FDA Instructions for e-copies of submissions

The link provided contains instructions for those who would like to reduce the number of paper copies provided for submissions. An electronic copy can be provided in place of one of the paper copies of a submission. This eliminates the need for FDA to image the paper copies for internal use. Note that an electronic copy is not a full electronic submission. Also note that there are some specific folder naming conventions that must be followed or the e-copy will be rejected.

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IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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