years yet the district court concluded the congress unambiguous the foreclosed the f t s discretion treat this product as a drug that was incorrect for two reasons one that applies to the regulation of all products and one that plea limiting the drug death but that assumes congress could only have meant for the drug and device definitions to be mutually exclusive and in fact there is no reason to believe that the statute used to contain language excluding devices from the definition but congress removed that language thirty years ago the current text of the drug definition plainly encompasses the device and the statutory structure and purpose provide no basis to read into that the drug ask your letter says that it appears that this silk solution is a device i have a hard time seeing how it's a device i realize that that's not an issue that you all have raised but there is plenty of precedent for us to consider into and ultimately dispositive of the dispute for it even if the parties fail to identify and brief the issue and as i say i just have a hard time seeing that this oral solution is a device what does it fall under that it's not an instrument it's not an implement a machine an implant in vitro reaction it's not even an apparatus or what that is whatever that means and you're left with an article and i realize that every drug is defined in terms of being an article still let me let me in its guidance is that that language doesn't play much of a limiting role in the reason frankly is that there's just such a broad diversity of products that many thing right you wouldn't think of as you know machine contrivances cetra are properly classed as devices so for example in an example given a solution that is used to clean up in you know surgical instruments or something like that could be a device even though you wouldn't think of it as a three opinion if we say well we'll debate the same assumption that this is both a device and an a drug when at least i think it doesn't qualify as a device to begin with and so in other words the question before us is just does the f d a have the discretion when it's both a device and a drug to treat it as a drug and my question to you is is part of what sets up the scanning technology to actually function and so it could be a plausibly a device but but it also led me to be somewhat surprised by the f d a is position that the drug definition wholly subsumes the device definition because it seemed to me with some of the other  references in the prefatory definite prefatory phrase of the definition of device there are going to be implements machines apparatus i that because they are so clearly those application of the specific predominating over the general with respect to the exclusion with respect to the definition of a device it seems to me more plausible and more straightforward that what is more narrowly and in the device definition might in fact bring things decisive of the categorization for at least a number of devices but that's not the  drugs correct correct ron and so then let's talk about statutory doctor statutory structure as i understand it is all drug must go through a very elaborate approval process under one part of the statute that's done by one part of f d a vices have to go through a very different approval process that stop by a different part of f d a and nobody thinks that some particular structure is if if if drugs then you're on track one but not track two if device you're on track to but not track one and the device circle is wholly within the drug circle and you have your us knowledge that this can't be rationally read to require both and then you treat the statutory structure which says if the definition has all of these mandatory consequences associated with that product you read that as saying well now the f d a in fact has choice to pick whether to treat something as want one is supposed to the other so i disagree in a couple of way through our st i don't think any of the mandatory consequences your honor reference follow from the fact that something fall determines that the product is to be regulated as a device i don't think the statute the drug fireman's apply so if something were cosmetic and also a drug the f d a would have discretion to put it through the much device context is also perspire lodges as well so it is commonplace in this regulatory scheme for products to fall within you know multiple broad you know regulatory headings and so the f d a exercising discretion given to it by congress to decide which athlete so everything that's a tobacco product is everything that's a modified risk tobacco product is also tobacco product kind of by definition so if the f d a wanted to it could just question is what you can do under your interpretive theory and if on the venn diagram if the circle for devices is entirely within the larger circle for drugs and your theory is that any any particle that satisfies both which is everything in the smaller circle you have discretion to treat as either what follows is you have discretion to treat every device as a drug and not just makes nonsense out of the statutory structure which is one ridiculous a good scheme for drugs and view and i guess to me what's and maybe we should move to the argument that's actually made which is not about the predicate clause in the medical device definition but about the exclusion it seems to me there even if you were more receptive to the questions that we've been asking about the protocol is that it in fact specifies some category of things that are devices that can that don't also fall within the drug definition because of the operation of their additional specificity so because of the operation of the cannon that the specific governs the general even if you accept that then it seems to me the that that the district court applied the same reasoning to the exclusionary cause and i'm not sure that it necessarily follow so the exclusionary clause is excluding roughly things that are must have allies or functions or