Regulatory Open Forum

Hello everyone,
if I know my medical device will be a De Novo, do I need to submit the De Novo request for classification, or can I go straight to the 510(k) and save 25,575.00 (for a small business like mine)? Thanks for any help!

------------------------------
Tatiana Ferreira-Black, RPh.
Austin TX
United States
------------------------------

You can do a 510(k) if there is a predicate device (a device where you can compare your device with)
If there is no predicate device you will have to go for a de-novo and it is even better to have initial contacts with FDA before submitting the denovo to ensure the de-novo will be accepted for review.
Once accepted for review it will take 12-18 months

------------------------------
Franky Dubois
QA/RA Manager
Gent
Belgium
------------------------------

Original Message:
Sent: 11-Jun-2020 16:37
From: Tatiana Ferreira-Black, RPh.
Subject: De Novo Request

Hello everyone,
if I know my medical device will be a De Novo, do I need to submit the De Novo request for classification, or can I go straight to the 510(k) and save 25,575.00 (for a small business like mine)? Thanks for any help!

------------------------------
Tatiana Ferreira-Black, RPh.
Austin TX
United States
------------------------------

Tatiana,

You can go straight to a De Novo submission - some like to call 510(k) De Novo - but as Franky indicated a true Traditional 510(k) submission has a predicate device where a De Novo does not.  They changed the process a few years ago where you had to submit a 510(k), get an NSE, then submit the request for De Novo (which was kind of automatic); now you can go directly.  He also provided very good advice, if you have not already, if a De Novo route is indeed where you heading, highly recommend to have some dialogue with FDA about the approach of the submission, i.e. clinical data, performance data, bench performance testing, validations, etc., via a Q-Submission meeting.  If you are unsure of the classification or route through premarket submission, again should have those discussions (through 513(g) request or Q-Submission) with the FDA first before just making a submission.  While it may be some time up front, it often time saves much more time than reworking submissions - plus FDA likes to see well-prepared submissions - meaning getting 510(k) submission that are De Novos and vice versa.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 12-Jun-2020 02:29
From: Franky Dubois
Subject: De Novo Request

You can do a 510(k) if there is a predicate device (a device where you can compare your device with)
If there is no predicate device you will have to go for a de-novo and it is even better to have initial contacts with FDA before submitting the denovo to ensure the de-novo will be accepted for review.
Once accepted for review it will take 12-18 months

------------------------------
Franky Dubois
QA/RA Manager
Gent
Belgium

Original Message:
Sent: 11-Jun-2020 16:37
From: Tatiana Ferreira-Black, RPh.
Subject: De Novo Request

Hello everyone,
if I know my medical device will be a De Novo, do I need to submit the De Novo request for classification, or can I go straight to the 510(k) and save 25,575.00 (for a small business like mine)? Thanks for any help!

------------------------------
Tatiana Ferreira-Black, RPh.
Austin TX
United States
------------------------------

Thank you!

Original Message:
Sent: 12-Jun-2020 02:29
From: Franky Dubois
Subject: De Novo Request

You can do a 510(k) if there is a predicate device (a device where you can compare your device with)
If there is no predicate device you will have to go for a de-novo and it is even better to have initial contacts with FDA before submitting the denovo to ensure the de-novo will be accepted for review.
Once accepted for review it will take 12-18 months

------------------------------
Franky Dubois
QA/RA Manager
Gent
Belgium

Original Message:
Sent: 11-Jun-2020 16:37
From: Tatiana Ferreira-Black, RPh.
Subject: De Novo Request

Hello everyone,
if I know my medical device will be a De Novo, do I need to submit the De Novo request for classification, or can I go straight to the 510(k) and save 25,575.00 (for a small business like mine)? Thanks for any help!

------------------------------
Tatiana Ferreira-Black, RPh.
Austin TX
United States
------------------------------

This message was posted by a user wishing to remain anonymous

I thought de novo was 150 days, not 12 - 18 months.
Original Message:
Sent: 12-Jun-2020 09:48
From: Tatiana Ferreira-Black, RPh.
Subject: De Novo Request

Thank you!

