Regulatory Open Forum

Hello all,

Our world is quickly changing... per FDA Commissioner Scott Gottlieb's announcement last week that there would be "progressive" or stepped approval processes to promote innovation and the new Least Burdensome approach guidance from last week; I'm trying to sort through it all. 

I know the FDA guidance regarding progressive/stepped approval won't be released until Q1 2018, but curious if this is changing your current regulatory strategy?  Are you halting testing or submissions until everything is clarified?  

Also, I'm a bit surprised that there wasn't more chatter on our forum prior to the release.  Would love to hear your thoughts.

Thank you in advance

------------------------------
Gretchen Upton RAC
RA/QA
Texas
United States
------------------------------

Original Message------

Hello all,

Our world is quickly changing... per FDA Commissioner Scott Gottlieb's announcement last week that there would be "progressive" or stepped approval processes to promote innovation and the new Least Burdensome approach guidance from last week; I'm trying to sort through it all. 

I know the FDA guidance regarding progressive/stepped approval won't be released until Q1 2018, but curious if this is changing your current regulatory strategy?  Are you halting testing or submissions until everything is clarified?  

Also, I'm a bit surprised that there wasn't more chatter on our forum prior to the release.  Would love to hear your thoughts.

Thank you in advance

------------------------------
Gretchen Upton RAC
RA/QA
Texas
United States
------------------------------

Hello,

Yes, I think we are going to take the slow down approach.  I'm hoping all will be determined/released within Q1.  However, many follow-up <g class="gr_ gr_1867 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling ins-del" id="1867" data-gr-id="1867">guidances</g> to 21st Century Cures have been delayed.  

Kind Regards,
Gretchen

------------------------------
Gretchen Upton RAC
RA/QA
Texas
United States
------------------------------

Original Message:
Sent: 19-Dec-2017 08:17
From: Ginger Cantor
Subject: Least burdensome approach and new device approval process

Hello Gretchen,

I think you could slow down if you were only developing for the US market and had valid documented rationale for your development plan, including the testing/data you will perform and collect. This seems consistent with FDA's proposed new approach to 510(k) reviews with conformance to consensus standards instead of comparison to predicates (esp. older ones).

That said, it usually takes FDA quite a while to finalize guidance, and the majority of companies are planning to market in multiple geographies, so things don't slow down. Though you can take it into consideration, one can't wait for one agency to make up its mind or stick to a decision.

Best regards,

Ginger Cantor, MBA, RAC

Founder/Principal Consultant

Centaur Consulting LLC centaurconsultingllc@gmail.com

+1 (715) 307-1850

Original Message------

Hello all,

Our world is quickly changing... per FDA Commissioner Scott Gottlieb's announcement last week that there would be "progressive" or stepped approval processes to promote innovation and the new Least Burdensome approach guidance from last week; I'm trying to sort through it all.

I know the FDA guidance regarding progressive/stepped approval won't be released until Q1 2018, but curious if this is changing your current regulatory strategy?  Are you halting testing or submissions until everything is clarified?

Also, I'm a bit surprised that there wasn't more chatter on our forum prior to the release.  Would love to hear your thoughts.

Thank you in advance

------------------------------
Gretchen Upton RAC
RA/QA
Texas
United States
------------------------------