FDA Releases Final Software Guidance Document

On June 14, 2023, the FDA released their final updated guidance document on the Content of Premarket Submissions for Device Software Functions. The document is the final version of the draft that was issued on November 4, 2021, and replaces the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices that was released in 2005.

The guidance covers device software functions, which include firmware, software accessories to medical devices, and software only functions. It applies to all types of premarket submissions that have one or more device software functions, including:

• Premarket Notification (510(k))
• De Novo Classification Request
• Premarket Approval Application (PMA)

• Investigational Device Exemption (IDE)
• Humanitarian Device Exemption (HDE)
• Biologics License Application (BLA)

The final guidance confirms many of the major updates seen in the draft guidance that we outlined in this two-part post back in 2021. However, while the draft guidance specified four risk-based criteria to determine which documentation level a device falls under (Basic Documentation or Enhanced Documentation), the final version of the guidance only requires Enhanced Documentation for the following:

• Any premarket submission that includes device software function(s) where a failure or flaw of any device software function(s) could present a hazardous situation with a probable risk of death or serious injury, either to a patient, user of the device, or others in the environment of use. These risks should be assessed prior to implementation of risk control measures. Sponsors should consider the risks in the context of the device’s intended use (e.g., impacts to safety, treatment, and/or diagnosis), and other relevant considerations.

Other risk-based criteria are mentioned in the final guidance, but Enhanced Documentation may not be required in all instances of these types of devices. The guidance notes three additional categories of device that are generally recommended to follow Enhanced Documentation recommendations for premarket submissions. These categories are:

• Devices that (a) are intended to test blood donations for transfusion-transmitted infections (b) are intended to determine blood donor and recipient compatibility (c) are automated blood cell separator devices intended for collection of blood and blood components for transfusion or further manufacturing use or (d) are blood establishment computer software (BECS)
• Devices that are a constituent part of a combination product
• Class III devices

The FDA believes that these types of products may have unique risks that require more documentation than would be provided in the Basic Documentation framework. However, the guidance qualifies that while evaluating the appropriate documentation level for a device, it may be determined that an Enhanced documentation level does not apply to certain devices that fit into one of these two categories. Detailed rationale as to why Basic Documentation was appropriate for the premarket submission should be provided in such cases. As with any submission, the FDA may request additional information they believe is needed to assess the safety and effectiveness of the device.

Examples of Basic & Enhanced Documentation

The guidance provides examples of documentation level determination using the updated criteria. While these examples do not cover every type of device, they are helpful in demonstrating how the new risk-based criteria is implemented. A few of the examples provided in the FDA guidance can be seen below:

Basic Level Documentation

An implantable sensor for measuring pulmonary artery (PA) pressure, which consists of a permanent implant that is placed in the PA and an external software-controlled reader that retrieves and transmits PA pressure measurements. The data is used by the physician for heart failure management with the goal of reducing heart failure hospitalizations. There are no device software functions located on the implant.

• This device would fall under the Basic Level of documentation according to the updated guidance. While it is a Class III device, a failure or latent flaw of the device software function(s) would not present a hazardous situation with a probable risk of death or serious injury. Any risk of death/injury in this example would be due to a failure of the hardware.

Enhanced Level Documentation

A drug-device combination, with the device constituent part detecting ingestion of the drug component to prevent treatment failure. The product is a combination product composed of two regulated components (drug and device). The “primary mode of action” is the drug component, provided as a tablet. The device constituent part detects ingestion of the tablet component to monitor adherence to the drug regimen. A missed dose greatly increases the likelihood of treatment failure for a life-threatening condition. The device constituent part includes hardware (sensors) and software (signal processing).

• This device would fall under the Enhanced Level of documentation according to the new guidelines. Although devices that are a constituent part of a combination product are no longer automatically considered to meet Enhanced Level criteria, it is one of the categories that the FDA generally recommends may have unique risks so the documentation level should be considered carefully. In this case, a failure or latent flaw of the device software function(s), such as a false detection of tablet ingestion, would present a hazardous situation with a probable risk of death or serious injury to either a patient.

More examples of documentation level determination can be found in Appendix A of the guidance.

Overall, the updated guidance document does not contain many substantial changes from the initial draft released by the FDA in 2021. Nonetheless, it is worth noting that the FDA confirms its intention of allowing the submission of a Declaration of Conformity to IEC 62304 in lieu of providing Software Development, Configuration Management, and Maintenance Practice documentation. This applies to devices that fall under both the Basic and Enhanced Documentation levels. The guidance document also provides examples of technical records, including Software Architecture Diagrams and Detailed Design records, that can be used as a resource when drafting documentation. We recommend that clients pay very close attention to these examples when preparing their submissions, or reach out to our quality engineers for support. .

If you need help interpreting the nuances of these regulations or creating efficient and effective documentation, look to Rook. We’ve been partnering with medical device companies for over a decade, and we’re here when you need us.