FDA: Requests for Feedback on Submissions Guidance

FDA issued a final guidance Requests for Feedback on Medical Device Submissions:The Pre-Submission Program and Meetings with Food and Drug Administration Staff” dated Feb 18, 2014 which supersedes the 1999 Pre-IDE Program blue book memo and draft of this gudance issued 2012. .The guidance is at the link attached and defines the various types of interactions that can be requested, what their purpose and scope are, as well as timeframes.

Remote Webmeeting Assessments

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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