chemical reaction and it says those are not devices and as i understand it what the district court did was say ok if they're not devices that means their drugs and that means that something that is not that that means that that is part of the the drug definition and something that does not fall within that a exclusion therefore necessarily is not a drug and those further implications seem to me not necessarily to follow from the the specific government the general and i just wonder and let me just add one more thing that might make that clearer so the fact that it's not a device might imply that it's a biological or that it is food not that it is necessarily a drug because it's multi polar stach just not a bipolar statute and i guess i'm just wondering whether you agree that it's a narrow way to look at your position than the one you've marked out where all devices are also drug so under our view if a product satisfy have a broad provision any general in a specific provision line side by side so that reading the broad provision as applicable would read out of the statute the specific provisions so for example in fork oh you have a broad general venue the narrow happened specific venue statute and supreme court said well if you could apply the general then you statute in after case that would be no quaint to the patent specific venue statute but again neither of those is present here there is nothing  otherwise has full discretion over so the only non discretionary sorting as between the category of drugs and devices is that which is accomplished by the exclusionary clauses that it's right and i what i do want to make sure i spell but under your view of the statute you could change those regulations there would have to be a non arbitrary or capricious reason for doing so that did not undermine the broader two  think if f d a exercised its authority in any of the extremely broad ways that have been posited it would it would violate the statutory scheme what it is doing here is exercising the authority as to a limited category of products where there are good reasons consistent with the statutory scheme for treating the category of products to barely could make a plausible argument in any case you want the article satisfies the definition of drug a drug regulation is more stringent you care you rightly character a deal about safety and efficacy and you think it's important to have more stringent rather than less stringent regulation for some category of thing about which you have a concern and i don't think that would be consistent with the statutory scheme congress didn't create these as you know more and less the limiting principle in terms of your the extent of your authority to reclassify or to categorize within the within that smaller circle the limiting principle is that the f d a the presumption is that something  to exercise discretion the presumption in agency practice which i think follows so if f d a is going to override that presumption follows from the statute that just sounds like an elliptical way of lead and phrase as if they really just reduced article but then you're circling back and and that's sort of for purposes of like your jurisdiction over you know which which track you're  already to assign them to one track or another and but then you it seems like you're sort of bringing back in those more specific terms as a guide for your discretion than another words you know could you take crutches which are you know an implement and say well there are drugs they're an article and they're meant to be you know curative ever you know help people and getting over a malady or can we take x ray machine regular as a drug and you know at some level oh it's an article but so is that right that you're sort of on the one hand rejecting that initial language on the other hand finding it to still have a bearing on your discretion so your honor that the reason crutches are to use my micro temple and aides couldn't willy nilly be regulated as a drug is not i think it is a thing that goes clank it's that there is that are really resonate with common sense about devices should just be taken out there or there are a left over and of another figuring out how to write that how to write it in a broad way to encompass a lot of things that don't seem to go clank like and may be an in vitro religion and you're just they could have just liquids used to clean surgical instruments the other the other reason is that there are there are consequences to being able to call something that that have to do with parts of the statutory scheme other than the one we're talking about today so to give an example if someone to morrow tried to introduce a little metal box that with the claim that if trees cancer and the f d a wanted to prevent that obviously fraudulent device from being sold to the american favor specifically with respect to contrast agents which is that in the two thousand and seventeen amendments to the statute legislated in a way that pretty clearly accepted as permissible the f d a is then twenty year old policy of treating all pathway for approval of the device as a device and that's a pretty good indication is this court has recognized in many cases that congress approves the f d a as permissible so even if the court is disinclined to reach the drugs play is if any so i you know i may be misunderstood but i don't think there is a any import to any characterization contrast agents as i buy those don't do that or should which it could easily have done you right although it may be that those with an interest in this issue simply weren't at the table well i don't think that's accurate the question the judge henderson started with which is how can this device how can this medical product be a device and it will also answer i think some of judge pl ards concerns about whether something could be a food or a cosmetic a drug there is a threshold determination that is made used in the intended use portion of the medical device definition in and of the drug definition