Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear RAPS members,

I am trying to understand the 510(k) interactive review process. Does FDA follow a checklist for the interactive review? Do they approach each section of the submission in order of the guidance (format and content) or it can be in any order? In your experience do they send all questions in one initial email and then interact to resolve those questions or they can send questions in separate email and in any order.

Thanks in advance.

To Whom it May Concern,

The interactive review with the FDA means that they have questions which they feel can be resolved quickly with you. They will email you questions and give you a time frame to respond, typically within 24 hours may be 2 days. It is an indication they can wrap up the review of your submission relatively quickly and informally. Basically you will be "on-call" 24 hours a day to be able to respond to their questions until they have had all their questions answered.

James Monroe

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James Monroe MS, RAC
President and CEO
Somerset NJ
United States
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Original Message:
Sent: 20-Oct-2020 14:54
From: Anonymous Member
Subject: 510(k) Interactive review with FDA

This message was posted by a user wishing to remain anonymous

Dear RAPS members,

I am trying to understand the 510(k) interactive review process. Does FDA follow a checklist for the interactive review? Do they approach each section of the submission in order of the guidance (format and content) or it can be in any order? In your experience do they send all questions in one initial email and then interact to resolve those questions or they can send questions in separate email and in any order.

Thanks in advance.

Anonymous,

From my experience the interactive review occurs when FDA no longer has any questions about the substantial equivalence of the proposed device compared to the predicate device.  It is usually later in the review and occurs via email but can also be followed up with a phone call from the lead reviewer.  The questions or direction can come all at once or separately, but usually it is something your organization should be able to resolve quickly, a day or so.  


Respectfully,

will

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William Coulston PMP, MS, RAC
Quality & Regulatory Manager
San Antonio TX
United States
------------------------------

Original Message:
Sent: 20-Oct-2020 14:54
From: Anonymous Member
Subject: 510(k) Interactive review with FDA

This message was posted by a user wishing to remain anonymous

Dear RAPS members,

I am trying to understand the 510(k) interactive review process. Does FDA follow a checklist for the interactive review? Do they approach each section of the submission in order of the guidance (format and content) or it can be in any order? In your experience do they send all questions in one initial email and then interact to resolve those questions or they can send questions in separate email and in any order.

Thanks in advance.

Hello,

Along with what James and Will said, this is usually the "last step" in the  510(k) review process where they are answering some of those remaining questions.  Usually this is not big questions, but clarifications or request for additional information.  Important point about the interactive review is usually the turn-around is quick.  They typically want the information answered by the following end of business day because these are the last points they are trying to resolve to have a complete package for the 510(k) submission.  This may be one or more email requests, they do not "hold" onto many questions and then ask, typically asking for the information each time they need.  Even in the interactive review I have had phone conversations with the reviewer.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 21-Oct-2020 07:34
From: William Coulston
Subject: 510(k) Interactive review with FDA

Anonymous,

From my experience the interactive review occurs when FDA no longer has any questions about the substantial equivalence of the proposed device compared to the predicate device.  It is usually later in the review and occurs via email but can also be followed up with a phone call from the lead reviewer.  The questions or direction can come all at once or separately, but usually it is something your organization should be able to resolve quickly, a day or so.


Respectfully,

will

------------------------------
William Coulston PMP, MS, RAC
Quality & Regulatory Manager
San Antonio TX
United States

Original Message:
Sent: 20-Oct-2020 14:54
From: Anonymous Member
Subject: 510(k) Interactive review with FDA

This message was posted by a user wishing to remain anonymous

Dear RAPS members,

I am trying to understand the 510(k) interactive review process. Does FDA follow a checklist for the interactive review? Do they approach each section of the submission in order of the guidance (format and content) or it can be in any order? In your experience do they send all questions in one initial email and then interact to resolve those questions or they can send questions in separate email and in any order.

Thanks in advance.

Original Message:
Sent: 10/20/2020 2:54:00 PM
From: Anonymous Member
Subject: 510(k) Interactive review with FDA

This message was posted by a user wishing to remain anonymous

Dear RAPS members,

I am trying to understand the 510(k) interactive review process. Does FDA follow a checklist for the interactive review? Do they approach each section of the submission in order of the guidance (format and content) or it can be in any order? In your experience do they send all questions in one initial email and then interact to resolve those questions or they can send questions in separate email and in any order.

Thanks in advance.