Regulatory Open Forum

​The FDA's 510(k) database shows the date that the 510(k) was "Received," while the FDA's clearance letter shows the date the 510(k) was "Dated."  These are usually not the same dates.  When they are different dates, the date in the clearance letter is always later than the date on which the database indicates that 510(k) was "Received"...often much later.

Can someone here tell me what these two dates represent?  I'm thinking "Dated" is the date of the final submission to FDA prior to clearance, and the time between "Received" and "Dated" represents time spent by FDA on review and time spent by the applicant addressing deficiencies?  Could this time also include RTA time, or is a 510(k) number not assigned until the 510(k) has been accepted?


------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

In my experience, "Received" is the receipt of the final additional information required to meet deficiencies (this is the date on the letter you get saying they received your submission). "Dated" is the date written on the last additional information you gave them. The "date of the letter" of Substantial Equivalence that FDA signs is the date of the clearance. The gap between the "date of the [clearance] letter" and the "Received" is the time it took them to review the final documentations addressing the final deficiencies. The difference between "dated and "received" could just be administrative - the regulatory person wrote down the date he/she wrote the package, but didn't get to FDA until "received" date or maybe they didn't change the original date on the documents they are modifying or they didn't change the document but changed an attachment, etc.

Also they give you the 510(k) assigned number as soon as they receive the original package. Even during e-copy review phase. So your e-copy hold letter will contain the 510(k) number and both you and the FDA can point to that as reference.

Hope you're well, Julie!

------------------------------
Clarisa Tate
VP, Product Development and Regulatory Affairs
Medical Devices Professional, RA/QA/Engineering
Bay Area, CA
USA
------------------------------

Original Message:
Sent: 27-Dec-2017 11:15
From: Julie Omohundro
Subject: 510(k) dates - "Received" vs "Dated"?

​The FDA's 510(k) database shows the date that the 510(k) was "Received," while the FDA's clearance letter shows the date the 510(k) was "Dated."  These are usually not the same dates.  When they are different dates, the date in the clearance letter is always later than the date on which the database indicates that 510(k) was "Received"...often much later.

Can someone here tell me what these two dates represent?  I'm thinking "Dated" is the date of the final submission to FDA prior to clearance, and the time between "Received" and "Dated" represents time spent by FDA on review and time spent by the applicant addressing deficiencies?  Could this time also include RTA time, or is a 510(k) number not assigned until the 510(k) has been accepted?


------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Thanks, Clarisa.  I'm getting more confused, the more I look.  It turns out there are two "Received" dates, one in the FDA database and one in the clearance letter, plus a "Dated" date in the clearance letter.

For example, the FDA database, K160799 is listed "Received" on 3/23/2016, with a Decision Date of 02/17/2017.  In the clearance letter, which is dated 02/17/2017 (the Decision Date), the 510(k) appears to have been "Dated" 11/23/2016, and also "Received"  on 11/23/2016.

Right now I'm thinking that:

- the "Received" date listed in the database is either the very first receipt of the 510(k) (prior to the RTA review), or the date of the first receipt of the 510(k) when it was complete enough to be accepted for substantive review.

- the "Dated" date in the clearance letter is the final additional information required to meet deficiencies identified during the substantive review and the "Received" date is the date FDA received that final submission.

Yes? No?

PS Hope you are well too!

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 27-Dec-2017 17:18
From: Clarisa Tate
Subject: 510(k) dates - "Received" vs "Dated"?

In my experience, "Received" is the receipt of the final additional information required to meet deficiencies (this is the date on the letter you get saying they received your submission). "Dated" is the date written on the last additional information you gave them. The "date of the letter" of Substantial Equivalence that FDA signs is the date of the clearance. The gap between the "date of the [clearance] letter" and the "Received" is the time it took them to review the final documentations addressing the final deficiencies. The difference between "dated and "received" could just be administrative - the regulatory person wrote down the date he/she wrote the package, but didn't get to FDA until "received" date or maybe they didn't change the original date on the documents they are modifying or they didn't change the document but changed an attachment, etc.

