will monitor, identify, and address cybersecurity vulnerabilities. The FDA requires testing and protocols in the SBOM that assess risks, entry points, existing controls, and data flows.
Comply with forthcoming yet-to-be-created rules from the FDA.
While you don’t know what the FDA will issue in the future, you can prepare by having an agile, evolving cybersecurity strategy. One central philosophy for being prepared is to be proactive in your cyber best practices.
Some examples are:
- Monitoring endpoints with advanced tools
- Continuously performing pen testing and vulnerability scans and remediating after
- Reviewing your cybersecurity plans regularly for updates
- Adopting the standards the FDA recognizes as best practices: ANSI/AAMI 2700-2-1, ANSI AAMI SW96:2023, and ISO/IEC/IEEE 29119-1
Complete the 510(k) premarket submission SE requirements.
SE (substantial equivalent) was part of the 510(k) before the update and is crucial for approval. You will compare a new device to one that is similar and already approved. A device would be an SE if it has the same intended use and technological characteristics of a predicate. It can also be an SE if the same is true and it doesn’t raise any new safety and effectiveness questions, and the submission demonstrates that it is safe.
Avoid other premarket errors relating to medical device cybersecurity.
The FDA kicks back many 510(k) submissions due to mistakes. The most common include:
- Inadequate descriptions
- Discrepancies
- Usage indication problems
- Incomplete testing
- Non-compliance with standards
- Missing clinical data
Minimize the chance of these invalidating your premarket approval by partnering with a firm that specializes in medical device cybersecurity.
Create and sustain a secure-by-design culture.
Security considerations should be part of any new device product development. Don’t ignore it until the end. You’ll lose time and money. At the launch of your cycle, confer with medical device cybersecurity experts to understand the implications and protect the equipment from the onset.
Get Support for Cybersecurity Best Practices for Protecting Medical Devices
The regulatory and cyber environment for medical devices keeps evolving. It’s hard for manufacturers to keep up. You can get the support you need to meet standards and protect devices with us. We’re experts ready to help. Get in touch to learn more.
