The U.S. Food and Drug Administration (FDA) has been actively working to address cybersecurity concerns related to medical devices. On March 29, 2023, FDA published a much-anticipated cybersecurity final guidance regarding cybersecurity requirements for medical device pre-market submissions. Medical devices, like many other modern technologies, are susceptible to cybersecurity vulnerabilities that could potentially compromise patient safety and data security. In response, the FDA has issued a final guidance outlining requirements for manufacturers to address cybersecurity risks in their pre-market regulatory submissions (e.g., 510(k)s, PMAs) for their “cyber devices.” A “cyber device” is a device that “(1) includes software validated, installed, or authorized by the sponsor as a device or in a device, (2) has the ability to connect to the internet, and (3) contains any such technological characteristics validated, installed, or authorized by the sponsor that could be vulnerable to the cybersecurity threats”. Although FDA has the authority to require manufacturers to address cybersecurity risks in new pre-market submissions for cyber devices beginning March 29, 2023, FDA has stated they intend to exercise enforcement discretion until October 1, 2023. These new requirements apply only to new pre-market submissions and not to devices already on market (unless a change is made to a marketed device that warrants a new submission).
When seeking legal services in this domain, it is important to find a law firm with comprehensive expertise in medical device regulation, cybersecurity, and medical applications, that can provide comprehensive assistance to medical device companies in achieving compliance with FDA’s cybersecurity requirements. OFW can provide such expertise.
OFW has significant experience in dealing with medical device regulatory issues and understanding various related medical issues. OFW has the necessary expertise to offer FDA regulatory assistance to companies whose new device submissions will require compliance with FDA’s cybersecurity guidance. OFW’s Medical Device Team includes Medical Device Practice Head Stephen D. Terman, JD, Dr. Ed Teitel, MD., JD., MBA, Dr. James Capone, MS, PhD, Joseph Terman, MA in Cyber Security, and Andrew Harrison, JD, MS. Given FDA’s enhanced focus on cybersecurity, OFW can provide valuable services related to cybersecurity to manufacturers seeking to navigate the complex regulatory landscape.
Some of the areas that OFW can assist manufacturers in understanding and complying with related to cybersecurity for medical devices are:
- Preparation of Submissions
OFW can help prepare and review pre-market submissions to ensure that cybersecurity considerations are properly addressed.
- Risk Assessment and Management
OFW can work with manufacturers to conduct comprehensive risk assessments and help develop strategies for managing cybersecurity risks throughout the device’s lifecycle.
- Interaction with FDA
OFW can facilitate communication between manufacturers and the FDA, helping to address any inquiries or concerns.
- Post-Market Considerations
Manufacturers are expected to have processes in place to monitor and address cybersecurity vulnerabilities in devices that are already on the market. Timely updates and patches might be required to address new vulnerabilities. OFW can assist the manufacturer with periodic audits of their quality system to ensure compliance with the requirements.
For additional information, see FDA’s 2014 guidance “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices” and the 2016 guidance “Post-market Management of Cybersecurity in Medical Devices.” Please contact Steve Terman (sterman@ofwlaw.com, 301-758-2000) if you have any questions or interest is discussing FDA cybersecurity issues.