Also they give you the 510(k) assigned number as soon as they receive the original package. Even during e-copy review phase. So your e-copy hold letter will contain the 510(k) number and both you and the FDA can point to that as reference.

Hope you're well, Julie!

------------------------------
Clarisa Tate
VP, Product Development and Regulatory Affairs
Medical Devices Professional, RA/QA/Engineering
Bay Area, CA
USA

Original Message:
Sent: 27-Dec-2017 11:15
From: Julie Omohundro
Subject: 510(k) dates - "Received" vs "Dated"?

​The FDA's 510(k) database shows the date that the 510(k) was "Received," while the FDA's clearance letter shows the date the 510(k) was "Dated."  These are usually not the same dates.  When they are different dates, the date in the clearance letter is always later than the date on which the database indicates that 510(k) was "Received"...often much later.

Can someone here tell me what these two dates represent?  I'm thinking "Dated" is the date of the final submission to FDA prior to clearance, and the time between "Received" and "Dated" represents time spent by FDA on review and time spent by the applicant addressing deficiencies?  Could this time also include RTA time, or is a 510(k) number not assigned until the 510(k) has been accepted?


------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message------

Thanks, Clarisa.  I'm getting more confused, the more I look.  It turns out there are two "Received" dates, one in the FDA database and one in the clearance letter, plus a "Dated" date in the clearance letter.

For example, the FDA database, K160799 is listed "Received" on 3/23/2016, with a Decision Date of 02/17/2017.  In the clearance letter, which is dated 02/17/2017 (the Decision Date), the 510(k) appears to have been "Dated" 11/23/2016, and also "Received"  on 11/23/2016.

Right now I'm thinking that:

- the "Received" date listed in the database is either the very first receipt of the 510(k) (prior to the RTA review), or the date of the first receipt of the 510(k) when it was complete enough to be accepted for substantive review.

- the "Dated" date in the clearance letter is the final additional information required to meet deficiencies identified during the substantive review and the "Received" date is the date FDA received that final submission.

Yes? No?

PS Hope you are well too!

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Hi Julie,

I was talking about the clearance letter (PDF) Dated and Received. To answer your questions:
YES, first receipt (in my experience for the ones I did)
YES, dated is the date written on the final document and received is the date FDA received the document.


------------------------------
Clarisa Tate
VP, Product Development and Regulatory Affairs
Medical Devices Professional, RA/QA/Engineering
Bay Area, CA
USA
------------------------------

Original Message:
Sent: 27-Dec-2017 20:40
From: Julie Omohundro
Subject: 510(k) dates - "Received" vs "Dated"?

Thanks, Clarisa.  I'm getting more confused, the more I look.  It turns out there are two "Received" dates, one in the FDA database and one in the clearance letter, plus a "Dated" date in the clearance letter.

For example, the FDA database, K160799 is listed "Received" on 3/23/2016, with a Decision Date of 02/17/2017.  In the clearance letter, which is dated 02/17/2017 (the Decision Date), the 510(k) appears to have been "Dated" 11/23/2016, and also "Received"  on 11/23/2016.

Right now I'm thinking that:

- the "Received" date listed in the database is either the very first receipt of the 510(k) (prior to the RTA review), or the date of the first receipt of the 510(k) when it was complete enough to be accepted for substantive review.

- the "Dated" date in the clearance letter is the final additional information required to meet deficiencies identified during the substantive review and the "Received" date is the date FDA received that final submission.

Yes? No?

PS Hope you are well too!

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 27-Dec-2017 17:18
From: Clarisa Tate
Subject: 510(k) dates - "Received" vs "Dated"?

In my experience, "Received" is the receipt of the final additional information required to meet deficiencies (this is the date on the letter you get saying they received your submission). "Dated" is the date written on the last additional information you gave them. The "date of the letter" of Substantial Equivalence that FDA signs is the date of the clearance. The gap between the "date of the [clearance] letter" and the "Received" is the time it took them to review the final documentations addressing the final deficiencies. The difference between "dated and "received" could just be administrative - the regulatory person wrote down the date he/she wrote the package, but didn't get to FDA until "received" date or maybe they didn't change the original date on the documents they are modifying or they didn't change the document but changed an attachment, etc.

