FDA Electronic Copies of Submissions Instructions

FDA issued a Q&A of instructions for provision of electronic copies of premarket submission. Maximum individual file size is 50MB and the primary format is Adobe PDF but other data formats not requiring special viewers are acceptable. An electronic copy counts as one of the requried copies for a premarket submission. Full instructions are at the link provided.

SoftwareCPR Training Courses:

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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