Original Message:
Sent: 12-Jun-2020 02:29
From: Franky Dubois
Subject: De Novo Request

You can do a 510(k) if there is a predicate device (a device where you can compare your device with)
If there is no predicate device you will have to go for a de-novo and it is even better to have initial contacts with FDA before submitting the denovo to ensure the de-novo will be accepted for review.
Once accepted for review it will take 12-18 months

------------------------------
Franky Dubois
QA/RA Manager
Gent
Belgium

Original Message:
Sent: 11-Jun-2020 16:37
From: Tatiana Ferreira-Black, RPh.
Subject: De Novo Request

Hello everyone,
if I know my medical device will be a De Novo, do I need to submit the De Novo request for classification, or can I go straight to the 510(k) and save 25,575.00 (for a small business like mine)? Thanks for any help!

------------------------------
Tatiana Ferreira-Black, RPh.
Austin TX
United States
------------------------------

The 150 days are those CDRH spends in its review of your De novo.  Its review clock stops when they send you a deficiency letter and doesn't resume until you submit information to address the deficiencies.  If that information doesn't fully address the deficiencies, review clock stops again and doesn't resume until you submit more information.  Rinse and repeat until all deficiencies have been addressed.

For project planning purposes, I usually assume equal time on both sides, 150 for FDA review, 150 for applicant to pull together its responses. or 300 days from submission to decision, but these timeframes can vary widely.  For De novos decided 2015-2018, by my most recent analysis, the mean time from submission to decision was 373 days, with a range of 28 to 870 days 




------------------------------
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: 12-Jun-2020 14:12
From: Anonymous Member
Subject: De Novo Request

This message was posted by a user wishing to remain anonymous

I thought de novo was 150 days, not 12 - 18 months.
Original Message:
Sent: 12-Jun-2020 09:48
From: Tatiana Ferreira-Black, RPh.
Subject: De Novo Request

Thank you!

Original Message:
Sent: 12-Jun-2020 02:29
From: Franky Dubois
Subject: De Novo Request

You can do a 510(k) if there is a predicate device (a device where you can compare your device with)
If there is no predicate device you will have to go for a de-novo and it is even better to have initial contacts with FDA before submitting the denovo to ensure the de-novo will be accepted for review.
Once accepted for review it will take 12-18 months

------------------------------
Franky Dubois
QA/RA Manager
Gent
Belgium

Original Message:
Sent: 11-Jun-2020 16:37
From: Tatiana Ferreira-Black, RPh.
Subject: De Novo Request

Hello everyone,
if I know my medical device will be a De Novo, do I need to submit the De Novo request for classification, or can I go straight to the 510(k) and save 25,575.00 (for a small business like mine)? Thanks for any help!

------------------------------
Tatiana Ferreira-Black, RPh.
Austin TX
United States
------------------------------

You do not need to submit a 510(k) first. 

If you submit a 510(k) first, they might refuse to accept it when they get to Item 4 of the RTA checklist:
4. Is this device type eligible for a 510(k) submission?

Or they might accept it and then waste more of your time while it subject it to a full 510(k) review before determining it to be NSE.

The last time I dealt with fees, they seemed kind of fluid and potentially open to negotiation.  Less flexible policies might have been established by now. but here are some ways things might possibly go:

If you pay the 510(k) fee and they RTA it, they might refund all or part of the 510(k) fee or, if you indicate that you are going to follow with a De novo, they might apply it to that fee. Or they might just keep it. 

If they do the full review, I think they will keep the fee.  Then they might want to charge you the full $25K De novo fee, or might be willing to apply the 510(k) fee to it, I can't say.


------------------------------
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: 11-Jun-2020 16:37
From: Tatiana Ferreira-Black, RPh.
Subject: De Novo Request

Hello everyone,
if I know my medical device will be a De Novo, do I need to submit the De Novo request for classification, or can I go straight to the 510(k) and save 25,575.00 (for a small business like mine)? Thanks for any help!

