The Comprehensive Guide to FDA Medical Device Regulations

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.

Jump to: 

• Premarket submissions
• FDA-Mandated Cybersecurity Measures
• FDA SBOM Requirements
• Additional Regulations to Know
• How Finite State Helps Teams Achieve Compliance

Premarket Submissions

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:

• 510(k) Submissions: For devices substantially equivalent to existing products. 
• Premarket Approval (PMA): For high-risk devices that must demonstrate safety and effectiveness through extensive data, often including clinical trials. 
• De Novo Requests: For novel devices without a legally marketed predicate that require a demonstration of safety and effectiveness. 

Compliance with good clinical practice (GCP) guidelines is essential for medical devices requiring clinical data. This includes:

• Informed consent: Ensuring participants understand the study and its risks. 
• Detailed record maintenance: Maintaining transparency and accountability in clinical trials to ensure ethical conduct and reliable results. 

Refuse to Accept (RTA) Policy 

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:

• Security controls for the device
• Processes for handling vulnerability disclosures
• Software Bill of Materials (SBOM) listing all software components, including third-party and open-source elements.

Any submission that fails to meet the requirements is rejected, although manufacturers are notified of the deficiencies and allowed to address them before resubmitting.

FDA-Mandated Cybersecurity Measures

As medical devices become more interconnected, cybersecurity has become a paramount concern. Key cybersecurity requirements include:

• A cybersecurity risk management plan: Manufacturers must demonstrate clear plans to identify and mitigate potential threats and vulnerabilities. 
• Software Bill of Materials (SBOM): This compulsory document ensures transparency regarding a device's software components and dependencies to help manage risks effectively. 
• A postmarket cybersecurity plan: Manufacturers must also have a plan to monitor and address cybersecurity vulnerabilities and exploits continuously. 

The postmarket cybersecurity plan must include the following:

• How you will monitor your software for vulnerabilities
• How you will identify vulnerabilities
• How you will address both vulnerabilities and exploits in a “reasonable time” postmarket
• How you will disclose vulnerabilities and exploits to stakeholders

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.”

• “Known unacceptable vulnerabilities” must be patched on a “reasonably justified regular schedule.”
• “Critical vulnerabilities”—i.e., vulnerabilities that could cause “uncontrolled risks”—take immediate priority. They must be patched as soon as possible, even outside the regular remediation cycle.
  

More on the FDA’s SBOM Requirements

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:

• A plan to monitor, identify, and address vulnerabilities in a “reasonable time”
• Processes and procedures to provide “reasonable assurance” that the device and related systems are secure and a plan to make updates and patches available postmarket
• A comprehensive software bill of materials (SBOM). These must be machine-readable and include
  • The baseline attributes identified by the National Telecommunications and Information Administration, often referred to by the NTIA minimum element set
  • The level of support provided for each component (describing whether or not the component supplier actively maintains the component, no longer maintains it, or if the component has been abandoned or deprecated)
  • The software’s end-of-support date (if applicable)

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.

Additional Regulations to Be Aware Of

Postmarket Surveillance

Once a device is on the market, manufacturers must continuously monitor its performance to ensure ongoing safety and effectiveness. This includes: 

• Timely reporting of adverse events and device malfunctions that could cause serious injury or death under the medical device reporting (MDR) regulations. 
• Ensuring the ongoing safety and effectiveness of medical devices by implementing robust surveillance programs to identify and mitigate risks. 

Quality System Regulations (QSR) 

Manufacturers must establish and maintain quality management systems (QMS) to ensure devices consistently meet specifications and are safe for use. Key elements include: 

• Design controls to ensure devices are designed to meet user needs and intended uses.
• Production and process controls to maintain consistency and quality in manufacturing processes.
• Corrective and preventive actions (CAPA) to proactively address potential and actual problems.
• Record-keeping to provide comprehensive documentation to support compliance and traceability. 
  

Usability & Labeling Requirements

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: 

• Testing for usability: Medical device manufacturers must identify and mitigate potential user errors through rigorous testing. 
• Usability engineering: Devices must be designed to be intuitive to reduce the risk of user error. 

To comply with 21 CFR Part 801, medical devices must have accurate and informative labeling to ensure safe usage. Labeling must include: 

• Instructions for use and warnings that provide clear guidance for healthcare professionals and patients.
• Indications and contraindications that clearly state the device’s intended uses and any limitations or risks.

How Finite State Can Help Medical Device Manufacturers Meet FDA Requirements

Finite State offers a comprehensive solution designed to support compliance with FDA Regulations. Here’s how: 

• Comprehensive SBOM Solutions: Automatically generate Software Bill of Materials throughout the SDLC and easily compile detailed information on all components in your products, including open-source libraries, third-party dependencies, and custom code to improve transparency and identify potential security risks in your software supply chain.
  
• Enforcing Secure Coding Practices: Seamless integrations into existing CI/CD pipelines automatically analyze source code and compiled binaries for common security vulnerabilities and coding errors. This allows engineers to identify vulnerabilities hidden deep within legacy code and third-party libraries and detect and address issues early in the development process.
• Real-Time Threat Detection: Integrations with vulnerability databases provide up-to-date information on the latest threats and exploits, allowing for the proactive identification of potential risks before they can be exploited.
• Automate Vulnerability Identification: Using our advanced binary and source code SCA, vulnerabilities can be identified as they’re introduced across the SDLC to help teams keep applications secure.

Conclusion

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.