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FDA Q-submission

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FDA Q-submission

FDA Q-submission

A structured process for managing and tracking interactions between manufacturers and FDA about future applications for approval or clearance, prior to the following submissions: 

Investigational Device Exemption (I DE)
Premarket Approval (PMA)
Humanitarian Device Exemption (HDE)
Premarket Notification(510(k))
De Novo Request
Clinical Laboratory Improvement Amendments (CLIA) Waiver by Applications (CW)
Dual 510(K)
Certain Investigational New Drug Applications (INDs)
Biologics License Applications (BLAs)

Q submission Program includes

IIPre-Submissions (Pre-Sub): A Pre-Submission request is usually made before any premarket submission like IDE, PMA, HDE, De Novo request, 510(k), Dual, BLA, IND for any specific questions regarding product development or submission preparation or clinical/nonclinical evaluation. This request is responded with written feedback or meeting with the FDA.
Submission Issue Request (SI): SIR is a request for FDA feedback on the issues that raised during a marketing submission like PMA, HDE, De Novo request, 510(k), Dual, or BLA. under SI formal written feedback or meetings are the options for the interaction with the FDA. SI is not used for the discussion of final decisions on the marketing submission.
Study Risk Determination (SRD): A Study Risk Determination is a request for FDA to determine if a clinical evaluation study of specific medical device is significant risk (SR), non-significant risk (NSR), or exempt from IDE regulations as defined by the IDE regulations.
Informational Meeting: An Informational Meeting is a request to the FDA to share the information about device development process or novel product technology without any feedback from the FDA. These meetings help FDA to get acquainted with device before marketing submission.

Other interactions that are tracked under Q submission

  • PMA Day 100 Meeting
  • Agreement and Determination Meeting
  • Breakthrough Devices Program
  • Accessory Classification Request

Submission Process

Content (In English): OMC Medical – omcmedical.com
  • Q-sub Cover Letter
  • Purpose
  • Device or Product Description
  • Proposed Indication for Use or Intended Use
  • Regulatory History

How to submit?

  • eCopy of your Q-Sub
  • Q-Sub should be mailed to the CDRH Document Control Center (DCC) or the CBER DCC.

Timeline & Method of Feedback of Q-Sub

  • OMC Medical - omcmedical.com

OMC Medical can assist you with the Q Submission process and contact us at info@omcmedical.co.uk

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