Get the eCopy Validation Module for Medical Device Submissions

U.S. Food and Drug Administration sent this bulletin at 03/25/2021 01:16 PM EDT

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US Food and Drug Administration

Get the eCopy Validation Module for Medical Device Submissions

The module helps manufacturers improve the success rate for incoming submissions

eCopy Validation Module for Medical Device Submissions

The U.S. Food and Drug Administration (FDA) provides several resources to help manufacturers prepare a valid electronic copy (eCopy) for medical device submissions. These resources include the eCopy Validation Module.

Using the validation module may reduce the number of eCopy failures and holds placed on a submission. To ensure your submission meets technical standards, the FDA recommends using the eCopy Validation Module.

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The eCopy Validation Module is intended to help manufacturers:

  • Verify the format of an eCopy and provide information on the error(s) contained in an eCopy submission.
  • Conduct an analysis of the technical standards needed to submit an eCopy.
  • Provide reasons the submission does not meet technical standards or confirm the submission meets the technical standards in the eCopy guidance, eCopy Program for Medical Device Submissions.

Questions?

If you have questions about using the eCopy validation module, contact CDRH-eCopyinfo@fda.hhs.gov.