Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

In preparation to submit 510k application, does anyone have recent experience on how long it actually takes the FDA to make their determination once they receive form FDA 3602? Current FDA information states 60 days. 

Usually we hear within 2 - 3 weeks, but we have had ones that take longer. On one occasion after several rounds of questions, it alerted the company to a some investors acquiring stock in preparation for a hostile takeover. The smaller the business, the more straight forward the accounts, and controlled your company structure, the quicker the response. Do remember the October 1st Fiscal Year change and decide whether you want to designation for 2023-24 year or 2024-2025!

Neil

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Neil Armstrong FRAPS
MeddiQuest
Peterborough UK
Waterford Ireland
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Original Message:
Sent: 25-Apr-2024 15:16
From: Anonymous Member
Subject: Timeliness of FDA decision to determine small business designation

This message was posted by a user wishing to remain anonymous

In preparation to submit 510k application, does anyone have recent experience on how long it actually takes the FDA to make their determination once they receive form FDA 3602? Current FDA information states 60 days. 

Original Message:
Sent: 4/25/2024 3:17:00 PM
From: Anonymous Member
Subject: Timeliness of FDA decision to determine small business designation

This message was posted by a user wishing to remain anonymous

In preparation to submit 510k application, does anyone have recent experience on how long it actually takes the FDA to make their determination once they receive form FDA 3602? Current FDA information states 60 days. 

Anon,

Usually it takes 2 to 3 weeks if everything is fine - international companies sometimes can take a bit longer because of providing tax information.  Sometimes they do come back with clarification or request for further information.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
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Original Message:
Sent: 26-Apr-2024 07:03
From: James Bonds
Subject: Timeliness of FDA decision to determine small business designation

Hello Anon,

FDA will generally make any requests for additional information or clarification within 30 days.  For instance, my firm had a UK subsidiary that had been wound down due to Brexit, but still appeared in the books (and tax returns) for a few years in order to depreciate the assets.  FDA had questions about that, but were satisfied with our response. 

Original Message:
Sent: 4/25/2024 3:17:00 PM
From: Anonymous Member
Subject: Timeliness of FDA decision to determine small business designation

This message was posted by a user wishing to remain anonymous

In preparation to submit 510k application, does anyone have recent experience on how long it actually takes the FDA to make their determination once they receive form FDA 3602? Current FDA information states 60 days. 

In Jan/Feb of this year, our initial review took two weeks.  We had some deficiencies in our tax forms.  After re-sending, the approval was received roughly two weeks later.

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Tim White
RA Manager
Frisco TX
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Original Message:
Sent: 25-Apr-2024 15:16
From: Anonymous Member
Subject: Timeliness of FDA decision to determine small business designation

This message was posted by a user wishing to remain anonymous

In preparation to submit 510k application, does anyone have recent experience on how long it actually takes the FDA to make their determination once they receive form FDA 3602? Current FDA information states 60 days. 

Our experience has been much faster than 60 days.  The longest time to receive it was 23 days for US companies.  Faster for OUS companies.

That said, we always plan for 60 days to make sure we don't end up delaying the submission.

Cheers,

Melissa

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Melissa Walker FRAPS, RAC
President & CTO
Graematter, Inc.
St Louis MO
United States
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Original Message:
Sent: 25-Apr-2024 15:16
From: Anonymous Member
Subject: Timeliness of FDA decision to determine small business designation

This message was posted by a user wishing to remain anonymous

In preparation to submit 510k application, does anyone have recent experience on how long it actually takes the FDA to make their determination once they receive form FDA 3602? Current FDA information states 60 days. 

We've received the SBD anywhere between 3 days after receipt to 60 days after receipt. I've found that this depends on when during the year you send it. October and November, everything slows down since they're processing so many applications then. But in April/May, you might have a faster turnaround time! May the odds be in your favor!

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Allison Komiyama
RQM+
www.rqmplus.com
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Original Message:
Sent: 25-Apr-2024 15:16
From: Anonymous Member
Subject: Timeliness of FDA decision to determine small business designation

This message was posted by a user wishing to remain anonymous

In preparation to submit 510k application, does anyone have recent experience on how long it actually takes the FDA to make their determination once they receive form FDA 3602? Current FDA information states 60 days.