On August 11, 2023, the Food and Drug Administration (FDA) updated the Off-The-Shelf Software Use in Medical Devices guideline about Off-The-Shelf (OTS) software used in Medical Devices to identify the minimum information to be introduced in documentation subject to premarket review by the agency.

The guideline indeed provides the necessary elements and contents to be included in the documentation to submit a premarket submission, such as Premarket Notification (510(k)), De Novo or Premarket Approval (PMA) for a medical device that integrates and uses OTS software for which the device manufacturer cannot claim complete life-cycle control (e.g., operating system and libraries).

The information to be included in the documentation depends on the risk of the device to the patient, the user or other individuals in the environment of use. To determine the minimum level of documentation FDA adopts a risk-based approach. Specifically, the latest guideline update is not based on decision trees but allows the manufacturer to conduct a risk assessment and provide an evaluation describing the features, functions and potential risks of the OTS software.

FDA, to facilitate the process, has included questions and summary tables in the guideline that provide a supporting general outline.

From a practical point of view, a risk management plan and risk management file must be included in the premarket submission documentation, whether for 510K, De Novo or PMA. Applicants specifically clarify in the risk management plan how they intend to assess the overall residual risk and include in the risk management file a risk assessment demonstrating risk reduction.

The documentation must also include the test plan and its results. Testing activities involve not only those performed by the OTS software developer, but also those performed during the validation of the OTS software for use in the specific device.

Finally, the guideline defines the requirements necessary to ensure the safe and effective operation of OTS software throughout the life cycle of the medical device by identifying some essential aspects such as general safety, effectiveness, design, software testing, verification/validation, modifications and installation.

>>> Through the strategic-regulatory consulting services, 510(k) premarket notification, De Novo and Premarket approval (PMA) drafting, also containing software, Thema can support the marketing of Medical Devices in the U.S.A. while complying with the requirements of the Food and Drug Administration.


Off-The-Shelf Software Use in Medical Devices