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510(k) RTAs - Most Common Reasons for Refusal?

  • 1.  510(k) RTAs - Most Common Reasons for Refusal?

    Posted 24-Jul-2017 19:51
    ​Has anyone seen any presentation by FDA regarding the most common reasons for a 510(k) RTA? 

     Have any consultants here seen enough RTAs to have gotten some idea of what the most common problems are?

    I know the early implementation was choppy, but it seems that things should have settled down enough now for some type of profile to emerge, starting with the percentage that are refused for "administrative" reasons...forms being omitted or done incorrectly versus because the 510(k) itself is actually incomplete somehow?

    ------------------------------
    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
    ------------------------------


  • 2.  RE: 510(k) RTAs - Most Common Reasons for Refusal?

    Posted 25-Jul-2017 17:41
    I asked a few reviewers for their opinion. They agreed that they generally reject for substance reasons but add in the administrative issues as well. If it were just administrative, then they would likely work interactively to not reject. In my experience, test reports not being in English, even if they are summarized elsewhere in English will get a rejection every time.

    ------------------------------
    Michael Nilo
    Network Regulatory Partners
    Nilo Medical Consulting Group
    Portland OR
    United States
    ------------------------------

    Original Message


  • 3.  RE: 510(k) RTAs - Most Common Reasons for Refusal?

    Posted 25-Jul-2017 19:08

    ​Hi Julie,

    I've seen similar things to what you mentioned and what Michael commented - based on discussions with FDA reviewers, it seems that, although the intention of the RTA process is to pick up administrative deficiencies, the process has been used to pick up substantive deficiencies.  It can be frustrating to get substantive questions during the RTA process, but ultimately I believe it is being done to help reviewers (with the review clock) and also industry (with limitations in allowable AI cycles, etc).  I'm not sure if this practice is consistent across different review panels, but it seems that we have all seen similar practices, so I am guessing it isn't isolated to one...

    -Liz



    ------------------------------
    Elizabeth Goldstein RAC
    Regulatory Affairs Specialist
    Medtronic Vascular
    Santa Rosa CA
    United States
    ------------------------------

    Original Message


  • 4.  RE: 510(k) RTAs - Most Common Reasons for Refusal?

    Posted 25-Jul-2017 20:55
    I agree with Elizabeth's assessment. I'd also like to add that typically the "substantive" comments still fall within the RTA checklist. There is a lot of leeway there, especially when a special controls document is available, to make sure the correct type of testing was performed.

    ------------------------------
    Michael Nilo
    Network Regulatory Partners
    Nilo Medical Consulting Group
    Portland OR
    United States
    ------------------------------

    Original Message


  • 5.  RE: 510(k) RTAs - Most Common Reasons for Refusal?

    Posted 26-Jul-2017 03:15
    Hi again,

    I find that the RTAs are more accurate now that the reviewer is conducting the assessment.  I recall a few of my submissions in the early days of RTA conducted by admin staff pinged me for info that was actually in the submission, but they either didn't look closely or didn't understand the context to accurately assess the content.  

    Also, if I'm going to get substantive content questions/deficiencies, I'd much rather get them during RTA than at the end of SR.  For example, if your reviewer asks for additional testing that you didn't foresee, being able to conduct the testing and respond to the deficiency with exactly what is expected is much easier to accomplish during RTA where time is on YOUR side.  

    You can go through multiple rounds of RTAs, but SR is only one round.  If you can't resolve AIs in 180 days, you pretty much have to withdraw and resubmit. 


    ------------------------------
    Tina O'Brien RAC, MS
    Director of Regulatory Affairs
    Aroa Biosurgery
    Auckland
    New Zealand
    ------------------------------

    Original Message


  • 6.  RE: 510(k) RTAs - Most Common Reasons for Refusal?

    Posted 09-Aug-2017 02:30
    Is there somewhere in regulation or law that limits SR to one for a 510k?  It might be recent policy, but I have for certain, in the past received several AIs that stopped the clock.  Now the agency seems only wanting to stop the clock once which I think is going to pressure industry to withdraw and resubmit which is undue burden.  Does anyone know if it's possible to push back on this stopping the clock only once policy?

    Thanks,

    Karen Jaffe, MS, MBA, RAC

    ------------------------------
    Karen Jaffe, MS MBA RAC
    Sr Director, RA/CA
    CA
    USA
    ------------------------------

    Original Message


  • 7.  RE: 510(k) RTAs - Most Common Reasons for Refusal?

