Regulatory Open Forum

I know that with a PMA FDA has 45 days in which to determine whether to file the PMA and begin a substantive review of the application.

Is there a similar timeline with a traditional 510(k)? Is there a separate number of days for an initial administrative review for a traditional 510(k) (followed by the 90 day official substantive review period) or is it all lumped into the 90 day review period?

Thanks

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Justin Baker PHD
Custom Orthopaedic Solutions
Cleveland OH
United States
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Best Regards,
Anirudh Vashishth

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510(k) applications are reviewed for their administrative completeness on receipt. When a file is considered to be administratively complete, submitter will not receive and acceptance letter. In case of administratively incomplete submissions, a "Refuse to Accept" letter is sent to the submitter within approximately 30 days of receipt of original submission.
I understand FDA is not bound to compete the review within 90 days period for 510(k) submissions. But, submitter may send a review status request after 90 days from date of receipt by FDA using form FDA 3541. Thereafter, submitter may request review status report every 30 days using the same form.


Original Message:
Sent: 11-29-2012 12:26
From: Justin Baker
Subject: Traditional 510(k): Initial Administrative Review Timeline

I know that with a PMA FDA has 45 days in which to determine whether to file the PMA and begin a substantive review of the application.

Is there a similar timeline with a traditional 510(k)? Is there a separate number of days for an initial administrative review for a traditional 510(k) (followed by the 90 day official substantive review period) or is it all lumped into the 90 day review period?

Thanks

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Justin Baker PHD
Custom Orthopaedic Solutions
Cleveland OH
United States
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Current procedure is to send out the RTA letter and request any missing information interactively while proceeding with the substantive review. Thus it appears that the administrative review, which has to be completed within 15 days of acceptance through the DCC is separate from the substantive review, which has 90 days.

This may of course change once the draft guidance becomes final.

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Jean Bigoney PHD
Managing Member
Nu Device Consulting LLC
Newport NH
United States
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Original Message:
Sent: 11-29-2012 12:26
From: Justin Baker
Subject: Traditional 510(k): Initial Administrative Review Timeline

I know that with a PMA FDA has 45 days in which to determine whether to file the PMA and begin a substantive review of the application.

Is there a similar timeline with a traditional 510(k)? Is there a separate number of days for an initial administrative review for a traditional 510(k) (followed by the 90 day official substantive review period) or is it all lumped into the 90 day review period?

Thanks

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Justin Baker PHD
Custom Orthopaedic Solutions
Cleveland OH
United States
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Yes! 15 days the timelines were introduced in FDASIA. FDA is required to perform an administrative review and refuse to file within 15 days of receipt of the application. You may be able to find more details on what is looked at in a review at this website http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketnotification510k/ucm070201.htm Thanks Shree ------------------------------------------- Srinagesh Koushik PhD RAC Damascus MD United States -------------------------------------------
Original Message: Sent: 11-29-2012 12:26 From: Justin Baker Subject: Traditional 510(k): Initial Administrative Review Timeline I know that with a PMA FDA has 45 days in which to determine whether to file the PMA and begin a substantive review of the application. Is there a similar timeline with a traditional 510(k)? Is there a separate number of days for an initial administrative review for a traditional 510(k) (followed by the 90 day official substantive review period) or is it all lumped into the 90 day review period? Thanks ------------------------------------------- Justin Baker PHD Custom Orthopaedic Solutions Cleveland OH United States -------------------------------------------

See my previous post on refuse ro file. If FDA accepts the 90 day review period starts at day 1 when they received the application. If they have more questions regarding the 510 k they will send a request for additional information which stops the clock. The submitter has 30 days to respond to the request. Within the 30 days you may provide the answers or request an extension. The extension must be a maximum of 180 days. You can request them in chunks or all at once but you only have 180 days from the beginning of the request ( new from FDASIA). If FDA is satisfied with your responses your application will be found SE and cleared of your requests were inadequate then you will be found NSE or you may withdraw your application. Shree ------------------------------------------- Srinagesh Koushik PhD RAC Damascus MD United States -------------------------------------------
Original Message: Sent: 11-29-2012 12:26 From: Justin Baker Subject: Traditional 510(k): Initial Administrative Review Timeline I know that with a PMA FDA has 45 days in which to determine whether to file the PMA and begin a substantive review of the application. Is there a similar timeline with a traditional 510(k)? Is there a separate number of days for an initial administrative review for a traditional 510(k) (followed by the 90 day official substantive review period) or is it all lumped into the 90 day review period? Thanks ------------------------------------------- Justin Baker PHD Custom Orthopaedic Solutions Cleveland OH United States -------------------------------------------

