Documentation Requirements for Firmware in a 510(k) Submission

DCONN1

Starting to get Involved
#1
I'm trying to determine the requirements for firmware incorporated into devices with respect to 510(k) documentation requirements. Is the software section of a 510(k) and the FDA software guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" reserved specifically for software, or are all of the requirements spelled out in this guidance applicable to firmware?

I don't yet have the requisite number of posts for links and couldn't figure out how to include the link for the guidance document as plain text; if a moderator or more senior member could please assist it would be appreciated.

The Scope section of the FDA guidance document is as follows:

Scope

For the purposes of this document, we refer to devices that contain one or more software components, parts, or accessories, or are composed solely of software as “software devices,” including:

- firmware and other means for software-based control of medical devices

- stand-alone software applications

- software intended for installation in general-purpose computers

- dedicated hardware/software medical devices.

- accessories to medical devices when those accessories contain or are composed of software.

This guidance applies to software devices regardless of the means by which the software is delivered to the end user, whether factory-installed, installed by a third-party vendor, or field-installed or -upgraded.

Software not covered by this guidance includes software designed for manufacturing or other process-control functions but not intended for use as a device. For further information or to clarify the requirements for your device, please contact the responsible FDA review division.

This guidance document applies to all types of premarket submissions for software devices, including:

Premarket Notification (510(k)) including Traditional, Special, and Abbreviated submissions
Premarket Approval Application (PMA)
Investigational Device Exemption (IDE)
Humanitarian Device Exemption (HDE), including amendments and supplements.
This is the only section in which "firmware" is mentioned. If a device has only firmware and no software, is it subject to this guidance document? According to this scope, if a device contains "firmware and other means for software-based control of medical devices", it is considered a "software device" and subject to the guidance. However, there are no mentions of firmware anywhere else in the document, only software. There is no explanation or definitions given to these terms in the document and perhaps subsequent mentions of "software" apply to both software and firmware.

As a disclaimer, I have only a high-level understanding of the differences between software and firmware and no clear insight into the differing development processes (if any) behind them. Are the required documents listed by the FDA in this guidance document applicable to both software and firmware?
 
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yodon

Staff member
Super Moderator
#2
Yes, "current thinking" considers firmware as software. Do the level of concern assessment and have the documents indicated.

Here's the link to the guidance: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089543.htm

Here are a few other links to guidance docs you might find useful:
* http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm085281.htm
* http://www.fda.gov/downloads/medica...onandguidance/guidancedocuments/ucm073779.pdf (in case your firmware contains any OTS sw)

Note that the FDA does recognize IEC 62304:2006 (and amendment 1 from 2015) as a consensus standard and compliance to that is expected if you go to the EU (and note they are pretty clear that firmware is considered software for the sake of compliance).
 
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