FDA Final eCopy Guidance

FDA has released a final version of the guidance “eCopy Program for Medical Device Submissions” dated Dec. 31, 2012. This indicates that section 1136 of FDASIA requires submission of an eCopy for 510(k)s, de novo, PMA, IDE, PDP and other submissions but not including 513(g)s and a few others. The eCopy must contain all information provided in paper form. It may include additional information with a reference indicated in the paper copy. A cover letter must be provided to explain any differences.Note that a 510(k) requires 2 copies and a PMA 6. The full guidance is at the link provided.

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SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

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