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Estimated time for preparing a De Novo

  • 1.  Estimated time for preparing a De Novo

    Posted 01-Sep-2017 15:09

    Hello RAPS members,

    Does any of you have an idea of:

    • How many hours does it take to prepare a de novo? (Just as a ballpark range based on your experience)
    • How many hours does it generally take to convert a 510(k) to a de novo in the event of an NSE?
    • What recent experience have you had regarding turnaround time on FDA review?

    Thank you very much in advance for your inputs.



    ------------------------------
    Maria Laitenberger, Jr. Eng., M.A.Sc., RAC
    New Zealand
    ------------------------------


  • 2.  RE: Estimated time for preparing a De Novo

    Posted 01-Sep-2017 15:35
    To develop a de novo from scratch I would say ~80 hours, depending on the information available.
    To convert a 510(k) to a de novo should take significantly less time since 90% of the information will already be organized, you are just changing the argument and possibly adding clinical data.

    De Novos have a statute of 120 days of review time; however, in my experience de novo's typically take about 11 months from submission to clearance. In the typical FDA answer "It Depends" on how complicated the device is and the reasons for the conversion from a 510(k).

    I'm happy to discuss more details.

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

    Original Message


  • 3.  RE: Estimated time for preparing a De Novo

    Posted 02-Sep-2017 04:52
    Hello,

    The total time for a denovo is about a year up to the reviewing time of the specific group in the FDA.
    More specific it take about twice as much as to prepare a regular 510k because there are two parts: the first one intends to reduce the regulatory classification to class II and once this has been reduces you need to submit something similar to a 510k except the fact that you don't have predicate device.


    ------------------------------
    Yoram Levy
    General Manager
    QSite
    Binyamina
    Israel
    ------------------------------

    Original Message


  • 4.  RE: Estimated time for preparing a De Novo

    Posted 03-Sep-2017 01:45

    Hi,


    On the question of denovo , is it true that the de novo fees (2018) have risen exorbitantly?  It mentions as De novo classification fees , is it the same as the application fees for submission ?


    Regards,


    Rashmi




    Original Message


  • 5.  RE: Estimated time for preparing a De Novo

    Posted 03-Sep-2017 11:47
    As always, "it depends"...in this case, on what you consider "exhorbitant."  There have been no fees, now there will be fees.  They are considerably higher than fees for a 510(k), but a lot less than fees for a PMA. 

    I share FDA's internal perspective that a De Novo is a "mini PMA," rather than a 510(k) with a classification review tacked on, so to me this seems quite appropriate.  Almost everyone I spoke with who has done a De Novo complained only that it took too long...because no fees means no resources to allocate to De Novos, and was looking forward eagerly for fees to be introduced.

    The direct De Novo is going to serve companies that want to develop very innovative devices, rather than "me too" devices.  Since innovation is where you find both the risk and the reward, the companies that want to innovate (and their investors) are ready to take the risk and won't flinch at the fees.

    I expect the De Novo to reshape the industry, the FDA, and our profession.  As these things always go, it will reshape it in a good way for some, in a not so good way for others.  I expect it will be very good for patients, as it has finally cleared the way for very innovative devices that are not high enough risk to belong in Class III.  I've waited for it my entire career, and am glad I lived to see the day.

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


  • 6.  RE: Estimated time for preparing a De Novo

    Posted 04-Sep-2017 07:13
    We do a lot of de novos.  The time it takes depends a great deal on your starting place.  If you start arguing for a 510(k) and really fight hard for it, you may win the day.  But sometimes you don't convince them and then you are on the de novo path (unless of course it is truly a PMA).  But even then your 510(k) arguments are not for naught since you've attempted to set the psychological hook for a Class II device and tried to make the data requirements commensurate with that with substantial equivalence, not reasonable assurance of safety and effectiveness.

    Sometimes you choose de novo out of the gate.  I try hard to get get the Agency to tip their hand early on so we can make an election what we want to pursue.  Sometimes I run things up the flagpole management to try to get their take or to influence them.  

    As for the fees, I argued publicly at the MDMA meeting inn Palo Alto that the user fee legislation now provides an economic incentive  for FDA to continue its trend to more narrowly interpret (definitionally) the 510(k) program and bounce them on to the de novo path. The panel agreed that could be an unintended consequence of the fee growing so dramatically.  It will continue to erode the 510(k) program which has been the plow horse of our device approval/ clearance process. 

