Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

We are trying to decide if the HUD/HDE pathway offers any benefits for us. So far I have a very long list of cons, and not so many pros. I've spent some time looking into HUD/HDE, so I understand the basics, but some questions remain:

1. Are Breakthrough Devices eligible for HUD designation? (does it matter?)

• Cannot find any mention of Breakthrough Devices (or EAPs) in HUD or HDE guidances released in Sept 2019

2. Are HDE recent trends for review longer than PMAs?

• One source I found stated between 2012-2016, HDE avg review days = 671 (compared to average PMA review days in 2015 = 276)

3. If a competitor is granted de novo or PMA for a similar device, could this potentially revoke our HUD?

• Research indicates if HUD criteria is no longer met, FDA could re-evaluate (potentially revoke) HUD designation

4. Can HDE holders later pursue a PMA pathway?

• I think yes, because at that point the HUD would be revoked, but not sure.

Thanks for any insights.

Some of the benefits of an HDE application are the waive of the pre-PMA inspection, no requirement to show clinical effectiveness and no PMA application fee. There are also shorter review times which can be helpful when doing a modular submission. Since an HDE is a type of PMA, the Breakthrough Devices Program would still be an option. The Breakthrough program lends more benefit before submission while the HDE is during submission. However, your questions 3 and 4 are correct. If a competitor is granted a de novo or approval of a PMA, your device will no longer qualify for HDE status and you will need to refile as a PMA. The same is correct in the event your patient population exceeds 8000/year. So in that, you can later pursue a PMA. I can't speak too much to the average review time for most HDE submissions, but our two HDEs did take significantly less than the 671 days you reference.  When making the decision to file a HDE or a PMA, it is best to think in the future for your device and how it will be used 5, 10, 15 years from now. Could the population or indications expand? Will you have the clinical data at the time of filing?

Hope this helps.

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Mica Elizalde, RAC
Project Manager II, Regulatory & Quality
Salt Lake City UT
United States
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Original Message:
Sent: 04-Feb-2020 16:22
From: Anonymous Member
Subject: HUD & HDE questions

This message was posted by a user wishing to remain anonymous

Hello,

We are trying to decide if the HUD/HDE pathway offers any benefits for us. So far I have a very long list of cons, and not so many pros. I've spent some time looking into HUD/HDE, so I understand the basics, but some questions remain:

1. Are Breakthrough Devices eligible for HUD designation? (does it matter?)

• Cannot find any mention of Breakthrough Devices (or EAPs) in HUD or HDE guidances released in Sept 2019

2. Are HDE recent trends for review longer than PMAs?

• One source I found stated between 2012-2016, HDE avg review days = 671 (compared to average PMA review days in 2015 = 276)

3. If a competitor is granted de novo or PMA for a similar device, could this potentially revoke our HUD?

• Research indicates if HUD criteria is no longer met, FDA could re-evaluate (potentially revoke) HUD designation

4. Can HDE holders later pursue a PMA pathway?

• I think yes, because at that point the HUD would be revoked, but not sure.

Thanks for any insights.