Justin, The current statement from the FDA is that a refuse to accept letter will go out in "approximately" 30 days. There is a new draft guidance, refuse to accept policy on 510(k)s, that cuts the window down to 15 days. If the FDA doesn't respond within 15 days the submission is accepted, but may be subject to requests for additional information during the substantive review. This draft guidance is part of the overhaul to the 510k process that began a few years back. Marc ------------------------------------------- Marc Sanchez Attorney and Regulatory Consultant Atlanta GA United States -------------------------------------------
Original Message: Sent: 11-29-2012 12:26 From: Justin Baker Subject: Traditional 510(k): Initial Administrative Review Timeline I know that with a PMA FDA has 45 days in which to determine whether to file the PMA and begin a substantive review of the application. Is there a similar timeline with a traditional 510(k)? Is there a separate number of days for an initial administrative review for a traditional 510(k) (followed by the 90 day official substantive review period) or is it all lumped into the 90 day review period? Thanks ------------------------------------------- Justin Baker PHD Custom Orthopaedic Solutions Cleveland OH United States -------------------------------------------

My experience is that the AI request does not stop the clock. I currently have two 510(k)s in the review cycle and in both cases, RTAs were issued within 15 days of receipt at the FDA of the submissions. In both cases, the reviewer stated explicitly that they were proceeding with the substantive review. This is because the Guidance is draft and not for implementation. I was my understanding based on the reviewer's comments that once the draft guidance becomes final, issuing an RTA will stop the clock.

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Jean Bigoney PHD
Managing Member
Nu Device Consulting LLC
Newport NH
United States
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Original Message:
Sent: 11-30-2012 08:55
From: Marc Sanchez
Subject: Traditional 510(k): Initial Administrative Review Timeline


Justin,

The current statement from the FDA is that a refuse to accept letter will go out in "approximately" 30 days. There is a new draft guidance, refuse to accept policy on 510(k)s, that cuts the window down to 15 days. If the FDA doesn't respond within 15 days the submission is accepted, but may be subject to requests for additional information during the substantive review. This draft guidance is part of the overhaul to the 510k process that began a few years back.

Marc
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Marc Sanchez
Attorney and Regulatory Consultant
Atlanta GA
United States
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Jean-

This has been my experience most recently as well. I just had a 510(k) AI request that would have been an RTA letter. Because the RTA guidance is still in draft, the reviewer stated that substantive review was said to continue upon receipt of the initial submission. The reviewer mentioned that if the additional requested information was unable to be returned within a couple days or so (we were given a set date) that the application would be put on hold. Because we responded in time, I don't believe that our application was ever put on hold and that the review clock was never stopped during the e-mail information exchanges.

Prior to my original posting, I was unaware of the RTA guidance. This discussion has been very helpful. Thanks!
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Justin Baker PHD
Custom Orthopaedic Solutions
Cleveland OH
United States
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Original Message:
Sent: 11-30-2012 09:31
From: Jean Bigoney
Subject: Traditional 510(k): Initial Administrative Review Timeline

My experience is that the AI request does not stop the clock. I currently have two 510(k)s in the review cycle and in both cases, RTAs were issued within 15 days of receipt at the FDA of the submissions. In both cases, the reviewer stated explicitly that they were proceeding with the substantive review. This is because the Guidance is draft and not for implementation. I was my understanding based on the reviewer's comments that once the draft guidance becomes final, issuing an RTA will stop the clock.

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Jean Bigoney PHD
Managing Member
Nu Device Consulting LLC
Newport NH
United States
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Original Message:
Sent: 11-30-2012 08:55
From: Marc Sanchez
Subject: Traditional 510(k): Initial Administrative Review Timeline


Justin,

The current statement from the FDA is that a refuse to accept letter will go out in "approximately" 30 days. There is a new draft guidance, refuse to accept policy on 510(k)s, that cuts the window down to 15 days. If the FDA doesn't respond within 15 days the submission is accepted, but may be subject to requests for additional information during the substantive review. This draft guidance is part of the overhaul to the 510k process that began a few years back.