that if the product is in his hand to be used in this case for the assistance in the diagnosis of the disease it is a medical product so if a if a product is intended to be used to not to treat a disease it can be a food but if it's intended to be used to diagnose treat shore a disease or prevent a disease then it's a drug and a drug or a medical device depending on the nd step of the analysis all d biologics are drugs so there's no separation between those biologics are a subset of drugs and that's made clear in the statute and in the regulations the nd step of the process once a product has been determined to be a medical product is it a drug or is it a device the device definition is judge katz this was explaining and  is very very clear it is a device if it does not achieve its primary intended purposes through chemical action in or on the body or through metabolic action if it does achieve its primary intended purposes through metabolic action or through chemical action it is a drug that's what's left there's a universe of medical products some are devices and those that are not devices are drugs that's the other thing that's the way the statue read before nine hundred and ninety but congress got rid of the exclusion from the drug definition of everything that's a device and i understand that the immediate task there was to open the way for combination products but that clearly could have been done in a way that excluded devices that are not combination point it is quite clear in the legislative of history st of all the congress viewed this as being a slight alteration in the definition of drug that is in the in the senate report i can give you the cite if you'd like the senate report on the drug is just before the part the st time the congress says this is a slight alteration of the drug device which is intended to permit combination products in metabolic activity it just seems puzzling why congress would ever move that definition i mean you've reminded me that because the choice as between the device track and the drug track is determined by primary mode and of all i know that exclusion even needed if there's a rd category that congress creates and says if it's a combination we don't automatically include it in device just because it meets that definition nor do we automatically drug because it meets that definition instead we call an f d a to determine its primary mode known no need to take away the limitations on drugs to those that that operate through chemical or metabolic functions you're on the the the language that was removed from the this case it was unclear exactly where the line was drawn between drugs and devices quite explicitly the safe the original medical bisect in one thousand nine hundred and six quite explicitly said we need to as congress we need to set up a clear line between drugs and devices they left in that earlier language but it really almost became surplusage because they said here's  the fence if you're chemical action but metabolic action you're a you're a drug if you don't achieve your primary intended purposes through those that mode of action you are a device so they the lang serve just to try to describe without being exhaustive some of the more common devices your honor originally when that language was in the statute that was the only definition of what a devices and i did want to address very specifically your point judge henderson about how could this product be a device and i would turn to st of all the in its current language the language it's in the briefs talk about how it appears to meet the definition of a device in the district court the f d a actually admitted that it does fall within the agents because judge henderson one of the parties in that matter put in into their citizen petition how could a contra fast agent possibly be be a device and f d a correctly in our but it is quite broad if you read it yes it talks about device contrive and so on and so forth but it also talks about similar or related articles article is actually the same way that drugs are described there  so it's really what the distinction is once you have a medical product in other words once there the and the use is intended to treat diagnose cure disease it is a medical product and then the distinction is either does it achieve its principle intensive purse was purpose a primary intended purpose as through chemical action it's a drug if not it's a device and if i could actually i think i don't think he did  purpose but he he said f d a could switch what's a device and what's not through regulation that's not true if you look at twenty one u s c three hundred and sixty c it specifically says medical devices will be class twelve or three and these are how these we make the decision you make the decision of the day as to whether it's class twelve or three well mr mitnik might not say well that that doesn't say all medical devices but if you look back at the legislative history of the medical device act in one thousand nine hundred and seventy six that resulted in this classification system for medical devices the legislative history is judge both bur said says all medical devices fit into one of these three classes so if you can't excuse a medical device from the class by regulation the statute says if it's a medical device which it makes perfect sense is because it's a medical device because it meets the definition of a medical device has to be classed in this particular manner so i met my understanding of f d a as response to that is once they choose to treat it as a statute permits them to as a drug then it no longer has to fit into twelve dollars or three a drug and only address that that's correct i wanted to make sure though that it was clear that it's a statute that requires that what f d a claims is we have the discretion to regulate to classify and regulate a medical product as a drug because it meets the intended use portion of the  of both of the the definitions of the drug and device definition but i want to turn