01/04/2022
Photo by Markus Spiske on Unsplash
The US Food and Drug Administration (FDA) released a draft guidance “Content of Premarket Submissions for Device Software Functions.” The draft guidance clarifies documentation that is needed for a premarket submission for device software functions. The 21st Century Cures Act excluded certain software functions from the definition of device (see the guidance, “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act”). The draft guidance addresses these changes as well as the evolution of digital health and the recent FDA recognized consensus standards for software, which are standards that the FDA determines can support clearance or approval of a device. Using the recognized standards, sponsors can submit a declaration of conformity in a premarket application rather than a full submission. See the guidance from 2018, “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.” When finalized, the draft guidance will replace “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” from 2005.
Background
Two definitions of note are:
Software as a Medical Device (SaMD): “Software that meets the definition of a device in section 201(h) of the FD&C Act and is intended to be used for one or more medical purposes without being part of a hardware device.”
Software in a Medical Device (SiMD): “Software that meets the definition of a device in section 201(h) of the FD&C Act, and is used to control a hardware device or is necessary for a hardware device to achieve its intended use. Typically, SiMD is embedded within or is part of a hardware device.”
For additional background, you may enjoy our related blogs:
Summary of Draft Guidance
The FDA clarifies the considerations for the two documentation levels for a premarket submission, Basic or Enhanced. Basic Documentation applies if the factors for Enhanced do not apply. The four risk-based factors that apply to Enhanced Documentation are:
The device is part of a combination product.
The device is class III.
The device is used to test blood donations for infections, for donor-recipient compatibility, or is Blood Establishment Computer Software.
A failure or a flaw in the device software function could pose a risk of serious injury or death.
Considerations for Documentation Level include the software’s risk to the patient, device user, or other individuals where the device is used. The draft guidance includes a section on recommendations for information to include in premarket submissions for both Basic and Enhanced Documentation Levels. Appendix A includes Documentation Level examples.
The description of the software in the premarket application needs to include relevant details to adequately explain the functionality, such as images, flow charts, or diagrams. For modified devices, changes since the approval or clearance should be highlighted. The draft guidance provides a guide for the details to include in the description in the form of suggested questions to answer. The areas covered are:
Software specifics
Software operation
Software inputs and outputs
Additional documentation items to include in the premarket submission are:
System and Software Architecture Diagram. Appendix B includes examples.
Risk Management File
Software Requirements Specification
Software Design Specification
Software Development and Maintenance Practices
Software Testing as part of Verification and Validation
Revision Level History
Unresolved Anomalies (e.g., Bugs, Defects, or Errors)
Documentation requirements for these areas may differ based on the Documentation Level (Basic or Enhanced).
The FDA clarifies that premarket submissions should include a clear risk management plan that evaluates the overall residual risk versus the benefits for the intended use of the device. The risk assessment needs to include any “reasonably foreseeable software and hardware hazards associated with the device”, including those that may occur when the device is not used as intended. Verification of the implementation and effectiveness of risk control measures should be included in the documentation.
Submit comments through February 2 HERE.
If you are preparing a regulatory submission and need assistance, Clinical Pathways can provide training for risk management or other relevant topics that meet your needs. Contact us at info@clinicalpathwaysresearch.com.
- The Clinical Pathways Team
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