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FDA New Guidance on Q-Submission Meetings for Devicemakers- Q-submission process

  • By: Staff Editor
  • Date: June 11, 2018
  • Source: https://www.fda.gov
Abstract:

On June 7 2018 FDA has released new draft guidance related to meetings devicemakers may request under the agency’s Pre-Submission Program — it is also known as Q-submission meetings as the agency assigns applications a Q number.

 
 
The term “Q-Submission” or “Q-Sub” refers to the system used to track the collection of interactions These are important opportunities for submitters to share information with FDA and receive input outside of the submission of an IDE, IND, marketing submission, or CW. The interactions tracked in the Q-Sub program may be used at different points along the total product life cycle for a device and are voluntary.
 
The draft guidance covers various categories of device-related submissions, - IDE, PMA, HDE, De Novo request, 510(k), Dual,
 BLA, IND , humanitarian device exemptions. it also applies to pre-submission feedback and certain INDs

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