    Posted 09-Aug-2017 10:02
    Hi Karen,

    A colleague of mine attended AMDM back in April and at the 510(k) workshop, FDA announced that the max review time for a 510(k) will be 180 days (90 day standard plus one hold/extension).  FDA indicated that any submission that does not have a decision by the review deadline will be "refuse to accept" by the Agency and the manufacturer will be required to resubmit with a new MDUFA fee. This is not aligned with my most recent submission in 2016, where two holds were granted.

    ------------------------------
    Katherine Edwards RAC
    Regulatory Affairs Project Manager
    MD
    USA
    ------------------------------

    Original Message


  • 8.  RE: 510(k) RTAs - Most Common Reasons for Refusal?

    Posted 09-Aug-2017 19:01
    ​Trying to make sense of all this.

    Here's what FDA's website says about the Acceptance Review:

    A 510(k) not accepted for review is placed on RTA Hold.  The submitter has 180 calendar days to fully address the deficiencies cited in the RTA Hold.  If this is not done, the 510(k) is considered withdrawn and deleted from our review system. If the 510(k) is deleted, the 510(k) submitter will need to submit a new, complete 510(k) to pursue FDA marketing clearance for that device.

    Is this still the case?


    And here's what it says about the Substantive Review:

    If FDA does not receive a complete response to all deficiencies in the AI Request within 180 days of the date of the AI Request, the submission will be considered withdrawn and deleted from our review system. If the 510(k) is deleted, the 510(k) submitter will need to submit a new 510(k) to pursue FDA marketing clearance for that device.

    Is this still the case?

    What about when you put the two together (if anyone has had the misfortune)?  Can you take 180 days to address the acceptance deficiencies and another 180 to address the AI Request?

    And then how do these timeframes fit into the actual "review" time?  To me, that's always referred to FDA's time, not the time spent waiting for you respond.  Something like this?

    15 FDA days for Acceptance Review
    180 company days to address deficiencies
    [ACCEPTANCE]
    X FDA days (90 max) for Substantive Review
    180 company days to address deficiencies
    90-X FDA days to review deficiencies
    [SE or NSE]

    ------------------------------
    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


  • 9.  RE: 510(k) RTAs - Most Common Reasons for Refusal?

    Posted 09-Aug-2017 19:13
    ​I'm also pondering what types of deficiencies could reasonably take more than 180 days to address.

    Clinical trial - Then resubmission and a second MDUFA fee are probably the least of your worries.

    Real-time aging study - ouch, unless you were clever enough to get it started before the original submission.

    Biocompatibility?  ISO 10993 Part 3 tests?

    Anything else that wouldn't be unique to a (probably complex) device that is likely to take more than 180 days?


    ------------------------------
    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


  • 10.  RE: 510(k) RTAs - Most Common Reasons for Refusal?

    Posted 29-Jul-2017 10:50
    ​​​Thanks, Mark.

    I share the perspective that, while turning it into a substantive review may be breaking The Rules, it's not going to get cleared without one, sooner or later, so not really a big deal, IMO, and, as Elizabeth has observed, sometimes a plus.

    Not enough data is somewhat the same thing, I would think, unless there is some reason that the RTA reviewer might be inclined to refuse a 510(k) for this reason, where the substantive reviewer would not, if these are two different people.  Otherwise, not enough data is not enough data, and you are going to have to address it, sooner or later.

    What I was sort of hoping for were some "no-brainers," like submitting test reports in a language other than English, that it would be easy to tell clients not to do, and reasonably straightforward for them to understand and implement.

    ------------------------------
    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


  • 11.  RE: 510(k) RTAs - Most Common Reasons for Refusal?

    Posted 30-Jul-2017 14:44
    I'll ask Beth Luoma for her thoughts...



    Sent from my Verizon, Samsung Galaxy smartphone



    Original Message


  • 12.  RE: 510(k) RTAs - Most Common Reasons for Refusal?

    Posted 26-Jul-2017 02:56
    I know there's one presentation from FDA because I used it as a baseline about a year ago to evaluate the RTAs at my previous company. I'll have a dig tomorrow to see if I can dig it up....

    ------------------------------
    Tina O'Brien RAC, MS
    Director of Regulatory Affairs
    Aroa Biosurgery
    Auckland
    New Zealand
    ------------------------------

    Original Message


  • 13.  RE: 510(k) RTAs - Most Common Reasons for Refusal?

    Posted 27-Jul-2017 02:59
    ​Great feedback...thanks, everyone!

