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  • 1.  A new 510(k) vs. Special 510(k) vs. no new 510(k) for acquired assets

    Posted 16-Jan-2017 14:42

    Hello all.  I have a question regarding an acquired product/company that I wanted to get some board input on.  I've gotten a lot of conflicting info, so perhaps the board can provide a little clarity (or not).

    The Background: I started a medical device company (NewCo) that acquired the assets from a medical device company (OldCo) who obtained 510(k) clearance for one product and generated some market sales in the U.S.  Before we (NewCo) acquired the assets, OldCo had some GMP compliance gaps that lead them to eventually receive a Warning Letter.  OldCo voluntarily closed down to address the GMP compliance gaps.  This is were my company, NewCo, comes in - we bought OldCo assets (including 510(k)) with the intention of correcting the deficiencies and "re-launching" the device.  

    The Situation: The 501(k) from OldCo on the old device is valid - no injunction was placed on the device clearance as part of the WL.  As part of the fixing the GMP gaps, we are also making some updates to the design for business reasons (higher quality materials, enhance features, etc).  My plan is to show that these design enhancements do not impact safety, efficacy or intended use and document this in the DHF.  Therefore, no 501(k) submission is needed.  I would simply register my company as a specification developer and link the OldCo 510(k) number (note: the OldCo name is still on the 510(k)).

    The Confusion: Several of my regulatory colleagues (and some investors) think that this approach is wrong, in that I have to re-submit a 510(k) regardless of the situation.  Even if the new design does not impact the safety, efficacy and intended use.

    What are the board's thoughts on this?  Can I use the OldCo 510(k) in this situation? And if not, will a special 510(k) be more appropriate?

    Any insights would be greatly appreciated!



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    Christopher Wilson RAC
    Chicago IL
    United States
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  • 2.  RE: A new 510(k) vs. Special 510(k) vs. no new 510(k) for acquired assets

    Posted 16-Jan-2017 22:18
    In late December 2014, FDA published a draft guidance entitled, “Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers,” which provides information to industry on how to notify FDA of the transfer of a 510(k) clearance from one person to another. The draft guidance also outlines procedures that FDA staff and industry should use to ensure that public information in FDA databases (such as the database of 510(k) premarket notifications) about the current 510(k) holder for a specific device is accurate and up-to-date.

    http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm427385.pdf

    Only one person may hold a 510(k) clearance at a time. In the event that more than one person claims to be the 510(k) holder for a particular device at the same time, FDA’s database will show the person who listed the device most recently as the 510(k) holder until the issue is resolved. Although the draft guidance provides only minimal detail about the dispute resolution process, the draft guidance indicates that the agency will contact both persons claiming to be the 510(k) holder and attempt to determine the rightful holder.

    I hope this helps.

    John Beasley, RAC (US)


    Original Message


  • 3.  RE: A new 510(k) vs. Special 510(k) vs. no new 510(k) for acquired assets

    Posted 17-Jan-2017 06:57
    I think that the recommendation from John addresses the transfer of the 510(k) to NewCo quite well.  However, you mention that you are making some design changes, including materials and "enhance features".  You should carefully consider the draft guidance "Deciding When to Submit a 510(k) for a Change to an Existing Device", because changes in materials and user interface are specifically called out as items to be considered when making a design change.  The risks associated with these changes need to be evaluated before a statement of no impact on safety, efficacy, or intended use can be made. 

    If after that analysis, documentation in the DHF is appropriate, then do so using the draft guidance as a guideline.  No new submission would be required in that case.  If a submission is necessary, a Special 510(k) may well be appropriate and possible because NewCo will now "own" the existing 510(k).





    Original Message


  • 4.  RE: A new 510(k) vs. Special 510(k) vs. no new 510(k) for acquired assets

    Posted 17-Jan-2017 07:41
    Hi Christopher,

    If the device did not change enough to require filing AND there has not been creep in intended use/indications for use , as reflected in advertising and claims then in my opinion, no filing is required. But you really should do a thorough assessment of all changes. You should also determine if the device is under performance standards or special controls which may have come into effect since the original 510(k). If so,  determine if the device meets them, or needs changes to meet them and if so, evaluate if those changes require a filing. 

    Consider the risk management analysis and what has been seen on PMS.  If it has software, you should review FDA's guidance for changes to software in devices covered by 510(k)- related to corrective versus adaptive changes and evaluate if a 510k needs to be filed.

