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Q-Submission Meeting



US FDA has various mechanisms to facilitate interaction with the Agency regarding various applications that can be submitted for medical devices of varied risk classes. The early engagement with the Agency is facilitated through request for feedback or a meeting with the US FDA under the “Q-Submission Program”. This program enables interaction with the FDA on study and data considerations to improve quality of submissions, reduced review timelines and avoidance of unnecessary pre-clinical or clinical studies.

The applicants with an intention to apply for below listed applications may opt for a Q-Submission Meeting before making actual submissions -

The Q-submission meeting can be taken up in-person or through tele-conference. Based on the intended outcome from the interaction, there are different types of Q-Submission meetings for the applicant to choose from, such as:

  • Pre-Submission Meetings (Pre-Subs)
  • Submission Issue Requests (SIRs)
  • Study Risk Determinations
  • Informational Meetings

The device manufacturers find the whole process of Q-submission program overwhelming and challenging, owing to below listed reasons –

  • Determining the objective and expected outcome from the meeting
  • Presenting appropriate device information
  • Framing correct set of questions
  • Evaluation of available types of meeting and making the right choice
  • Choosing appropriate method of feedback
Freyr Expertise and Advantages

Freyr Expertise

  • Support for original, supplement and amendment Q-Submission
  • Analysis of device documents
  • Evaluation and finalization of appropriate meeting pathway
  • Compilation of submission package
  • Compilation of meeting package
  • Meetings for medical device submissions
  • Representation during the Q-Submission FDA Meeting
  • Post Q-Sub activities

Freyr Advantages

  • In-depth understanding of FDA Q-Submission program and meetings process
  • Previous experience of executing Q-Submission projects for different categories of Medical Devices
  • Offices based out of the US for better execution and communication