23
Mar
2024

Master Files

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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:

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/device-master-files

About the author

Brian is a biomedical software engineer - whatever that is! Started writing machine code for the Intel 8080 in 1983. Still enjoys designing and developing code. But probably enjoys his garden more now and watching plants grow ... and grandkids grow!

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