    FDA does not like to be tethered to the data requirements associated with the 510(k) program, i.e. to establish the subject device is essentially the same as the predicate and does not diminish safety and effectiveness in comparison to it.  The de novo standard allows FDA to apply the PMA standard of reasonable assurance of safety and effectiveness instead of substantial equivalence.  This standard allows them fairly unfettered discretion to ask for what they want and they take advantage  of it.

    I agree with Julie, the de novo program is an important addition.  It is far better in many cases than ending up on the PMA path for many devices/companies.  I just don't want to see it emasculate the 510(k) program. Young reviewers and their Branch Chiefs too readily revert to it today.  We have a Client Alert on this topic on our website.  I speak at conferences/seminars lot at all sorts of meetings to challenge FDA's thinking/application of it.  I also raise it at in person client/FDA meetings a fair amount. We'll see where it goes.  

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

    Sent from my Verizon, Samsung Galaxy smartphone



    Original Message


  • 7.  RE: Estimated time for preparing a De Novo

    Posted 04-Sep-2017 09:50
    Yes, indeed.  The new user fee list now includes de novo submissions.  

    https://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFee/ucm573383.htm

    Unless you are have a Small Business Designation, you will pay $93,229 for a de novo classification.

    510(k)s jumped up, too, from $4,690 to $10,566.  There was a rumor around about fees for pre-subs, but nothing showed up on the 2018 list.

    Cheers,
    Melissa

    ------------------------------
    Melissa Walker RAC
    President & CTO
    Graematter, Inc.
    St Louis MO
    United States
    ------------------------------

    Original Message


  • 8.  RE: Estimated time for preparing a De Novo

    Posted 05-Sep-2017 03:16
    Fees for Pre-Subs are just a matter of time, part of FDA's insatiable desire to generate more fees for itself.  I'm astounded at the percentage increases in user fees, but the negotiation process is largely run by big companies.  MDMA does a good job fighting for smaller to mid-size companies.  We need to fight this trend because it is well known among the ranks who retire from FDA that user fees are not dedicated to approvals/ clearances as the law requires, but hard to audit and no incentive to do so. Many of those who have left the ranks of FDA feel they are over-funded because they have engaged in tremendous mission creep over the years and are well beyond the scope of what they are statutorily required to do.

    But always waving the banner of patient safety to justify more and more granularity in regulation, and holding industry hostage for an ever-growing percentage of their funding, has proven to be a brilliant political strategy.  User fees are a tax and the Agency should be funded by the general public, not industry. There is a segment of the public who believe its a conflict of interest and that may be true as it comes to large Pharma and medical device companies.  Big government, big business and big academia (who benefits from more studies, more science) get a little too cozy.  I say this even though I spent 17 years in big industry before starting muy own firm 14 years ago. I think the regulatory regime is increasingly being skewed toward large companies and not mid-size to small, to start-ups who innovate.  Now you've got me started ☺...

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







    Sent from my Verizon, Samsung Galaxy smartphone



    Original Message


  • 9.  RE: Estimated time for preparing a De Novo

    Posted 06-Sep-2017 07:30
    Mark,

    I completely agree. Only the big companies can afford to develop now, given all the requirements, infrastructure and fees needed. Kill innovation, sure.

    Ginger Cantor, MBA, RAC
    Centaur Consulting LLC centaurconsultingllc@gmail.com




    Original Message


  • 10.  RE: Estimated time for preparing a De Novo

    Posted 06-Sep-2017 16:41

    It's really not the size of  the company that matters.  If the device's postmarket value isn't worth the investment required to get through the De novo process, even the biggest company is unlikely to invest in it...although, that's not a given, because, for a big company, a number of factors can sometimes mix together in a way that makes developing a device worthwhile, even if the profits are unlikely to cover development costs.

    A small company can bring a De novo device to market if it can pursue a regulatory strategy that rolls out an initial version of the product in a minimally regulated space, and then use the profits from those sales to pay for further development to a De novo version.  But again, this only makes sense if the De novo version seems likely to generate enough profit post-market to warrant the investment.

    A small company can also bring a De novo device to market if the device has sufficient profit potential to attract investors to invest in it at the level needed to develop a De novo device.  But this is true of all devices, regardless of regulatory class or path to the market.