    I was surprised to learn from Ginger Glaser on another thread that RTAs are still running at over 40% on the first pass.  I was around when they introduced Refuse to File for PMAs in the 90s, and after the first rough two years, everyone got their act together and the rate plummeted to less than 10%.

    The industry was less global then, so test reports were probably always in English.

    Once upon a time, there were FDAers who used to go to the Convergence and other meetings and present statistics on the most common deficiencies in 510(k)s and PMAs, don't know if anyone still does this.  It occurred to me that common RTA "deficiencies" might be a topic of interest for the Convergence, especially if the rejection rate is still that high, but I don't see a device session where this information would seem to fit.

    I never really thought of the RTA as an "administrative" review, but a review for "completeness," and sometimes that's a hard line to draw.  If the test report is there, but the reviewers can't read it, is it really "complete"?

    ------------------------------
    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


  • 14.  RE: 510(k) RTAs - Most Common Reasons for Refusal?

    Posted 27-Jul-2017 17:34
    ​This is a new presentation, but still helpful - medicaldeviceevents.com/wp.../03/10x-Medical-Device-Conference-FDA-RTA.pd

    I also review the MDUFA quarterly performance reports for 510(k) metrics to see how my submissions are tracking in comparison - MDUFA Quarterly Performance Reports
    Fda remove preview
    MDUFA Quarterly Performance Reports
    FY2017 MDUFA User Fees MDUFA Cover Sheets MDUFA Reports to Congress MDUFA Quarterly Performance Reports MDUFA Guidance Documents
    View this on Fda >




    ------------------------------
    Tina O'Brien RAC, MS
    Director of Regulatory Affairs
    Aroa Biosurgery
    Auckland
    New Zealand
    ------------------------------

    Original Message


  • 15.  RE: 510(k) RTAs - Most Common Reasons for Refusal?

    Posted 29-Jul-2017 10:22
    ​Thanks, Tina.  I've been looking for something more recent, because there should have been a significant learning curve since 2013.

    ------------------------------
    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


  • 16.  RE: 510(k) RTAs - Most Common Reasons for Refusal?

    Posted 29-Jul-2017 11:01
    ​Am posting this one again, as the first one didn't work for me:

    http://medicaldeviceevents.com/wp-content/uploads/2015/03/10x-Medical-Device-Conference-FDA-RTA.pdf

    ------------------------------
    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


  • 17.  RE: 510(k) RTAs - Most Common Reasons for Refusal?

    Posted 28-Jul-2017 06:59
    I have a couple of Associates, Beth Luoma  and Lisa Pritchard, who could teach a course on this topic.  Beth has spoken for Medical Alley on RTAs. If you go to our website, we have a Client Alert that Beth has written on the topic as part of our 510(k) series. Other than the administrative stuff, our biggest concern is when FDA turns it into a substantive review or decides when you don't have enough data when you may be able to convince management that you do under Least Burdensome requirements.  I hadn't thought of the perspective that it may buy you off the clock time to get your act together.  Good insight. Not always applicable but sometimes is.  

    Mark DuVal, J.D.,FRAPS
    DuVal & Associates, P.A.



    Sent from my Verizon, Samsung Galaxy smartphone



    Original Message


  • 18.  RE: 510(k) RTAs - Most Common Reasons for Refusal?

    Posted 29-Jul-2017 10:52
    ​​​Thanks, Mark.

    I share the perspective that, while turning it into a substantive review may be breaking The Rules, it's not going to get cleared without one, sooner or later, so not really a big deal, IMO, and, as Elizabeth has observed, sometimes a plus.

    Not enough data is somewhat the same thing, I would think, unless there is some reason that the RTA reviewer might be inclined to refuse a 510(k) for this reason, where the substantive reviewer would not, if these are two different people.  Otherwise, not enough data is not enough data, and you are going to have to address it, sooner or later.

    What I was sort of hoping for were some "no-brainers," like submitting test reports in a language other than English, that it would be easy to tell clients not to do, and reasonably straightforward for them to understand.

    ------------------------------
    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


  • 19.  RE: 510(k) RTAs - Most Common Reasons for Refusal?

