Use of master files can be a convenient and strategic method for SaMD manufacturers or software suppliers to provide information necessary for a US regulatory submission without disclosing confidential and/or proprietary trade secrets to business partners. For example, a software supplier of a cloud library providing medical device functionality could submit a master file to FDA containing all the necessary information to fulfill the FDA guidances:
- Content of Premarket Submissions for Device Software Functions, Guidance for Industry and Food and Drug Administration Staff, June 14, 2023
- Off-The-Shelf Software Use in Medical Devices, Guidance for Industry and Food and Drug Administration Staff, August 11, 2023
The business partner could then reference that master file in their submission. Learn more about the use of master files at this link:
