Regulatory Open Forum

I would welcome opinion on the following question regarding 510k submission for a Class II medical device.
In a case where a no predicate can be found with the exact same intended use, will this always lead to a de Novo or are there other options i.e. use a predicate where the indicated use is very similar?

regards
Mike

------------------------------
Mike Kilkelly
Quality Manager
Galway
Ireland
------------------------------

I think this is one of those murky questions/judgment calls that can be impossible to resolve without putting something before CDRH (pre-sub or sub, personally not a big fan of 513(g)) and seeking how it reacts.  You will want to read §807.92(a)(5) and §807.100(b)(1) and whatever musings about "intended use" versus "indication" you can find on FDA's website, and then your guess is probably as good as anyone's.


------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 13-May-2019 11:55
From: Mike Kilkelly
Subject: Predicates with similar intended use

I would welcome opinion on the following question regarding 510k submission for a Class II medical device.
In a case where a no predicate can be found with the exact same intended use, will this always lead to a de Novo or are there other options i.e. use a predicate where the indicated use is very similar?

regards
Mike

------------------------------
Mike Kilkelly
Quality Manager
Galway
Ireland
------------------------------

Thank you Julie

What are the main differences between 513(g) and Presub ? Advantages/Disadvantages
regards
Mike

------------------------------
Mike Kilkelly
Quality Manager
Galway
Ireland
------------------------------

Original Message:
Sent: 13-May-2019 18:02
From: Julie Omohundro
Subject: Predicates with similar intended use

I think this is one of those murky questions/judgment calls that can be impossible to resolve without putting something before CDRH (pre-sub or sub, personally not a big fan of 513(g)) and seeking how it reacts.  You will want to read @807.92(a)(5) and @807.100(b)(1) and whatever musings about "intended use" versus "indication" you can find on FDA's website, and then your guess is probably as good as anyone's.


------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 13-May-2019 11:55
From: Mike Kilkelly
Subject: Predicates with similar intended use

I would welcome opinion on the following question regarding 510k submission for a Class II medical device.
In a case where a no predicate can be found with the exact same intended use, will this always lead to a de Novo or are there other options i.e. use a predicate where the indicated use is very similar?

regards
Mike

------------------------------
Mike Kilkelly
Quality Manager
Galway
Ireland
------------------------------

I just noticed this question re 813(g) v Pre_Sub is addressed very well in previous post.
Thank you​

------------------------------
Mike Kilkelly
Quality Manager
Galway
Ireland
------------------------------

Original Message:
Sent: 14-May-2019 02:40
From: Mike Kilkelly
Subject: Predicates with similar intended use

Thank you Julie

What are the main differences between 513(g) and Presub ? Advantages/Disadvantages
regards
Mike

------------------------------
Mike Kilkelly
Quality Manager
Galway
Ireland

Original Message:
Sent: 13-May-2019 18:02
From: Julie Omohundro
Subject: Predicates with similar intended use

I think this is one of those murky questions/judgment calls that can be impossible to resolve without putting something before CDRH (pre-sub or sub, personally not a big fan of 513(g)) and seeking how it reacts.  You will want to read @807.92(a)(5) and @807.100(b)(1) and whatever musings about "intended use" versus "indication" you can find on FDA's website, and then your guess is probably as good as anyone's.


------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 13-May-2019 11:55
From: Mike Kilkelly
Subject: Predicates with similar intended use

I would welcome opinion on the following question regarding 510k submission for a Class II medical device.
In a case where a no predicate can be found with the exact same intended use, will this always lead to a de Novo or are there other options i.e. use a predicate where the indicated use is very similar?

regards
Mike

------------------------------
Mike Kilkelly
Quality Manager
Galway
Ireland
------------------------------

513(g) will cost you $5000 and the pre-submission is free. However, depending on the panel the pre-sub goes to, they may not want to give you definitive feedback. I have been in a situation where the panel was willing to agree to a de novo in a pre-sub and another where they refused to commit to 510(k) pathway (vs. de novo vs exempt). My opinion is to go the pre-sub route and do your due diligence to review all possible predicates with as much of a detailed defense as possible (even using the comparison table in the 510k substantial equiv guidance). You would have to do this in a 513(g) anyways. If in your interactions during the pre-sub you still cannot get reassurance from FDA that 510(k) is appropriate, but believe the 510(k) is the best way to go, I would just plan to submit the 510(k) and pay the $5000 once to have them review and work with you. Even if you get an NSE as an outcome and need to submit a de novo, you would have only paid $5,000 vs. $10,000 if you did 513g + 510k.

------------------------------
Danielle Briggeman
Clinical & Regulatory Affairs Manager
Portland ME
United States
------------------------------

Original Message:
Sent: 14-May-2019 02:40
From: Mike Kilkelly
Subject: Predicates with similar intended use

Thank you Julie

What are the main differences between 513(g) and Presub ? Advantages/Disadvantages
regards
Mike

------------------------------
Mike Kilkelly
Quality Manager
Galway
Ireland

Original Message:
Sent: 13-May-2019 18:02
From: Julie Omohundro
Subject: Predicates with similar intended use

I think this is one of those murky questions/judgment calls that can be impossible to resolve without putting something before CDRH (pre-sub or sub, personally not a big fan of 513(g)) and seeking how it reacts.  You will want to read @807.92(a)(5) and @807.100(b)(1) and whatever musings about "intended use" versus "indication" you can find on FDA's website, and then your guess is probably as good as anyone's.


------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 13-May-2019 11:55
From: Mike Kilkelly
Subject: Predicates with similar intended use

I would welcome opinion on the following question regarding 510k submission for a Class II medical device.
In a case where a no predicate can be found with the exact same intended use, will this always lead to a de Novo or are there other options i.e. use a predicate where the indicated use is very similar?

regards
Mike

------------------------------
Mike Kilkelly
Quality Manager
Galway
Ireland
------------------------------

Basic 513(g) MDUFA fee for 2019 is $4,349; the fee for a small business is $2,175.

https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/fy-2019-mdufa-user-fees

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 14-May-2019 09:52
From: Danielle Briggeman
Subject: Predicates with similar intended use

513(g) will cost you $5000 and the pre-submission is free. However, depending on the panel the pre-sub goes to, they may not want to give you definitive feedback. I have been in a situation where the panel was willing to agree to a de novo in a pre-sub and another where they refused to commit to 510(k) pathway (vs. de novo vs exempt). My opinion is to go the pre-sub route and do your due diligence to review all possible predicates with as much of a detailed defense as possible (even using the comparison table in the 510k substantial equiv guidance). You would have to do this in a 513(g) anyways. If in your interactions during the pre-sub you still cannot get reassurance from FDA that 510(k) is appropriate, but believe the 510(k) is the best way to go, I would just plan to submit the 510(k) and pay the $5000 once to have them review and work with you. Even if you get an NSE as an outcome and need to submit a de novo, you would have only paid $5,000 vs. $10,000 if you did 513g + 510k.

------------------------------
Danielle Briggeman
Clinical & Regulatory Affairs Manager
Portland ME
United States

Original Message:
Sent: 14-May-2019 02:40
From: Mike Kilkelly
Subject: Predicates with similar intended use

Thank you Julie

What are the main differences between 513(g) and Presub ? Advantages/Disadvantages
regards
Mike

------------------------------
Mike Kilkelly
Quality Manager
Galway
Ireland

Original Message:
Sent: 13-May-2019 18:02
From: Julie Omohundro
Subject: Predicates with similar intended use

I think this is one of those murky questions/judgment calls that can be impossible to resolve without putting something before CDRH (pre-sub or sub, personally not a big fan of 513(g)) and seeking how it reacts.  You will want to read @807.92(a)(5) and @807.100(b)(1) and whatever musings about "intended use" versus "indication" you can find on FDA's website, and then your guess is probably as good as anyone's.


------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 13-May-2019 11:55
From: Mike Kilkelly
Subject: Predicates with similar intended use

I would welcome opinion on the following question regarding 510k submission for a Class II medical device.
In a case where a no predicate can be found with the exact same intended use, will this always lead to a de Novo or are there other options i.e. use a predicate where the indicated use is very similar?

regards
Mike

------------------------------
Mike Kilkelly
Quality Manager
Galway
Ireland
------------------------------