Rather than be mislead by half baked posts I will endeavour to...

Rather than be mislead by half baked posts I will endeavour to put forward some research.

A company can choose from basically three procedures. A 45 day, 90 day or Fast Track

For example a 45 day procedure means that the Notified Body will take 45 working days (not calendar days) to review the file and then raise review comments to be answered. In other words they are obligated to initially respond within 45 working days with comments and questions. It does not mean that the recommendation or determination is given at that time. Further review sessions are also likely after that period.

The same principle applies to the 90 day procedure.

Approval is based on successfully answering comments and questions post this initial response and so the total time taken will always be greater that the 45 or 90 working days. To the lay person the 45/90 day procedure is very misleading as it only refers to the time taken for the regulator to initially respond, not the time taken to make a determination

OncoSil were scheduled to meet face to face with the Notified Body in the UK for 4 days starting on October 6th!!

For this procedure they obtain in a open face to face setting all the comments and questions from the Regulator and have the opportunity to answer these questions during this period and also in follow up sessions. This path is more efficient as they have the opportunity to present face to face with the regulatory and to provide clarification on complex issues and more quickly address the questions raised. Even a fast Track review does not finish at the end of the face to face phase as the regulatory review can continue for several more weeks – depending on the complexity of the device or drug in question.

A little knowledge is a dangerous thing, so those who profess to know more than they really do I strongly suggest you quit while you are just a little behind!!!