now to the reasons that they don't have that discretion st of all they can point to nothing in the statute that says where congress said we a to have that discretion the only thing that they point to is the removal of the clause but does not include devices or other components accessories parts etc so it made a big it on the on his face it seems like a pretty big deal but they did not touch the structure of the definition of what a device is or how a device is required to be regulated and classified also the  and so if it's same big us about what they intended by that you're permitted to look at the legislative history and the legislative history discusses this particular change in two different places the in the in the legislative history both times it says it is intended to permit combination products to be regulated as drugs under appropriate circumstances combination products that's focused on combination products and our product is not a combination product rules about how you have to define medical devices and how you have to classify now mr winnick talked about the rad lax case and he again mis represented the holding  in rab lax and the the language in red lights in the final brief that f d a filed it said the narrow versus general or specific versus general canon is restricted to these particular circumstance that's actually not what brad lacks said but what rad judge scalia said in that decision is it is perhaps most frequently applied in those kinds of situations but if you look at the other eighty this is what the supreme court said about it it is an old and familiar rule that where there is in the stain statute or particular enactment in a general one which in the most comprehensive sense would include who wasn't raised in the form or the particular in act that must be operative this language is still valid it was recently cited i think it was in the eagle case if i remember right in the enron decades it is still operated  each one same an argument that right next to each other where there is a specific that definition or a specific provision and then there's a general provision when the conduct that issue falls within the scope of both provisions the specific presumptively governs whether or not the specific provision also applies to some conduct that falls outside the gym so it's clear that the the the  narrow or specific versus general canon is not restricted to the circumstances that mr winnick has has argued i would like to go back to in terms of the the device  definition and why it is such a clear it's such a clear line that's drawn by the by the statute the line that still remains and the the reason is because as i say it's a universe of products they're medical products medical devices are specifically defined what is not a medical device by default is a drug makes perfect sense it's implicit but as was held in the eagle decision implicit if i can say just hope that that case if the text clearly requires a particular outcome than the mere fact that it does so implicitly rather than express thank you judge henderson the one of the things that you may need to get to if you don't believe that this case is resolved on chevron step one is whether the the decision that the other case is the bracco decision that came out of the district that response to the citizen petitions as well as the government's view of the case now distorts the holding in that case actually was of course it would be controlling on this court anyway but what the holding in that case was they were they were to hold things really the st is you have to treat similar products in similar fashion that is a that is a holding i've actually argued on it's a correct that regulate these products either as a drug or device and that is not a decision it's likely what he actually decided was and instructed f d a to do was either treat these products the same or explain give me a rational give me the reason why you're not treating us so it's not the holding that there was that there was this discretion i don't think any court has ever recognized that there is discretion  text the purpose in the history of the statute i be happy to answer any other questions i have a question and one and how is a device formulary which is part of the u s p were the bible in terms of what was a drug and what was it devalues and whether and that it had to meet these particular requirements and specifications in order to qualify for a listing in the u for radiological health would be in fact superceded by the statutory definition anyway but i'm confident that if it had been listed in u s p as one or the other one of the parties has before you would have recognized them and brought it to your attention so is recognized or two intended for use or intended to affect so how do you read the or comes after h two that's correct but it's if you look at the way that the statute is indented and so forth ok thank you any more questions all right mr winnick why don't you take two minutes to go hit i just i think you answered this miss far but i just wanted to  confirm it i heard mr winnick to say that he's not attracted to the suggestion that the prefatory language that you describe as somewhat of a is actually playing any role in distinguishing devices from drugs and i thought i heard you to say more or less the same thing that you wouldn't you wouldn't see that as operative in addition to in your view or in contradistinction to and mr winnick spew the metabolic and or chemical action exclusion you both think  the lead in language doesn't really plane operator all anymore i'm glad you asked that question your honor and if i might give just a couple of examples i think it would help help the court understand  we both agree that that language in terms of you know articles in the drug definition and instrument apparatus implement machine contrivance implant bubble blah is very very broad language it is the intended use of the product that makes it a medical product and it is the chemical action that we contend