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Final Guidance for Submission of Off-The-Shelf Software in Medical Devices



On August 11, the FDA released the Final Guidance Off-the-Shelf Software Use in Medical Devices. The document, which supersedes Off-The-Shelf Software Use in Medical Devices issued September 27, 2019, provides information on recommended documentation sponsors should include in a premarket submission for FDA’s evaluation of off-the-shelf (OTS) software used in a medical device.

It includes nonbinding recommendations on:

  • Description of OTS Software to address each of the following questions:
    • What is it?
    • What are the Computer System Specifications for the OTS Software?
    • How will you assure appropriate actions are taken by the End User?
    • What does the OTS Software do?
    • How do you know it works?
    • How will you keep track of (control) the OTS Software?
  • Risk Assessment, including submission of a risk management file that covers risk assessment based on software functions as well as a risk management plan
  • Software Testing as Part of Verification and Validation, to include both testing activities performed by the OTS software developer and the sponsor when qualifying the OTS software for its use in the specific medical device.
  • Assurance of Development Methodologies and Continued Maintenance of OTS Software
  • Master Files for Devices (MAFs)
  • OTS Software Changes requiring a 510(k)
  • Investigational Device Exemption and Changes to OTS Software
  • Premarket Approval, including clinical evidence, if needed, to support a reasonable assurance of safety and effectiveness of the device; the extent to which the medical device manufacturer ensures that the OTS software was developed using appropriate life cycle control depending upon the overall risk of the medical device; the role of the OTS software; and the probable risk of death or serious injury, either to a patient, user of the device, or others in the environment of use
  • Product Labeling

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