    The device industry has always been plagued by low profit margins because most of its products are commodities.  A novel device is the opposite of commodity, and therefore can often generate very high profit margins. These devices will probably not attract many of the types of investor that were drawn to 510(k) startups in previous decades, but they will bring in other types of investors, who have previously not found much to interest them in the device 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


  • 11.  RE: Estimated time for preparing a De Novo

    Posted 07-Sep-2017 04:17
    Yes and the said thing is we have 3500 or more 510(k)s per years and 22, if we are lucky, PMAs.  Innovation, for the most part happens incrementally, not in PMA-like leaps.  The 510(k) program is the engine of the medical device economy.  Seventy-five percent of our clientele are pre-revenue, start-up or small companies who come to us from CEOs, VCs or VPs of reg and they are not getting funding as in the past unless it's angel investors.  The rest of our clientele is mid to large size companies.  Fortunately the strategics are investing a lot in these company's, but not early stage.  

    Mark DuVal, J.D., FRAPS

    Sent from my Verizon, Samsung Galaxy smartphone



    Original Message


  • 12.  RE: Estimated time for preparing a De Novo

    Posted 07-Sep-2017 15:51
    I'm hoping to see more like 2500 510(k)s and 1000 Denovos in 10 years, but time will tell.

    I agrwe that incremental change is most common, but that's not the kind of change that breathes new life into an industry that has reached maturation/consolidation.

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


  • 13.  RE: Estimated time for preparing a De Novo

    Posted 08-Sep-2017 07:13
    But just as important to society is that 510(k)s is that newer  better versions of existing devices bring prices down Ann's make them more more affordable by a breaking health care system.  That one of the very advantages of maturation.  But if FDA makes out too difficult and expensive for that too happen we can't enjoy the benefits of that maturation.  

    Mark DuVal, J.D., FRAPS


    Sent from my Verizon, Samsung Galaxy smartphone



    Original Message


  • 14.  RE: Estimated time for preparing a De Novo

    Posted 08-Sep-2017 21:23
    Yes, but newer doesn't equal better, and the 510(k) standard isn't better, its SE.

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


  • 15.  RE: Estimated time for preparing a De Novo

    Posted 07-Sep-2017 04:04
    Totally agree Ginger.  Big companies have unwittingly become an innovation killer because they acquiesce to so much to FDAs ever-growing data requirements and have the financial wherewithal to do so.  Yet most big companies acquire technology. Rarely is it organic any longer.  

    Mark DuVal, J.D., FRAPS

    Sent from my Verizon, Samsung Galaxy smartphone



    Original Message


  • 16.  RE: Estimated time for preparing a De Novo

    Posted 06-Sep-2017 16:04
    ​I think all of this has been a foregone conclusion for decades, and reflects the simple truism that the US can't afford FDA (and a lot of other things) any more, if it ever could. 

    Kefauver Harris was passed in the heady post-WWII economy, when the US was so flush, it was able to build an entire interstate system without raising taxes one dime.  Things were still looking good when the SMDA were passed in 76.  But the politicians and other magicians have run out of ways to stave off reality.

    It seems a given to me that FDASIA was predicated on the assumption that fees would soon go sky high, and with the tacit support of some part of the industry that saw it as being to their benefit.  Most likely, FDASIA marks the point in the industry's lifecycle where certain companies were now ready to go forward on a "pay to play" basis.  They had to know that Congress would never provide FDA the resources, and taxpayers would never be willing to pay the taxes to support the level of oversight with which FDA has now been tasked, and all the "risk-based" oversight in the world can only stretch a an ever-thinning dollar so far.

    ------------------------------
    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: Estimated time for preparing a De Novo

    Posted 07-Sep-2017 04:06
    Very well said Julie! 

    Mark DuVal



    Sent from my Verizon, Samsung Galaxy smartphone



    Original Message


  • 18.  RE: Estimated time for preparing a De Novo

    Posted 07-Sep-2017 16:00
    While in sure most of the old-timers will just mentally correct my error and read on, but, knowing a lot of newbies are studying hard for the RAC right now, I feel the need to say sorry for any confusion, and you are correct, it was not the SMDA, but the original Medical Device Amendments that were passed in 1976.

