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  • 1.  PMA and 510(k) benefits

    Posted 02-May-2020 17:27
    Dears,

    I have a question concerning the PMA and 510(k) process.

    If I understand correctly, FDA cleared is something that allows me to put my device on the market, FDA approved is something which proves my device, it is safe.

    Just hypothetically, the device has the same indication for use, but intended use is noninvasive compare to the equal device, which is invasive. The equal device is used in the hospital. I want to put my device to home care. The equal device is 510(k) cleared. I have clinical evidence, data from the clinical trials. Can or must I apply PMA? Does it give me some benefit? For example, if something happens, I have a strong argument that was user error because I am approved, and FDA checks everything? Can I apply DeNuovo, and I will still be approved? Or does not matter, I can (must) use 510(k) because it is not a high-risk class? What happens if I put there artificial intelligence for changing treatment? Is it such novelty I have to apply PMA?

    Thank you very much

    Regards

    Lukas Peter



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    Lukas Peter, Ph.D.
    VSB-Technical University of Ostrava
    Czech Republic
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  • 2.  RE: PMA and 510(k) benefits

    Posted 03-May-2020 07:41
    Hi Lukas,

    In my view point whether a device is cleared under a 510(k) or approved under a PMA - FDA always ensures during it's review process that the device in question is safe and effective.
    Submission route will depend on the product classification. So you need to zero down if your product is a class II or a class III device. 
    If you are not sure - I highly recommend to submit a pre-sub to FDA presenting which submission route you think is right and why and what FDA thinks about it. 
    Though the two devices (subject & 'equal' device) have same indications for use, however, you need to evaluate what new questions of safety and effectiveness are raised when the use environment (Hospital to home care) is different.

    Regarding PMA & De Novo Pathway - the below link beautifully describes why Industries choose one pathway over the other.

    https://www.greenlight.guru/blog/de-novo-pathway-medical-device-companies

    Thanks!

    ------------------------------
    Meenakshi Verma
    Regulatory Affairs Professional - Medical Devices
    Ontario
    Canada
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    Original Message


  • 3.  RE: PMA and 510(k) benefits

    Posted 04-May-2020 04:20
    Lukas,

    Any device FDA reviews is from the aspect of safety and efficacy, regardless whether this is a 510(k) submission or PMA submission.

    Also you can not choose whether you submit a 510(k), De Novo, or PMA application.  This is all based on the regulatory classification of the device, use of a Product Code, and whether a predicate device is available.  From the FDA's database you can look up a product type, find the regulation, and will provide the classification, i.e. Class II or III.  It must be clear getting a 510(k) Clearance or PMA Approval does not constitute a "seal of approval" for your device on the market.  It is still up to your organisation to place safe and effective products on the market.  User error has nothing to do with FDA clearance or approval, it is still your device and you are still responsible.  If you are not clear about the regulatory pathway you should seek help from a subject matter expert or through the Q-Submission program with FDA.

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: PMA and 510(k) benefits

    Posted 04-May-2020 08:48

     

     

    Hi Lukas,

     

    Here are a few additional thoughts for you on PMA vs 510(k). 

     

    In approving a PMA, FDA is making a determination that sufficient evidence exists to provide a reasonable assurance of safety and effectiveness (not efficacy).  In clearing a 510(k) the finding is substantial equivalence (technically, it's a classification decision), but practically speaking the review is to assure safety and effectiveness is equivalent to (no worse than) the predicate device.

     

    I agree with the previous comment that you don't get to pick the pathway--FDA will have the ultimate say.  Though you can propose an atypical approach (if you have good rationale), it is not at all common to succeed.  That said, I can advise I've been able to get a device cleared under 510(k) where the similar marketed device had a PMA.

     

    Even if the similar marketed device got to market by way of a 510(k), you may need a PMA depending on desired claims.  For example, if you wish to claim your device provides a very specific clinical outcome, it may drive it into a PMA process.  On the other hand, claims of greater benefit may be a marketing advantage over competitor devices with less meaningful claims.

     

    There are other basic differences in terms of substantially greater user fees for a PMA, as well as a greater degree of evidence needed to support the review.  The PMA has annual reporting requirements (with more user fees), and the company has less latitude to make modest changes.  These factors can also add up to marketing advantage in terms of barriers to entry.

     

    Finally, having an approved PMA generally provides a benefit over 510(k) clearance in that it provides considerable protection from liability; specifically, many potential plaintiff claims are explicitly preempted.  Courts have often held up similar protections for 510(k) cleared products, but the case law is more varied and much less clear.

     

    Hope that's helpful!

     

    Best regards,

     

    Ted

     

    --

    Theodore (Ted) Heise, PHD, RAC

    Vice President Regulatory and Clinical Services

     

    MED Institute Inc.

    1330 Win Hentschel Blvd.

    West Lafayette, IN  47906-4149 USA

    765.463.1633 ext. 4444

    http://medinstitute.com

    theise@medinstitute.com

     

     

     

     




    Original Message


  • 5.  RE: PMA and 510(k) benefits

    Posted 05-May-2020 07:03
    Lukas,

    To the many fine points posted by others, let me emphasize a few points.