Also they give you the 510(k) assigned number as soon as they receive the original package. Even during e-copy review phase. So your e-copy hold letter will contain the 510(k) number and both you and the FDA can point to that as reference.

Hope you're well, Julie!

------------------------------
Clarisa Tate
VP, Product Development and Regulatory Affairs
Medical Devices Professional, RA/QA/Engineering
Bay Area, CA
USA

Original Message:
Sent: 27-Dec-2017 11:15
From: Julie Omohundro
Subject: 510(k) dates - "Received" vs "Dated"?

​The FDA's 510(k) database shows the date that the 510(k) was "Received," while the FDA's clearance letter shows the date the 510(k) was "Dated."  These are usually not the same dates.  When they are different dates, the date in the clearance letter is always later than the date on which the database indicates that 510(k) was "Received"...often much later.

Can someone here tell me what these two dates represent?  I'm thinking "Dated" is the date of the final submission to FDA prior to clearance, and the time between "Received" and "Dated" represents time spent by FDA on review and time spent by the applicant addressing deficiencies?  Could this time also include RTA time, or is a 510(k) number not assigned until the 510(k) has been accepted?


------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

This has always been confusing to me too, so I asked a couple reviewers over the years - which aligns with what David wrote.

The "Received" date is when it was actually received by DCC at FDA and assigned the 510(k) number.  The first time they actually see the submission files.

The "Dated" date is often referred to when the review by the actual reviewer is completed.  This usually happens when all of the last information is received from an Additional Information response or when a SE determination is made by the reviewer.

Then the file goes through the administrative review process which the "Decision" date, which is usually printed at the top of the SE letter is when it was fully accepted as being SE.

Sometimes the Dated and Decision date are only a few days apart or can sometimes be same day.  Always check the dates on the database against the actual SE letter because sometimes they are not the same.

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

Original Message:
Sent: 27-Dec-2017 11:15
From: Julie Omohundro
Subject: 510(k) dates - "Received" vs "Dated"?

​The FDA's 510(k) database shows the date that the 510(k) was "Received," while the FDA's clearance letter shows the date the 510(k) was "Dated."  These are usually not the same dates.  When they are different dates, the date in the clearance letter is always later than the date on which the database indicates that 510(k) was "Received"...often much later.

Can someone here tell me what these two dates represent?  I'm thinking "Dated" is the date of the final submission to FDA prior to clearance, and the time between "Received" and "Dated" represents time spent by FDA on review and time spent by the applicant addressing deficiencies?  Could this time also include RTA time, or is a 510(k) number not assigned until the 510(k) has been accepted?


------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

​Thanks, everyone. 

I'm interested in being able to advise clients on how long the process takes.  From that perspective, the date they first submit to FDA and the decision dates are the appropriate answer to question of How long will it take.  However, as their submission progresses, they usually become more interested in How long will this part take, so it's useful to be able to tease out, for example, RTA turn-around time vs time spent in substantive review and addressing deficiencies, and the time it takes to get a decision once you have (finally!) submitted everything needed to support a decision.

I agree it's confusing.  The different dates and terminology probably reflect some historical evolution in FDA's processes, plus, I would guess, FDA eternal struggle to avoid being blamed for delays that were not in its court.

If there are dates that the reviewer assigns to the submission, I'm probably not going to count on every reviewer assigning them in exactly the same way.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 27-Dec-2017 11:15
From: Julie Omohundro
Subject: 510(k) dates - "Received" vs "Dated"?

​The FDA's 510(k) database shows the date that the 510(k) was "Received," while the FDA's clearance letter shows the date the 510(k) was "Dated."  These are usually not the same dates.  When they are different dates, the date in the clearance letter is always later than the date on which the database indicates that 510(k) was "Received"...often much later.

Can someone here tell me what these two dates represent?  I'm thinking "Dated" is the date of the final submission to FDA prior to clearance, and the time between "Received" and "Dated" represents time spent by FDA on review and time spent by the applicant addressing deficiencies?  Could this time also include RTA time, or is a 510(k) number not assigned until the 510(k) has been accepted?


------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

​Hi Julie,

It looks like the group was able to answer your question (and it seems we all agree that FDA dates are confusing)!

