FDA Issues Final Guidance on Cybersecurity in Medical Devices
FDA Issues Final Guidance on Cybersecurity in Medical Devices
The U.S. Food and Drug Administration (FDA) has recently unveiled its comprehensive final guidance titled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. This strategic document is the successor to the guidance previously issued on October 2, 2014. It serves as a robust resource, laying down explicit recommendations concerning medical device cybersecurity considerations, streamlined device design, standardized labeling, and content that should be meticulously detailed in premarket submissions.
The FDA unambiguously elucidates its objective, stating, “These recommendations are intended to promote consistency, facilitate efficient premarket review and help ensure that marketed medical devices are sufficiently resilient to cybersecurity threats”
- Connected Device Protocols: Emphasis has been placed on the rigorous testing and validation of interconnected devices to ensure they are safeguarded against potential breaches, especially those that might imperil multiple devices.
- Transparent Labeling: The FDA provides definitive labeling recommendations for devices that are inherently susceptible to cybersecurity risks.
- Cybersecurity Management Plans: A significant recommendation encourages companies to meticulously develop and implement comprehensive cybersecurity management plans. These plans should clearly articulate methodologies to identify, address, and communicate postmarket vulnerabilities, in line with 21 CFR 820.100.
- Software Updates: Another pivotal point stresses the need for manufacturers to offer clear insights into their end-to-end processes that allow for software updates and patches once the device is deployed in real-world settings.
For achieving these objectives, manufacturers are counseled to either adopt design processes as detailed in the QS regulation or explore alternative frameworks. Such frameworks, however, must comply with the QS regulation and should resonate with the FDA’s recommendations, particularly those pertaining to the Security Product Development Framework (SPDF). A few noteworthy frameworks for consideration include the Medical Device and Health IT Joint Security Plan (JSP) 30, IEC 81001-5-1, or ANSI/ISA 62443-4-1.
The motivation behind the FDA’s stringent focus on cybersecurity is rooted in the escalating threats that the healthcare sector faces. Recent incidents have underscored the vulnerabilities, with cyberattacks disrupting patient care both in the U.S. and globally. Such adversities can precipitate considerable clinical hazards, such as significant delays in crucial medical diagnoses and timely treatments.
The new policy, poised to be in full swing from Oct. 1, enforces a mandate that all premarket medical device submissions be underpinned by exhaustive cybersecurity details. This includes vendor plans for postmarket vulnerabilities, methodologies for coordinated disclosure of potential exploits, and a comprehensive software bill of materials. Each submission, henceforth, should come with an assurance of the device’s security integrity and a commitment to prompt bug resolution.
Refuse to Accept Policy
This policy isn’t new to the FDA but its extension to cover the cybersecurity dimensions of medical devices marks a transformative shift. While it was officially enacted on March 29, the FDA extended a grace period up to Oct. 1, pledging collaborative assistance to device applicants in rectifying their cybersecurity gaps. However, post this grace period, the FDA is vested with the authority to instantly reject submissions that do not conform to the prescribed cybersecurity norms.
The reinforced vigilance on cybersecurity was further cemented by Congressional backing, encapsulated in the omnibus funding bill signed off by President Joe Biden on Dec. 29, 2022. This legislative endorsement, in effect, expanded the FDA’s mandate, emphasizing the cybersecurity requirements of all cyber devices, especially those with internet connectivity. Industry stalwarts, such as Phil Englert, have voiced their advocacy for the new guidelines. Manufacturers are strongly encouraged to maintain an open line of communication with the FDA, ensuring that submissions are thorough, systematically organized, and embed pivotal information effectively.
Clarity on SBOM
In 2018, the FDA released a cybersecurity premarket draft guidance which introduced the concept of a cybersecurity bill of materials (CBOM). However, this draft was met with resistance from industry insiders who found the CBOM requirements cumbersome as it demanded details on both software and hardware specifications.
Taking the feedback into account, the FDA revamped its guidance in April 2022. This revision predominantly transitioned from CBOM to SBOM (Software Bill of Materials) requirements. Notwithstanding, stakeholders sought further specifics on SBOM documentation. As Wilkerson mentioned, “Many comments focused on the software transparency or software bill of materials section… so we provided some additional detail there based on comments and feedback that we had received.”
While directing sponsors to its existing guidances like “Off-The-Shelf (OTS) Software Use in Medical Devices” and “Cybersecurity for Networked Medical Devices Containing OTS Software” for SBOM insights, the final guidance stressed the incorporation of key elements from the October 2021 NTIA document “Framing Software Component Transparency: Establishing a Common SBOM.” A salient point emphasized was ensuring SBOMs remain machine-readable. Furthermore, the FDA encouraged the inclusion of software monitoring and maintenance details in the SBOMs. However, if any manufacturer is unable to comply, they must provide a justifiable reason.
The 2023 Consolidated Appropriations Act, inclusive of the Food and Drug Omnibus Reform Act (FDORA), has expanded the FDA’s authority. This legislation cements the definition of a cyber device to encompass medical device combination products which include drug and biologic components. The guidance provided elaborate insights on when sponsors must adhere to section 524B to maintain optimal cybersecurity.
The guidance holds relevance for a vast array of devices under section 201(h) of the FD&C Act. The FDA explained, “This guidance also applies to cyber devices, as defined in section 524B of the FD&C Act, which are a subset of devices.” The guidance also touched upon specific requirements for biologics license applications (BLA) and investigational new drug (IND) applications in specific scenarios.
Highlighting the distinctions for Investigational Device Exemption (IDE) submissions, the FDA appended a list of documentation prerequisites. The agency said, “In order to ensure security is addressed early in the device design, FDA has identified a subset of the documentation recommended throughout this guidance to submit with IDE applications.”
Wilkerson emphasized the need for sponsors to focus on vulnerability and risk management, SBOM inclusion, and ensuring product patch ability. She observed that most of the guidelines were consistent with the FDA’s stance before the new authorities came into play.
Reiterating the importance of the total product lifecycle (TPLC) approach to cybersecurity, the FDA wants sponsors to view cybersecurity as a continually evolving attribute throughout a device’s lifecycle. Wilkerson summed it up by stating, “Cybersecurity is not something that you do once and then are done… Cybersecurity is something that is relevant and will have to be adapted and evolved over the entire lifecycle.”
Topics: #healthcare #lifeSciences #medicaldevices #medtech #medicaltechnology #MedSysCon #FDA #cybersecurity #PremarketNotification
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