Regulatory Open Forum

Hello everybody

Does someone here know how long does the final approval of a device that has been developed under the Breakthrough Device Program takes?

Thank you in advance

------------------------------
Ella Sheiman
Haifa
Israel
------------------------------

Approval times for breakthrough devices are the same. What BDD grants is opportunities for priority review when you file submissions and more mechanisms for interactive review with FDA. These are detailed in the BDD guidance.

---------------------------------
Hiral Dutia
Regulatory Affairs Manager
Third Pole Therapeutics
Waltham, MA
USA
---------------------------------



Original Message:
Sent: 29-Jul-2021
From: Ella Sheiman
Subject: Breakthrough Device program timelines

Hello everybody

Does someone here know how long does the final approval of a device that has been developed under the Breakthrough Device Program takes?

Thank you in advance

------------------------------
Ella Sheiman
Haifa
Israel
------------------------------

Thank you Hiral!
But doesn't priority review shortens the time to approval?

------------------------------
Ella Sheiman
Haifa
Israel
------------------------------

Original Message:
Sent: 29-Jul-2021 18:46
From: Hiral Dutia
Subject: Breakthrough Device program timelines

Approval times for breakthrough devices are the same. What BDD grants is opportunities for priority review when you file submissions and more mechanisms for interactive review with FDA. These are detailed in the BDD guidance.

---------------------------------
Hiral Dutia
Regulatory Affairs Manager
Third Pole Therapeutics
Waltham, MA
USA

Original Message:
Sent: 29-Jul-2021
From: Ella Sheiman
Subject: Breakthrough Device program timelines

Hello everybody

Does someone here know how long does the final approval of a device that has been developed under the Breakthrough Device Program takes?

Thank you in advance

------------------------------
Ella Sheiman
Haifa
Israel
------------------------------

Hi Ella,

Because BDDs get priority review, it may help shorten the time to market especially if FDA is backlogged (as they have been recently).

The other thing I forgot to mention earlier is that for BDD, depending on your device, the risk/benefit profile, the patient population, and your negotiations with FDA, you can shift some of the clinical data collection required to a post-approval study instead of the pre-approval study.

All of these advantages (plus the ones I mentioned in my earlier post) may help shorten the overall time to market, but again, the official review times for each type of marketing application (PMA, 510k, etc) don't change.

------------------------------
Hiral Dutia
Regulatory Affairs Manager
Third Pole Therapeutics
Waltham, MA
USA
------------------------------

Original Message:
Sent: 30-Jul-2021 11:04
From: Ella Sheiman
Subject: Breakthrough Device program timelines

Thank you Hiral!
But doesn't priority review shortens the time to approval?

------------------------------
Ella Sheiman
Haifa
Israel

Original Message:
Sent: 29-Jul-2021 18:46
From: Hiral Dutia
Subject: Breakthrough Device program timelines

Approval times for breakthrough devices are the same. What BDD grants is opportunities for priority review when you file submissions and more mechanisms for interactive review with FDA. These are detailed in the BDD guidance.

---------------------------------
Hiral Dutia
Regulatory Affairs Manager
Third Pole Therapeutics
Waltham, MA
USA

Original Message:
Sent: 29-Jul-2021
From: Ella Sheiman
Subject: Breakthrough Device program timelines

Hello everybody

Does someone here know how long does the final approval of a device that has been developed under the Breakthrough Device Program takes?

Thank you in advance

------------------------------
Ella Sheiman
Haifa
Israel
------------------------------

Thank you!
That is an important advantage!
So would you suggest a company to go through this path? Will it benefit it from the point of timelines?
I know it is a very general question- but I am just trying to generalize the opinion about this pathway.

Also, would you suggest in parallel to go through a 513(g) process- in case we could not locate proper classification for the device?

Thanks
Ella

------------------------------
Ella Sheiman
Haifa
Israel
------------------------------

Original Message:
Sent: 30-Jul-2021 11:48
From: Hiral Dutia
Subject: Breakthrough Device program timelines

Hi Ella,

Because BDDs get priority review, it may help shorten the time to market especially if FDA is backlogged (as they have been recently).

The other thing I forgot to mention earlier is that for BDD, depending on your device, the risk/benefit profile, the patient population, and your negotiations with FDA, you can shift some of the clinical data collection required to a post-approval study instead of the pre-approval study.

All of these advantages (plus the ones I mentioned in my earlier post) may help shorten the overall time to market, but again, the official review times for each type of marketing application (PMA, 510k, etc) don't change.

------------------------------
Hiral Dutia
Regulatory Affairs Manager
Third Pole Therapeutics
Waltham, MA
USA

Original Message:
Sent: 30-Jul-2021 11:04
From: Ella Sheiman
Subject: Breakthrough Device program timelines

Thank you Hiral!
But doesn't priority review shortens the time to approval?

------------------------------
Ella Sheiman
Haifa
Israel

Original Message:
Sent: 29-Jul-2021 18:46
From: Hiral Dutia
Subject: Breakthrough Device program timelines

Approval times for breakthrough devices are the same. What BDD grants is opportunities for priority review when you file submissions and more mechanisms for interactive review with FDA. These are detailed in the BDD guidance.