In addition, I thought I'd share the Emergo calculator with you (perhaps you have used it already) - https://www.emergogroup.com/resources/united-states/fda-510k-calculator.  The calculator provides individual, shortest, longest and average clearance times (based on the time between received date and cleared date) for Traditional 510ks for specific product codes.  I have found it is a nice tool to use when trying to get an idea of trends for specific product types.

Best,

Liz

------------------------------
Elizabeth Goldstein RAC
Regulatory Affairs Project Manager
California
United States
------------------------------

Original Message:
Sent: 28-Dec-2017 11:23
From: Julie Omohundro
Subject: 510(k) dates - "Received" vs "Dated"?

​Thanks, everyone.

I'm interested in being able to advise clients on how long the process takes.  From that perspective, the date they first submit to FDA and the decision dates are the appropriate answer to question of How long will it take.  However, as their submission progresses, they usually become more interested in How long will this part take, so it's useful to be able to tease out, for example, RTA turn-around time vs time spent in substantive review and addressing deficiencies, and the time it takes to get a decision once you have (finally!) submitted everything needed to support a decision.

I agree it's confusing.  The different dates and terminology probably reflect some historical evolution in FDA's processes, plus, I would guess, FDA eternal struggle to avoid being blamed for delays that were not in its court.

If there are dates that the reviewer assigns to the submission, I'm probably not going to count on every reviewer assigning them in exactly the same way.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 27-Dec-2017 11:15
From: Julie Omohundro
Subject: 510(k) dates - "Received" vs "Dated"?

​The FDA's 510(k) database shows the date that the 510(k) was "Received," while the FDA's clearance letter shows the date the 510(k) was "Dated."  These are usually not the same dates.  When they are different dates, the date in the clearance letter is always later than the date on which the database indicates that 510(k) was "Received"...often much later.

Can someone here tell me what these two dates represent?  I'm thinking "Dated" is the date of the final submission to FDA prior to clearance, and the time between "Received" and "Dated" represents time spent by FDA on review and time spent by the applicant addressing deficiencies?  Could this time also include RTA time, or is a 510(k) number not assigned until the 510(k) has been accepted?


------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

​Thanks, Elizabeth.  The Emergo calculator is a convenient tool; worth posting and reposting now and then for those who are not aware of it.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 28-Dec-2017 13:04
From: Elizabeth Goldstein
Subject: 510(k) dates - "Received" vs "Dated"?

​Hi Julie,

It looks like the group was able to answer your question (and it seems we all agree that FDA dates are confusing)!

In addition, I thought I'd share the Emergo calculator with you (perhaps you have used it already) - https://www.emergogroup.com/resources/united-states/fda-510k-calculator.  The calculator provides individual, shortest, longest and average clearance times (based on the time between received date and cleared date) for Traditional 510ks for specific product codes.  I have found it is a nice tool to use when trying to get an idea of trends for specific product types.

Best,

Liz

------------------------------
Elizabeth Goldstein RAC
Regulatory Affairs Project Manager
California
United States

Original Message:
Sent: 28-Dec-2017 11:23
From: Julie Omohundro
Subject: 510(k) dates - "Received" vs "Dated"?

​Thanks, everyone.

I'm interested in being able to advise clients on how long the process takes.  From that perspective, the date they first submit to FDA and the decision dates are the appropriate answer to question of How long will it take.  However, as their submission progresses, they usually become more interested in How long will this part take, so it's useful to be able to tease out, for example, RTA turn-around time vs time spent in substantive review and addressing deficiencies, and the time it takes to get a decision once you have (finally!) submitted everything needed to support a decision.

I agree it's confusing.  The different dates and terminology probably reflect some historical evolution in FDA's processes, plus, I would guess, FDA eternal struggle to avoid being blamed for delays that were not in its court.

If there are dates that the reviewer assigns to the submission, I'm probably not going to count on every reviewer assigning them in exactly the same way.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 27-Dec-2017 11:15
From: Julie Omohundro
Subject: 510(k) dates - "Received" vs "Dated"?