    As many others have stated, you don't have the luxury of choosing your regulatory pathway absent a clear reason.  You stated that the equivalent device is a 510(k) device.  FDA may consider home care without a PMA provided there is adequate labeling and user features to prevent intentional and unintentional misuse.  FDA may also consider this a de novo because it is a new application (not indication) of an existing technology, but as others have stated this is equivalent to a 510(k) clearance, not a PMA. 

    PMA protection from competitors carries with it a high overhead of initial PMA cost, PMA supplements for changes, and annual reports.  All come with a cost, particularly PMA supplements which often require manufacturing of "production units" for V&V which cannot be marketed until the PMA supplement is approved.  This oftentimes means maintaining both the "old" and "new" production lines.  This is a tremendous overhead requirement not associated in most cases with a 510(k).  And again, the manufacturer usually cannot make this decision.

    You are located in the Czech Republic, so obviously the distinction between a PMA or 510(k) does not apply in your geography, but only in the US.  Case law in the US may be persuasive in other jurisdictions, but is certainly not binding (and vice-versa).

    Please keep in mind that the liability protection that you infer to manufacturers who market a PMA product does NOT mean that everything is user error because FDA checks everything.  The US liability protection for PMA-approved devices only covers devices that rigorously conform with the manufacturing processes and performance specifications of the PMA (Medronic v. Lohr, 518 U.S.470(1996), Reiter v. Zimmer Inc., 897 F.Supp 154 (S.D.N.Y.1995)).  In short, the PMA liability protection only applies to preventing product liability lawsuits under the tort (or liability) laws of individual states, and then only if the device cannot be shown to be adulterated under the FD&C Act (i.e. PMA or GMP violation).  A medical device cleared under the 510(k) statute has no such protection against state law product liability suits.

    You have a number of questions, I would certainly recommend a Pre-Sub, but be sure to propose answers to your questions.  As many posters have stated, FDA is not a consulting firm and they expect you to come prepared.

    Regards,
    James

    ------------------------------
    James Bonds J.D.
    Director Regulatory Affairs
    Atlanta GA
    United States
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    Original Message


  • 6.  RE: PMA and 510(k) benefits

    Posted 04-May-2020 09:23
    These are good questions Lukas, and you are headed to assessing the right trade-offs. For instance, having a PMA gives you "pre-emption" from certain liability lawsuits in the US, whereas a 510(k) does not, as FDA has not explicitly deemed a 510(k) device "safe and effective." Generally, you don't get a lot of "say" in which pathway you follow - if there is a Class 1/2 "rule" that applies, you follow the 510(k) path, if there is a Class 3 category you follow PMA. Devices that don't fit smoothly into a category are either PMA or de novo. De novo, like with a 510(k), is NOT an FDA approval, but a marketing authorization like a 510(k).

    The situation you describe though, may indeed fall into an area where you might get some ability to influence the classification - does home use raise significant enough "new safety and effectiveness issues" to warrant moving to a PMA? I'd say generally changing site of use doesn't change the regulatory pathway, but a device may have unique issues that would cause it to - for instance "home use surgical tool" could very well raise enough S&E issues to make it viable to be Class 3.

    Generally if you have a preference, it is a good idea to make your argument in a pre-sub (and/or 515(g) submission) and see if FDA agrees. FDA may already have "decided" that certain things - say artificial intelligence - fall into a certain pathway and you'll know sooner than later.

    Ginger

    ------------------------------
    Ginger Glaser RAC
    Chief Technology Officer
    MN
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    Original Message


  • 7.  RE: PMA and 510(k) benefits

    Posted 06-May-2020 11:41
    From a clinical perspective, nothing will make your medical device "safe" as this word is defined in a dictionary. 

    Different jurisdictions will adopt what are essentially legal definitions of this word. Devices that meet this definition are "safe" only within the scope of that definition, which is more than just the words, but also includes the process the regulatory agency follows to determine whether the device meets that definition.  Two different jurisdictions may adopt the same literal definition, but follow different processes.  For example, one may require one kind of data to demonstrate "safety," and the other may require some type of data...perhaps data from a clinical trial versus data showing conformance to a standard.  Some might review the data premarket, some might not.  Medical devices deemed "safe" in one such jurisdiction might not be deemed "safe" in another.

    As others have noted, you don't get to choose your regulatory path.  In some borderline situations, you might be able to steer it down one path versus another, but if FDA doesn't buy it, then your device cannot be legally marketed in the US unless it follows the path FDA thinks it should follow.

    Essentially two things determine the US regulatory pathway for a medical device: 
    1) the level of risk it poses to patients determines whether or not it must be approved via a PMA.
    1) If it does not require a PMA, then whether or not it has a predicate determines whether or not it can be cleared via 510(k).
    3) If neither of the above, De novo.

    In the US, you are legally permitted to advertise your device as "approved" only if is marketed via a PMA. This is probably the main benefit of a PMA, but, again, you don't get to choose to get a PMA approved just because you want to advertise your device as "FDA-approved."   In addition, if someone wants to market another device like yours, they will have also have to get a PMA approved and also spend as much time and money to get it approved.  I wouldn't call this a benefit so much as maybe some consolation.

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

    Original Message


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