---------------------------------
Hiral Dutia
Regulatory Affairs Manager
Third Pole Therapeutics
Waltham, MA
USA

Original Message:
Sent: 29-Jul-2021
From: Ella Sheiman
Subject: Breakthrough Device program timelines

Hello everybody

Does someone here know how long does the final approval of a device that has been developed under the Breakthrough Device Program takes?

Thank you in advance

------------------------------
Ella Sheiman
Haifa
Israel
------------------------------

Ella, like everything else, it depends. Without knowing what type of device you have it is hard to say. If you have a novel, complex, high-risk device with a lot of clinical data needed, BDD is advantageous. If that's not the case, the designation may not help as much.

As to the 513g process, again, hard to say without knowing the device and what similar devices exist on the market currently. I suggest you evaluate BDD first prior to 513g. In the course of discussions with FDA, the classification may become clear. FDA may even request that you file a 513g request after BDD.

------------------------------
Hiral Dutia
Regulatory Affairs Manager
Third Pole Therapeutics
Waltham, MA
USA
------------------------------

Original Message:
Sent: 31-Jul-2021 04:44
From: Ella Sheiman
Subject: Breakthrough Device program timelines

Thank you!
That is an important advantage!
So would you suggest a company to go through this path? Will it benefit it from the point of timelines?
I know it is a very general question- but I am just trying to generalize the opinion about this pathway.

Also, would you suggest in parallel to go through a 513(g) process- in case we could not locate proper classification for the device?

Thanks
Ella

------------------------------
Ella Sheiman
Haifa
Israel

Original Message:
Sent: 30-Jul-2021 11:48
From: Hiral Dutia
Subject: Breakthrough Device program timelines

Hi Ella,

Because BDDs get priority review, it may help shorten the time to market especially if FDA is backlogged (as they have been recently).

The other thing I forgot to mention earlier is that for BDD, depending on your device, the risk/benefit profile, the patient population, and your negotiations with FDA, you can shift some of the clinical data collection required to a post-approval study instead of the pre-approval study.

All of these advantages (plus the ones I mentioned in my earlier post) may help shorten the overall time to market, but again, the official review times for each type of marketing application (PMA, 510k, etc) don't change.

------------------------------
Hiral Dutia
Regulatory Affairs Manager
Third Pole Therapeutics
Waltham, MA
USA

Original Message:
Sent: 30-Jul-2021 11:04
From: Ella Sheiman
Subject: Breakthrough Device program timelines

Thank you Hiral!
But doesn't priority review shortens the time to approval?

------------------------------
Ella Sheiman
Haifa
Israel

Original Message:
Sent: 29-Jul-2021 18:46
From: Hiral Dutia
Subject: Breakthrough Device program timelines

Approval times for breakthrough devices are the same. What BDD grants is opportunities for priority review when you file submissions and more mechanisms for interactive review with FDA. These are detailed in the BDD guidance.

---------------------------------
Hiral Dutia
Regulatory Affairs Manager
Third Pole Therapeutics
Waltham, MA
USA

Original Message:
Sent: 29-Jul-2021
From: Ella Sheiman
Subject: Breakthrough Device program timelines

Hello everybody

Does someone here know how long does the final approval of a device that has been developed under the Breakthrough Device Program takes?

Thank you in advance

------------------------------
Ella Sheiman
Haifa
Israel
------------------------------

Thank you very much!

------------------------------
Ella Sheiman
Haifa
Israel
------------------------------

Original Message:
Sent: 02-Aug-2021 11:46
From: Hiral Dutia
Subject: Breakthrough Device program timelines

Ella, like everything else, it depends. Without knowing what type of device you have it is hard to say. If you have a novel, complex, high-risk device with a lot of clinical data needed, BDD is advantageous. If that's not the case, the designation may not help as much.

As to the 513g process, again, hard to say without knowing the device and what similar devices exist on the market currently. I suggest you evaluate BDD first prior to 513g. In the course of discussions with FDA, the classification may become clear. FDA may even request that you file a 513g request after BDD.

------------------------------
Hiral Dutia
Regulatory Affairs Manager
Third Pole Therapeutics
Waltham, MA
USA

Original Message:
Sent: 31-Jul-2021 04:44
From: Ella Sheiman
Subject: Breakthrough Device program timelines

Thank you!
That is an important advantage!
So would you suggest a company to go through this path? Will it benefit it from the point of timelines?
I know it is a very general question- but I am just trying to generalize the opinion about this pathway.

Also, would you suggest in parallel to go through a 513(g) process- in case we could not locate proper classification for the device?

Thanks
Ella

------------------------------
Ella Sheiman
Haifa
Israel

Original Message:
Sent: 30-Jul-2021 11:48
From: Hiral Dutia
Subject: Breakthrough Device program timelines

Hi Ella,

Because BDDs get priority review, it may help shorten the time to market especially if FDA is backlogged (as they have been recently).