​The FDA's 510(k) database shows the date that the 510(k) was "Received," while the FDA's clearance letter shows the date the 510(k) was "Dated."  These are usually not the same dates.  When they are different dates, the date in the clearance letter is always later than the date on which the database indicates that 510(k) was "Received"...often much later.

Can someone here tell me what these two dates represent?  I'm thinking "Dated" is the date of the final submission to FDA prior to clearance, and the time between "Received" and "Dated" represents time spent by FDA on review and time spent by the applicant addressing deficiencies?  Could this time also include RTA time, or is a 510(k) number not assigned until the 510(k) has been accepted?


------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Hi Julie,
It looks like the question got answered. David's response is pretty spot on. When I reviewed submissions, I'd often see submissions dated 3 weeks before they were 'received' (i.e. stamped in) by FDA. This could happen if the submitter dated the submission incorrectly, they didn't ship overnight, it arrived on a Friday before a 3-4 day holiday weekend, or administrative delays in the document mail center at FDA (this used to be a huge problem, not bad anymore). Feel free to message me if you have any follow up question.

Happy new year

------------------------------
Michael Nilo
Network Regulatory Partners
Portland OR
United States
------------------------------

Original Message:
Sent: 28-Dec-2017 20:26
From: Julie Omohundro
Subject: 510(k) dates - "Received" vs "Dated"?

​Thanks, Elizabeth.  The Emergo calculator is a convenient tool; worth posting and reposting now and then for those who are not aware of it.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 28-Dec-2017 13:04
From: Elizabeth Goldstein
Subject: 510(k) dates - "Received" vs "Dated"?

​Hi Julie,

It looks like the group was able to answer your question (and it seems we all agree that FDA dates are confusing)!

In addition, I thought I'd share the Emergo calculator with you (perhaps you have used it already) - https://www.emergogroup.com/resources/united-states/fda-510k-calculator.  The calculator provides individual, shortest, longest and average clearance times (based on the time between received date and cleared date) for Traditional 510ks for specific product codes.  I have found it is a nice tool to use when trying to get an idea of trends for specific product types.

Best,

Liz

------------------------------
Elizabeth Goldstein RAC
Regulatory Affairs Project Manager
California
United States

Original Message:
Sent: 28-Dec-2017 11:23
From: Julie Omohundro
Subject: 510(k) dates - "Received" vs "Dated"?

​Thanks, everyone.

I'm interested in being able to advise clients on how long the process takes.  From that perspective, the date they first submit to FDA and the decision dates are the appropriate answer to question of How long will it take.  However, as their submission progresses, they usually become more interested in How long will this part take, so it's useful to be able to tease out, for example, RTA turn-around time vs time spent in substantive review and addressing deficiencies, and the time it takes to get a decision once you have (finally!) submitted everything needed to support a decision.

I agree it's confusing.  The different dates and terminology probably reflect some historical evolution in FDA's processes, plus, I would guess, FDA eternal struggle to avoid being blamed for delays that were not in its court.

If there are dates that the reviewer assigns to the submission, I'm probably not going to count on every reviewer assigning them in exactly the same way.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 27-Dec-2017 11:15
From: Julie Omohundro
Subject: 510(k) dates - "Received" vs "Dated"?

​The FDA's 510(k) database shows the date that the 510(k) was "Received," while the FDA's clearance letter shows the date the 510(k) was "Dated."  These are usually not the same dates.  When they are different dates, the date in the clearance letter is always later than the date on which the database indicates that 510(k) was "Received"...often much later.

Can someone here tell me what these two dates represent?  I'm thinking "Dated" is the date of the final submission to FDA prior to clearance, and the time between "Received" and "Dated" represents time spent by FDA on review and time spent by the applicant addressing deficiencies?  Could this time also include RTA time, or is a 510(k) number not assigned until the 510(k) has been accepted?


------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Similar delays can occur on the other side, at the company that is sending the submission. 

If it's high priority, people will walk it through for signature and take it directly to the shipper.  Otherwise, it may get prepared (and "Dated") by one person, dropped into someone else's inbox for signature, who might or might not be in the office that day...or week, who eventually signs it and puts in their outbox, and then it eventually it makes its way back to whoever is putting the whole thing together...by which time maybe the whole thing is ready to submit or maybe someone was just being proactive in getting the letter signed when it was almost ready.

