Bringing a new medical device to market can take years and involve countless trials, new technologies, and thorough testing and evaluation to ensure the product is safe and fit for purpose. New FDA regulations add another layer of complexity to the process and can directly impact a medical device manufacturer's financial health, reputation, and ability to operate in the market.
If a device doesn't meet their strict security standards, the FDA can reject it outright. But it doesn't stop there — they can also seize products that violate regulations, get court orders to stop the manufacture and distribution of non-compliant devices, impose hefty fines and penalties, recall products, and even withdraw previously granted market authorization.
This post will guide you through the key areas of FDA regulations for medical devices, including Section 524B(b)(3) of the Federal Food, Drug, and Cosmetic (FD&C) Act and the “Refuse to Accept” Policy and discuss how Finite State can help you achieve and maintain compliance.
Before a medical device can be marketed, manufacturers must submit detailed premarket applications to the FDA. Premarket submissions act as a critical safety checkpoint, ensuring devices meet rigorous standards for safety, effectiveness, and quality. Without premarket approval, your device cannot be legally marketed in the United States. Submissions vary based on the device’s risk level and novelty and include:
Compliance with good clinical practice (GCP) guidelines is essential for medical devices requiring clinical data. This includes:
The FDA’s RTA Policy (which became stricter in October 2023) aims to enhance the cybersecurity of medical devices, which is critical given the increasing cyber threats targeting the healthcare sector.
The policy mandates that premarket submissions for medical devices include comprehensive cybersecurity details, including:
Any submission that fails to meet the requirements is rejected, although manufacturers are notified of the deficiencies and allowed to address them before resubmitting.
As medical devices become more interconnected, cybersecurity has become a paramount concern. Key cybersecurity requirements include:
The postmarket cybersecurity plan must include the following:
The Consolidated Appropriations Act also requires medical device manufacturers to “design, develop, and maintain processes and procedures” that can reasonably assure the FDA and customers that the device (and any systems it touches) are secure and will remain secure postmarket.
As part of the FDA regulations, these processes must also make updates and patches available to the entities using these devices postmarket. The act specifies two levels of vulnerabilities these procedures must address: “known unacceptable vulnerabilities” and “critical vulnerabilities.”
As of 2023, the United States Food and Drug Administration requires medical device manufacturers to include a software bill of materials (SBOM) and plans, processes, and procedures for vulnerability remediation and mitigation in their premarket submissions.
The rationale behind the shift is laid out in the FDA’s industry guidance for cybersecurity in medical devices, which states that cyber threats to the healthcare sector have grown “more frequent and more severe, carrying increased potential for clinical impact.” These cyber-threats can make individual devices or entire networks impossible to use, disrupt diagnoses, and delay proper treatment, exposing patients to a higher risk of harm and healthcare organizations to greater financial and legal risks.
By requiring manufacturers to produce SBOMs, the FDA is making it easier for governments, manufacturers, and healthcare institutions to monitor for security risks and vulnerabilities affecting the medical device’s software. The increased transparency an SBOM provides enables teams to take a more proactive approach to software supply chain security and address concerns as soon as they become known, rather than waiting for security breaches to alert them to issues, keeping applications more secure.
An Overview of FDA SBOM-Related Requirements
The Consolidated Appropriations Act’s exact text on cybersecurity requirements can be found in section 524B(b). But in summary, the FDA requires premarket medical cyber device submissions to include the following:
When turning in this SBOM, the FDA recommends including a list of “all known vulnerabilities associated with the device and software components,” including those in the Cybersecurity and Infrastructure Security Agency’s Known Exploited Vulnerabilities Catalog. This list should include an assessment of each vulnerability’s risk and a description of how you will address these vulnerabilities.
Once a device is on the market, manufacturers must continuously monitor its performance to ensure ongoing safety and effectiveness. This includes:
Manufacturers must establish and maintain quality management systems (QMS) to ensure devices consistently meet specifications and are safe for use. Key elements include:
As part of the FDA’s regulations for medical devices, manufacturers must integrate human factors and usability engineering principles to ensure devices are safe and effective for use. This includes:
To comply with 21 CFR Part 801, medical devices must have accurate and informative labeling to ensure safe usage. Labeling must include:
Finite State offers a comprehensive solution designed to support compliance with FDA Regulations. Here’s how:
Compliance with FDA regulatory requirements is essential for the safety, effectiveness, and cybersecurity of medical devices. Product security teams play a vital role in meeting these standards, from premarket submissions to postmarket surveillance. By staying informed and proactive, you can help safeguard your devices against potential threats and contribute to the overall safety and effectiveness of medical devices in the market.
Talk to our experts to learn how Finite State can help your medical devices comply with FDA regulations today.