The other thing I forgot to mention earlier is that for BDD, depending on your device, the risk/benefit profile, the patient population, and your negotiations with FDA, you can shift some of the clinical data collection required to a post-approval study instead of the pre-approval study.

All of these advantages (plus the ones I mentioned in my earlier post) may help shorten the overall time to market, but again, the official review times for each type of marketing application (PMA, 510k, etc) don't change.

------------------------------
Hiral Dutia
Regulatory Affairs Manager
Third Pole Therapeutics
Waltham, MA
USA

Original Message:
Sent: 30-Jul-2021 11:04
From: Ella Sheiman
Subject: Breakthrough Device program timelines

Thank you Hiral!
But doesn't priority review shortens the time to approval?

------------------------------
Ella Sheiman
Haifa
Israel

Original Message:
Sent: 29-Jul-2021 18:46
From: Hiral Dutia
Subject: Breakthrough Device program timelines

Approval times for breakthrough devices are the same. What BDD grants is opportunities for priority review when you file submissions and more mechanisms for interactive review with FDA. These are detailed in the BDD guidance.

---------------------------------
Hiral Dutia
Regulatory Affairs Manager
Third Pole Therapeutics
Waltham, MA
USA

Original Message:
Sent: 29-Jul-2021
From: Ella Sheiman
Subject: Breakthrough Device program timelines

Hello everybody

Does someone here know how long does the final approval of a device that has been developed under the Breakthrough Device Program takes?

Thank you in advance

------------------------------
Ella Sheiman
Haifa
Israel
------------------------------

This message was posted by a user wishing to remain anonymous

What was the type of submission? 

Original Message:
Sent: 29-Jul-2021 10:45
From: Ella Sheiman
Subject: Breakthrough Device program timelines

Hello everybody

Does someone here know how long does the final approval of a device that has been developed under the Breakthrough Device Program takes?

Thank you in advance

------------------------------
Ella Sheiman
Haifa
Israel
------------------------------

Hey Anon
It was not submitted yet- we are trying to understand the benefits for applying for Breakthrough.
Thank you :)

------------------------------
Ella Sheiman
Haifa
Israel
------------------------------

Original Message:
Sent: 29-Jul-2021 18:16
From: Anonymous Member
Subject: Breakthrough Device program timelines

This message was posted by a user wishing to remain anonymous

What was the type of submission?

Original Message:
Sent: 29-Jul-2021 10:45
From: Ella Sheiman
Subject: Breakthrough Device program timelines

Hello everybody

Does someone here know how long does the final approval of a device that has been developed under the Breakthrough Device Program takes?

Thank you in advance

------------------------------
Ella Sheiman
Haifa
Israel
------------------------------

Advamed has a breakthrough devices webinar next week.
https://advamed.formstack.com/forms/fda_breakthrough_webinar?utm_campaign=2021%20Breakthrough%20Webinar&utm_medium=email&_hsenc=p2ANqtz--1GJNB0Xg_CCXlpcN6nGttcCBFNsJEtRmaNadUSuV8JhE4BGWd9z8WBi796LVQMw_OsAmfwG95dZxFp-YMqH3zHP94Jwh06YGEPY1IYapmoVpqkpA&_hsmi=144191687&utm_content=144191687&utm_source=hs_email&hsCtaTracking=9d476464-de43-469d-94c3-dff9b02d99bc%7C21391019-6405-40a3-aaf4-43bde70c0066
Jackie

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA
------------------------------

Original Message:
Sent: 29-Jul-2021 10:45
From: Ella Sheiman
Subject: Breakthrough Device program timelines

Hello everybody

Does someone here know how long does the final approval of a device that has been developed under the Breakthrough Device Program takes?

Thank you in advance

------------------------------
Ella Sheiman
Haifa
Israel
------------------------------

Thank you very much Jackie!
Do you know what time zone is it?

------------------------------
Ella Sheiman
Haifa
Israel
------------------------------

Original Message:
Sent: 30-Jul-2021 08:51
From: Jackie Jaskula
Subject: Breakthrough Device program timelines

Advamed has a breakthrough devices webinar next week.
https://advamed.formstack.com/forms/fda_breakthrough_webinar?utm_campaign=2021%20Breakthrough%20Webinar&utm_medium=email&_hsenc=p2ANqtz--1GJNB0Xg_CCXlpcN6nGttcCBFNsJEtRmaNadUSuV8JhE4BGWd9z8WBi796LVQMw_OsAmfwG95dZxFp-YMqH3zHP94Jwh06YGEPY1IYapmoVpqkpA&_hsmi=144191687&utm_content=144191687&utm_source=hs_email&hsCtaTracking=9d476464-de43-469d-94c3-dff9b02d99bc%7C21391019-6405-40a3-aaf4-43bde70c0066
Jackie

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA

Original Message:
Sent: 29-Jul-2021 10:45
From: Ella Sheiman
Subject: Breakthrough Device program timelines

Hello everybody

Does someone here know how long does the final approval of a device that has been developed under the Breakthrough Device Program takes?

Thank you in advance

------------------------------
Ella Sheiman
Haifa
Israel
------------------------------