    ------------------------------
    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: Estimated time for preparing a De Novo

    Posted 08-Sep-2017 09:14
    Actually, MDMA was part of the industry during the MDUFA4 negotiations. AdvaMed also has a big small company membership under their Accel program. However, the big reason they are not heard more is time and priority. Big companies often have a very experienced RA pro whose main job is to participate in trade association work and serve on committees like MDUFA negotiation. Small companies MIGHT have one VP who also wons operations, perhaps some other functions, fund-raising etc.

    In this last round, there were exactly 2 of us representing small companies on the AdvaMed side that raised concerns throughout the process (remember that many, including the President, wanted the total $$ to be bigger). I hear it was similar in MDMA. Luckily, I happen to have a CEO who "gets" why small companies need to be more active and let's me make it a priority. Others are not so lucky.

    g-


    ------------------------------
    Ginger Glaser RAC
    Vice-President, Engineering
    MN
    ------------------------------

    Original Message


  • 20.  RE: Estimated time for preparing a De Novo

    Posted 08-Sep-2017 21:19
    This is a common phenomenon that extends far beyond FDA, industry, and the federal government. Squeaky wheel as low-hanging fruit.

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


  • 21.  RE: Estimated time for preparing a De Novo

    Posted 02-Sep-2017 19:21
    Maria,

    Under FDASIA 2012, we (industry) have another option to go for a de novo.

    It all depends on your prior communication with the FDA regarding your pending 510(k) without a predicate.

    You may submit a 510(k) with de novo petition at the same time if you have engaged in communication with the FDA prior to your submission.

    You also may submit a de novo petition after obtaining an NSE letter.

    As for timeline, it ranges from 10-24 months of time.

    For putting a 510(k) and petition together, it would range from 100-200 hours of time depending upon complexity. If quality review is enforced/implemented, additional hours should be added. 

    Thank you.

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    REGULATORY DOCTOR
    Phone (Toll-Free): 1-(800) 321-8567

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.





    Original Message


  • 22.  RE: Estimated time for preparing a De Novo

    Posted 03-Sep-2017 13:45

    Under the Paperwork Reduction Act, all Federal Agencies must submit specific information to the Office of Management and Budget for approval.

     

    FDA-CDRH recently issued a guidance document on accessories, and explained that the de novo process would apply to new accessories. The guidance document provide the OMB control number 0910-0823 which expires September 30, 2019.

     

    FDA estimates it will receive 8 accessory classification de novo requests requiring an average of 180 hours per request including:

    The time to review instructions

    Search existing data sources

    Gather the data needed

    Complete and review the information collection

     

    It does not state the time period over which it expects to get the 8 classification requests. In addition, I don't know if an accessory classification request would be shorter than another type.

     

    It appears that the analysis FDA provides to OMB is the mean, but they don't provide any other information about the expected underlying distribution. I expect that they are skewed with a long tail to the right.

     

    In my experience looking at other FDA submissions to OMB, FDA seems to underestimate. If I recall correctly they estimate one hour for each MDR and 15 hours per year for a device manufacturer to perform supplier management.

     

    I don't know the de novo fee for FY17, but for FY18 the standard fee is about $93,000 and the small business fee is about $23,000. See https://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFee/ucm573383.htm

     

     



    ------------------------------
    Dan O'Leary
    Swanzey NH
    United States
    ------------------------------

    Original Message


  • 23.  RE: Estimated time for preparing a De Novo

    Posted 03-Sep-2017 18:58
    Hi Maria:

    My experience would say that 80 hours is for a not-too-complex product with not big scientific issues. The answer can be a "how long is a piece of string" question. The issues I have had were around documentation from different jurisdictions needing to be re-worked to match the labeling etc being submitted to FDA: a slight change to the wording of an indication and contraindication can lead to new risk analysis, design inputs and hence eventually (software) verification and validation, which alone could easily blow 80 hours.

    FDA would encourage you to do a pre-sub first ... but if they have issues from left field, you may not know the questions you should be asking prior to the initial submission and allowing for a Q-sub might be prudent. As a rule of thumb I would say allow at least 40-80 hours for responding to questions on top of the initial submission.

    So to sound a note of caution, I would be prepared for a very time consuming process, in which the initiasl submission can fade into insignificance.

    Good luck!

    Neil

    ------------------------------
    Neil Armstrong FRAPS
    CEO
    MeddiQuest Limited
    Peterborough
    United Kingdom
    ------------------------------

    Original Message


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