Regulatory Open Forum

Dear Colleagues,

Hello.  I have two questions for input related to the guidance: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program, Jan 2021.

1)  For what types of discussions or reasons have you used Informational Meetings?  Were they helpful?

2)  Within this guidance, I would appreciate an explanation on the second part of this paragraph (pg 7):

"Generally, Informational Meetings, as described in Section III.D of this guidance, are intended
for a submitter to provide information to FDA without the expectation of feedback from FDA.
However, when Informational Meeting Q-Subs are used for tracking purposes in situations when
a formal Q-Sub type for that interaction has not been created, feedback may be provided as
prescribed by the program for which the Informational Meeting Q-Sub type is being used."

Thank you for your input and consideration.

Cheers,

Andy Hadd

Dear Colleagues,

Hello.  I have two questions for input related to the guidance: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program, Jan 2021.

1)  For what types of discussions or reasons have you used Informational Meetings?  Were they helpful?

2)  Within this guidance, I would appreciate an explanation on the second part of this paragraph (pg 7):

"Generally, Informational Meetings, as described in Section III.D of this guidance, are intended
for a submitter to provide information to FDA without the expectation of feedback from FDA.
However, when Informational Meeting Q-Subs are used for tracking purposes in situations when
a formal Q-Sub type for that interaction has not been created, feedback may be provided as
prescribed by the program for which the Informational Meeting Q-Sub type is being used."

Thank you for your input and consideration.

Cheers,

Andy Hadd

Dear Colleagues,

Hello.  I have two questions for input related to the guidance: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program, Jan 2021.

1)  For what types of discussions or reasons have you used Informational Meetings?  Were they helpful?

2)  Within this guidance, I would appreciate an explanation on the second part of this paragraph (pg 7):

"Generally, Informational Meetings, as described in Section III.D of this guidance, are intended
for a submitter to provide information to FDA without the expectation of feedback from FDA.
However, when Informational Meeting Q-Subs are used for tracking purposes in situations when
a formal Q-Sub type for that interaction has not been created, feedback may be provided as
prescribed by the program for which the Informational Meeting Q-Sub type is being used."

Thank you for your input and consideration.

Cheers,

Andy Hadd

Dear Colleagues,

Hello.  I have two questions for input related to the guidance: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program, Jan 2021.

1)  For what types of discussions or reasons have you used Informational Meetings?  Were they helpful?

2)  Within this guidance, I would appreciate an explanation on the second part of this paragraph (pg 7):

"Generally, Informational Meetings, as described in Section III.D of this guidance, are intended
for a submitter to provide information to FDA without the expectation of feedback from FDA.
However, when Informational Meeting Q-Subs are used for tracking purposes in situations when
a formal Q-Sub type for that interaction has not been created, feedback may be provided as
prescribed by the program for which the Informational Meeting Q-Sub type is being used."

Thank you for your input and consideration.

Cheers,

Andy Hadd

Dear Colleagues,

Hello.  I have two questions for input related to the guidance: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program, Jan 2021.

1)  For what types of discussions or reasons have you used Informational Meetings?  Were they helpful?

2)  Within this guidance, I would appreciate an explanation on the second part of this paragraph (pg 7):

"Generally, Informational Meetings, as described in Section III.D of this guidance, are intended
for a submitter to provide information to FDA without the expectation of feedback from FDA.
However, when Informational Meeting Q-Subs are used for tracking purposes in situations when
a formal Q-Sub type for that interaction has not been created, feedback may be provided as
prescribed by the program for which the Informational Meeting Q-Sub type is being used."

Thank you for your input and consideration.

Cheers,

Andy Hadd

Dear Colleagues,

Hello.  I have two questions for input related to the guidance: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program, Jan 2021.

1)  For what types of discussions or reasons have you used Informational Meetings?  Were they helpful?

2)  Within this guidance, I would appreciate an explanation on the second part of this paragraph (pg 7):

"Generally, Informational Meetings, as described in Section III.D of this guidance, are intended
for a submitter to provide information to FDA without the expectation of feedback from FDA.
However, when Informational Meeting Q-Subs are used for tracking purposes in situations when
a formal Q-Sub type for that interaction has not been created, feedback may be provided as
prescribed by the program for which the Informational Meeting Q-Sub type is being used."

Thank you for your input and consideration.

Cheers,

Andy Hadd