Marc
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Marc Sanchez
Attorney and Regulatory Consultant
Atlanta GA
United States
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My experience is similar. I have yet to receive a RTA because the draft guidance was published in June or July and is yet to be finalized. Though I like the changes that are being implemented. Shree ------------------------------------------- Srinagesh Koushik PhD RAC Damascus MD United States -------------------------------------------
Original Message: Sent: 12-03-2012 11:31 From: Justin Baker Subject: Traditional 510(k): Initial Administrative Review Timeline Jean- This has been my experience most recently as well. I just had a 510(k) AI request that would have been an RTA letter. Because the RTA guidance is still in draft, the reviewer stated that substantive review was said to continue upon receipt of the initial submission. The reviewer mentioned that if the additional requested information was unable to be returned within a couple days or so (we were given a set date) that the application would be put on hold. Because we responded in time, I don't believe that our application was ever put on hold and that the review clock was never stopped during the e-mail information exchanges. Prior to my original posting, I was unaware of the RTA guidance. This discussion has been very helpful. Thanks! ------------------------------------------- Justin Baker PHD Custom Orthopaedic Solutions Cleveland OH United States -------------------------------------------
Original Message: Sent: 11-30-2012 09:31 From: Jean Bigoney Subject: Traditional 510(k): Initial Administrative Review Timeline My experience is that the AI request does not stop the clock. I currently have two 510(k)s in the review cycle and in both cases, RTAs were issued within 15 days of receipt at the FDA of the submissions. In both cases, the reviewer stated explicitly that they were proceeding with the substantive review. This is because the Guidance is draft and not for implementation. I was my understanding based on the reviewer's comments that once the draft guidance becomes final, issuing an RTA will stop the clock. ------------------------------------------- Jean Bigoney PHD Managing Member Nu Device Consulting LLC Newport NH United States -------------------------------------------
Original Message: Sent: 11-30-2012 08:55 From: Marc Sanchez Subject: Traditional 510(k): Initial Administrative Review Timeline Justin, The current statement from the FDA is that a refuse to accept letter will go out in "approximately" 30 days. There is a new draft guidance, refuse to accept policy on 510(k)s, that cuts the window down to 15 days. If the FDA doesn't respond within 15 days the submission is accepted, but may be subject to requests for additional information during the substantive review. This draft guidance is part of the overhaul to the 510k process that began a few years back. Marc ------------------------------------------- Marc Sanchez Attorney and Regulatory Consultant Atlanta GA United States -------------------------------------------

Hi Justin,

Per the draft guidance - The clock begins upon acceptance of the submission, your submission is deem to be accepted in 15 days, unless you recieve a request for additional information.

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM315014.pdf

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Tara Viviani RAC
Regulatory Affairs Project Manger
Focus Diagnostics, Inc.
Cypress CA
United States
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Original Message:
Sent: 11-29-2012 12:26
From: Justin Baker
Subject: Traditional 510(k): Initial Administrative Review Timeline

I know that with a PMA FDA has 45 days in which to determine whether to file the PMA and begin a substantive review of the application.

Is there a similar timeline with a traditional 510(k)? Is there a separate number of days for an initial administrative review for a traditional 510(k) (followed by the 90 day official substantive review period) or is it all lumped into the 90 day review period?

Thanks

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Justin Baker PHD
Custom Orthopaedic Solutions
Cleveland OH
United States
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Hi Justin,

I would suggest taking a look at the Refuse to Accept Draft Guidance Document. It was published in Aug. 2012 and open for comment for 45 days after that.I know it's a draft, but I think it's being "tested." FDA will do an administrative review of your submission and let you know within 15 calendar days. Maybe someone else can confirm or deny. 

Good Luck, Chris

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Chris Cain
Aliso Viejo CA
United States
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Original Message:
Sent: 11-29-2012 12:26
From: Justin Baker
Subject: Traditional 510(k): Initial Administrative Review Timeline

I know that with a PMA FDA has 45 days in which to determine whether to file the PMA and begin a substantive review of the application.

Is there a similar timeline with a traditional 510(k)? Is there a separate number of days for an initial administrative review for a traditional 510(k) (followed by the 90 day official substantive review period) or is it all lumped into the 90 day review period?

Thanks

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Justin Baker PHD
Custom Orthopaedic Solutions
Cleveland OH
United States
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