Application and Challenges of Off-The-Shelf Software in Medical Devices
With the intelligence and informatization of medical devices, many off-the-shelf software (OTS) are being applied in medical devices. On August 11, 2023, the FDA released the Guidance for Industry and Food and Drug Administration Staff on Off-The-Shelf Software Use in Medical Devices, which aims to provide information that applicants should include in the documentation submitted … Read more