in this case makes a device now it's seems sort of counter intuitive that something that you swallow would not be a drug and that's precisely why this explanation why this definition is in here on chemical action setting up the phone so for example we mention in our brief there is a device that you swallow that is an alternative to a colon osca pee that passes through your system and takes pictures of your g i tract as it's working its way through the fact that our product is swallowed the fact that it's liquid does not make it necessarily a drug it is a device because it is not achieving its primary intended purposes through chemical action within or on the body of man or being metabolized it is inert it does not chemically interact with anything it's passes through your system mixes created if i might take just a quick nd i actually my daughter is a pediatrician and i was talking to her about this argument the other day and she said we just use today we had a child they wanted to check motility in the child's digestive tract so they gave the child scrambled eggs with barium sulfate in it and then they watched through the x rays it passes through the system so that's not a drug like effect that is a device like effect showing through as it goes through the tissue showing whether there's deformities in the in the tissue and showing how it tracks through the system appreciate your allowing me to divert into that little and i don't see why it isn't a drug like a sect if both are used for diagnosis variant sulphate what you've just described was a diagnostic that's correct and devices speeches which is what a for use in the diagnosis of disease or other conditions if this is an age to under device devices can be used and frequently are used mostly or used probably in terms of helping to diagnose diseases but in their fact the sam corollary of that clause is that the things that do which chemical action there probably are intended purposes to chemical action and that are medical products they are drugs that's what's left future to apply if you're more broadly than it has done in thirty years that the court won't be able to confront that manufacturers can easily bring the challenges to any future decisions that go beyond the narrow term i said i would remember you said there is no concern here about superfluid a but i think the questioning that you heard from the bench in your argument and chafe was why is your reading not rendering the device definition in so far as everything that's at their bias is also a drug and our answer is that the f d a might do that if it were just deciding to treat every devices but it's not doing that or even close and it's not asserting the authority exercises its power and i thought that it was the former that the superfluity should be identifiable from just reading the statute without knowing something falls in the exclusionary clauses it must be bigger those a drug and not it and that's what's your best answer to mr for his point that this was something that congress thought of as a small change and indeed if it had intended to throw a lot of discretion into f d a as court wouldn't you expect that there would be some discussion of what guides that discretion so i think a few points one it has been relatively small change again it hasn't come to the court in thirty years as yet very rarely nd the congress did put in the  suggest even if you think you know congress might not have meant to do this you know the only the only effect that would have is that you put less weight on that decision recently when it doesn't go to any of our more fundamental points out reading into the definition a limitation simply isn't in the text and that is not necessarily implied by the structure of the statute you mention that the i mean i find i do find it notable that it's been thirty years and this is the st time this issue has come before us it makes it seem like it isn't a dramatic change but then when you say the f d a asserts this authority very rarely i almost find that to be an in comprehensible sentence in view of the way you read the authority because every time it regulates a device as a device it exercises this authority in your view we'll except that is there no there is no statutory meaningful distinction other than the biochemical or the chemical in metabolic carbon so the way i see it your honor is this it to mr you would think that every time in manufacture goes to create a new product beyond the crutch or whatever else they are you know sitting there in a state of a certainty about what is going to do but the reality is that for the overwhelming majority of products regulation point where you know its historical matter there's been some impunity in how the product is treated and we identify sunscreens contrast agents is one but this is not some large list of things and you know even as products in this category  they so i had thought that part of that there was a distinction between what's included in the device definition which distinguishes it from the drug definition in terms of machines and implements versus what x could from the device definition which isn't necessarily included in the drug definition but i think i have been operating under what may be and correct view of a multi polar f d a regulatory regime that something could be a drug or a biological but now that i've been corrected that i buy all biologicals or drugs and where you're talking about a cosmetic statutes explicit about how to deal with the overlap and in fact so so if it's if something that's excluded from the device definition does that does that make it here but doesn't that just reinforce the district court's reasoning i mean you're saying no because everything that's in the device definition is in the definition and therefore the fact that it is every device as a drug in the statute there has to the f d a has to have good reason for creating as a drug or products at a sites that satisfy the device definition and it has to be consistent with the