    I guess you have to deal with UDI most likely now too.

    I have done this analysis for other companies acquired. If you need more, feel free to private message me.


    Good luck!


    Ginger Cantor, MBA, RAC
    Owner/Principal 
    Centaur Consulting LLC
    715-307-1850



    Original Message


  • 5.  RE: A new 510(k) vs. Special 510(k) vs. no new 510(k) for acquired assets

    Posted 17-Jan-2017 09:05
    Hello Christopher,
    You have come to a good place for input. You can reasonably expect helpful comments from several experienced professionals.

    • The sale of OldCo to NewCo along with property rights to the device in question does not in any way imply a new 510(K) is needed.
    • The fact that the device itself was not implicated by FDA in the warning letter to OldCo does not, by itself, indicate that the clearance of the new device is valid. In the purchase of any company with regulatory issues, a diligent approach would suggest a careful review of the troubles and their wider impact is warranted.
    • Changes to the device (better materials, enhanced features) as well as its labeling, manufacturing and indications for use/intended use could all require another 510(K). Please do not be offended, but your use of the word "etc." in your question suggests a certain naivete. The only way to reach a firm conclusion is to do a formal written analysis. The formal analysis is standard practice in the device business and is FDA's expected minimum.
    • If NewCo is the current owner of the device it should update its device listing with FDA to show this. If the device is temporarily not on the market it can make this change at the time the product is relaunched.
    • Registering NewCo with FDA as a Specification Developer may be appropriate if they will engage in design only and perform no other manufacturing (including intermittent packaging, labeling or service).
    • Special 510(K)s are only acceptable when design controls are fully implemented and the indications for use for the new device and the old device are identical.
    Good luck on the final resolution of your questions. Feel free to contact us privately if you would to discuss your questions further.

    Kind regards,

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    David Ledwig, RAC, CQA Principal Consultant Practical Compliance, LLC ledwigd@practicalcompliance.com O (828) 862-8555 M - (828) 508-6535
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    Original Message


  • 6.  RE: A new 510(k) vs. Special 510(k) vs. no new 510(k) for acquired assets

    Posted 17-Jan-2017 09:55
    Changes to devices may prompt a new 510(k) submission and that will depend upon the change itself, the results of the validation studies, and how much the change *may* affect safety and efficacy. Material changes may provide significant enhancement to features of a device while at the same time engendering additional performance specifications or contraindications. Perhaps this requires clearance through a special 510(k)? The guidance below has useful flowcharts and change-type information that may be valuable to you. Note that many changes require documentation to a DHF and not a new submission. 
    Also - if the OldCo made changes to the device that were simply documented in the DHF, the additional changes that NewCo makes may put the device far afield of the predicate and although one change, for example, may not need be cleared, the summary of all changes may. 

    Is a new submission necessary: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080235.htm 

    Types of 510(k) submissions:  http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134034.htm

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    Holly Bilinski, MS, RAC Ann Arbor, MI United States
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    Original Message


  • 7.  RE: A new 510(k) vs. Special 510(k) vs. no new 510(k) for acquired assets

    Posted 18-Jan-2017 04:32

    I think there is some excellent regulatory advice above about the options you have. I would challenge you though to think about the longer term: do you have an exit route from NewCo (will you ever sell it) or seek to raise funds? There is real value to purchasers and investors in having a clear regulatory baseline at the start of a new company that would be achieved through a new traditional 510(k): ownership of the new 510(k) would be clearly part of the equity of NewCo, there would be no did to dig back into OldCo's history to find correspondence with FDA and old letters to file and it would free the NewCo from any of the associated regulatory baggage.

    As someone who frequently is asked to conduct due diligence on aquisitions, disposals and investments, having a clear regulatory baseline at the start of a new business will at least smooth the process and can add to the value of NewCo. It sounds to me like your changes (additional functionality) could require a new 510(k), particularly when coupled with address, name, labeling changes for NewCo and any prior changes since the last submission. So I would suggest biting the bullet and seriously considering a new 510(k) because of the long term benefits.

    FYI One of my customer's is currently through a their garage for bankers' boxes of old records for correspondence with FDA from a long closed company - he has already spent much more time doing this in the last two months that he would have taken to write a 510(k) and establish the baseline for the new company.

    Whatever you decide - I wish you good luck with the new business!

    Neil



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    Neil Armstrong RAC FRAPS CEO MeddiQuest Limited Cambridgeshire United Kingdom
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    Original Message


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