If there is a significant gap between the date the company "Dated" it and the date on which it was actually shipped, most likely it means that someone found an error or omission somewhere in the submission after it was signed and dated.  And this time of year...I wouldn't be at all surprised if at least one company doesn't send FDA a submission this week that, according to how it's dated, took a full year to get there.

(I swear there are errors that remain invisible to the human eye until the submission is signed and dated, at which point they magically appear.  That, or there is a poltergeist out there somewhere that gets a particular kick out of making mischief with regulatory submissions.)

I tend to take the date "Received" as the date it was "officially" received and logged in as a new submission, not the date on which it physically arrived at FDA.

Anyway, thanks again, everyone!


------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 02-Jan-2018 14:55
From: Michael Nilo
Subject: 510(k) dates - "Received" vs "Dated"?

Hi Julie,
It looks like the question got answered. David's response is pretty spot on. When I reviewed submissions, I'd often see submissions dated 3 weeks before they were 'received' (i.e. stamped in) by FDA. This could happen if the submitter dated the submission incorrectly, they didn't ship overnight, it arrived on a Friday before a 3-4 day holiday weekend, or administrative delays in the document mail center at FDA (this used to be a huge problem, not bad anymore). Feel free to message me if you have any follow up question.

Happy new year

------------------------------
Michael Nilo
Network Regulatory Partners
Portland OR
United States

Original Message:
Sent: 28-Dec-2017 20:26
From: Julie Omohundro
Subject: 510(k) dates - "Received" vs "Dated"?

​Thanks, Elizabeth.  The Emergo calculator is a convenient tool; worth posting and reposting now and then for those who are not aware of it.

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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 28-Dec-2017 13:04
From: Elizabeth Goldstein
Subject: 510(k) dates - "Received" vs "Dated"?

​Hi Julie,

It looks like the group was able to answer your question (and it seems we all agree that FDA dates are confusing)!

In addition, I thought I'd share the Emergo calculator with you (perhaps you have used it already) - https://www.emergogroup.com/resources/united-states/fda-510k-calculator.  The calculator provides individual, shortest, longest and average clearance times (based on the time between received date and cleared date) for Traditional 510ks for specific product codes.  I have found it is a nice tool to use when trying to get an idea of trends for specific product types.

Best,

Liz

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Elizabeth Goldstein RAC
Regulatory Affairs Project Manager
California
United States

Original Message:
Sent: 28-Dec-2017 11:23
From: Julie Omohundro
Subject: 510(k) dates - "Received" vs "Dated"?

​Thanks, everyone.

I'm interested in being able to advise clients on how long the process takes.  From that perspective, the date they first submit to FDA and the decision dates are the appropriate answer to question of How long will it take.  However, as their submission progresses, they usually become more interested in How long will this part take, so it's useful to be able to tease out, for example, RTA turn-around time vs time spent in substantive review and addressing deficiencies, and the time it takes to get a decision once you have (finally!) submitted everything needed to support a decision.

I agree it's confusing.  The different dates and terminology probably reflect some historical evolution in FDA's processes, plus, I would guess, FDA eternal struggle to avoid being blamed for delays that were not in its court.

If there are dates that the reviewer assigns to the submission, I'm probably not going to count on every reviewer assigning them in exactly the same way.

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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 27-Dec-2017 11:15
From: Julie Omohundro
Subject: 510(k) dates - "Received" vs "Dated"?

​The FDA's 510(k) database shows the date that the 510(k) was "Received," while the FDA's clearance letter shows the date the 510(k) was "Dated."  These are usually not the same dates.  When they are different dates, the date in the clearance letter is always later than the date on which the database indicates that 510(k) was "Received"...often much later.

Can someone here tell me what these two dates represent?  I'm thinking "Dated" is the date of the final submission to FDA prior to clearance, and the time between "Received" and "Dated" represents time spent by FDA on review and time spent by the applicant addressing deficiencies?  Could this time also include RTA time, or is a 510(k) number not assigned until the 510(k) has been accepted?


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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
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