    Posted 07-Aug-2017 18:49
    Julie,
    Here are some "no brainers" that will get you refused or dinged. Enough of them could get you refused
    - non-English sections
    - Lack of a table of contents
    - Lack of page numbers
    - Lack of required forms e.g. FDA cover sheet, cover letter, indications, 510(k) statement or summary and standards forms
    - If it's a device with special controls, treat the testing in the special controls like a checklist. Even if you don't do the suggested testing, I recommend a header with each suggested item. That way the FDA can quickly look through and see that you've addressed the required items. I usually recommend clients use the same terminology for testing as the FDA guidances and not their internal or ISO standard names.
    - Make sure the Truthful and Accuracy form is signed. Sponsors always forget this.


    ------------------------------
    Michael Nilo
    Network Regulatory Partners
    Nilo Medical Consulting Group
    Portland OR
    United States
    ------------------------------

    Original Message


  • 20.  RE: 510(k) RTAs - Most Common Reasons for Refusal?

    Posted 08-Aug-2017 08:49
    Julie, let me clarify and expand a bit (I know you've been communicating with Beth Luoma of our firm offline on this) that when FDA says in an RTA that a device has a different intended use or it needs a clinical study or human factors data based upon a draft guidance, it is inappropriate and we as an industry acquiesce to too much.  That allows FDA ti continue to ask for more and more when those issues may be negotiable.
     
    We have had over 750 clients and we are seeing the deleterious effects (and some good too) of the expansionist policies of the Shuren years.   I wish I could share with you the 200-plus times we got management to agree that some requirement was inappopriately imposed on our client or exceeds or distorted the definitional requirement, or asked for a quality or quantity of data that management later agreed was not Least Burdensome.  If we let the RTA stop us that would be bad for our clients.  We and other firms provided FDA a lot of feedback about the RTA, especially speaking at conferences about what were seeing and for the most part FDA has corrected things pretty well.
     
    But we must remain vigilant as an industry. I took 10 individuals to meet with Dr. Shuren early in his administration to share with them the impact the Agency was having on innovation and investment in innovation. The group was 3 CEOs, 3 VCs and 2 inventing physicians and one other from an organization we created of 150 CEOs and VCs called the Minnesota Medical Device Alliance.  We focused at that time on the 510(k) program but have provided insights more broadly over time.   

    Point is (and I know you are not saying this) some times its dangerous over time to go along to get along due FDAs regulatory creep.  We also understand its a balancing act and we advise companies not to argue over many things but to just go along because it's to expensive and time-consuming to argue about it.

    That's why we make docket submissions and file Citizen Petitions on behalf of industry.  We don't get paid for it.   A lot of our input is provided behind the scenes as others do.   We are just passionate about seeing this industry get treated fairly so it can survive and thrive!  

    Mark DuVal, J.D., FRAPS
    DuVal & Associate, P.A.



    Sent from my Verizon, Samsung Galaxy smartphone



    Original Message


  • 21.  RE: 510(k) RTAs - Most Common Reasons for Refusal?

    Posted 08-Aug-2017 19:59
    ​Elizabeth was kind enough to contact me, but she hadn't seen an RTA in recent memory, so she couldn't offer any other suggestions.

    I don't think there is a "we as an industry."


    ------------------------------
    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


  • 22.  RE: 510(k) RTAs - Most Common Reasons for Refusal?

    Posted 08-Aug-2017 19:40
    ​Thanks, Michael.  I don't think that TOC, page numbers, or cover letter are required in the regulation itself?  And now that "certain sections" of the RTA policy "may no longer be current" as a result of the Cures Act, the weight of the checklists seems somewhat ambiguous. 

    I have a client that wants to submit the minimum required.  When I look at the regulation, it would seem that the minimum is pretty...well, minimal.   This leaves them wondering why FDA decided their 510(k) wasn't "complete," when they think they included everything required by the regulation.

    ------------------------------
    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


  • 23.  RE: 510(k) RTAs - Most Common Reasons for Refusal?

    Posted 08-Aug-2017 20:09
    Julie, all of those are required by the guidance in the organizational elements section of the checklist https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm315014.pdf (Page 46).

    These are minor, but can be used as part of an arbitrary "totality of errors" used to reject the submission.

    I'm not sure how CURES will affect this checklist; however, I'd operate under the assumption that it's unchanged until an official notice is released.

    While I completely understand the request by the client, submitting the perceived minimum will usually lead to submitting less than the requirement, because something is always missing.

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

    Original Message


  • 24.  RE: 510(k) RTAs - Most Common Reasons for Refusal?

    Posted 08-Aug-2017 22:00
    Yeah, I already told them they will get an RTA, but in this case, that's the strategy. Still advising them to do the obvious and easy stuff.

    ------------------------------
    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


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