------------------------------
Tatiana Ferreira-Black, RPh.
Austin TX
United States
------------------------------

This message was posted by a user wishing to remain anonymous

If FDA refuses to accept your 510(k), you can request a refund of the user fee, according to this guidance:
https://www.fda.gov/media/85591/download#page=10
Original Message:
Sent: 12-Jun-2020 16:04
From: Julie Omohundro
Subject: De Novo Request

You do not need to submit a 510(k) first.

If you submit a 510(k) first, they might refuse to accept it when they get to Item 4 of the RTA checklist:
4. Is this device type eligible for a 510(k) submission?

Or they might accept it and then waste more of your time while it subject it to a full 510(k) review before determining it to be NSE.

The last time I dealt with fees, they seemed kind of fluid and potentially open to negotiation.  Less flexible policies might have been established by now. but here are some ways things might possibly go:

If you pay the 510(k) fee and they RTA it, they might refund all or part of the 510(k) fee or, if you indicate that you are going to follow with a De novo, they might apply it to that fee. Or they might just keep it.

If they do the full review, I think they will keep the fee.  Then they might want to charge you the full $25K De novo fee, or might be willing to apply the 510(k) fee to it, I can't say.


------------------------------
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: 11-Jun-2020 16:37
From: Tatiana Ferreira-Black, RPh.
Subject: De Novo Request

Hello everyone,
if I know my medical device will be a De Novo, do I need to submit the De Novo request for classification, or can I go straight to the 510(k) and save 25,575.00 (for a small business like mine)? Thanks for any help!

------------------------------
Tatiana Ferreira-Black, RPh.
Austin TX
United States
------------------------------

Thank you so much for all your input!
The MDUFA User Fee Schedule FY2020 does not show a fee for the De Novo submission, only 510(k). Does that mean I do not have to pay for the submission after de novo classification is granted, just the De Novo Classification request?

------------------------------
Tatiana Ferreira-Black, RPh. PharmD
Austin TX
United States
------------------------------

Original Message:
Sent: 11-Jun-2020 16:37
From: Tatiana Ferreira-Black, RPh.
Subject: De Novo Request

Hello everyone,
if I know my medical device will be a De Novo, do I need to submit the De Novo request for classification, or can I go straight to the 510(k) and save 25,575.00 (for a small business like mine)? Thanks for any help!

------------------------------
Tatiana Ferreira-Black, RPh.
Austin TX
United States
------------------------------

I think you just missed it somehow:

De Novo Classification Request is $102,299 or $25,575 for small business.

https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa


------------------------------
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: 15-Jun-2020 18:58
From: Tatiana Ferreira-Black, RPh.
Subject: De Novo Request

Thank you so much for all your input!
The MDUFA User Fee Schedule FY2020 does not show a fee for the De Novo submission, only 510(k). Does that mean I do not have to pay for the submission after de novo classification is granted, just the De Novo Classification request?

------------------------------
Tatiana Ferreira-Black, RPh. PharmD
Austin TX
United States

Original Message:
Sent: 11-Jun-2020 16:37
From: Tatiana Ferreira-Black, RPh.
Subject: De Novo Request

Hello everyone,
if I know my medical device will be a De Novo, do I need to submit the De Novo request for classification, or can I go straight to the 510(k) and save 25,575.00 (for a small business like mine)? Thanks for any help!

------------------------------
Tatiana Ferreira-Black, RPh.
Austin TX
United States
------------------------------

Hi,
I did a straight to De Novo submission last year.  I used the following to structure my submission.
https://www.fda.gov/media/116945/download
The FDA was extremely helpful throughout the process.  Message me if you have any questions.
Laura

------------------------------
Laura Boll
Vice President - Quality and Regulatory Affairs
Milwaukee WI
United States
------------------------------

Original Message:
Sent: 11-Jun-2020 16:37
From: Tatiana Ferreira-Black, RPh.
Subject: De Novo Request

Hello everyone,
if I know my medical device will be a De Novo, do I need to submit the De Novo request for classification, or can I go straight to the 510(k) and save 25,575.00 (for a small business like mine)? Thanks for any help!

------------------------------
Tatiana Ferreira-Black, RPh.
Austin TX
United States
------------------------------