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Tips on completing the This Report And The Summary Report Table Are To Be Completed By The Applicant When Submitting A 510k That References A National

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Advice of Fulfilling the This Report And The Summary Report Table Are To Be Completed By The Applicant When Submitting A 510k That References A National

welcome to the medical device made easy.podcast here is money velocity from easy.medical device calm and today we will go.to the USA I yeah a few months ago we.have done the same with another episode.what the USA to see this initial lot.Thunder of the lien Eric Wacom so it's a.consulting firm in the US and Michelle.will help us to understand how to reach.draw products in the US and to answer.some of the question that maybe you are.asking yourself if you are in Europe and.if you want to go to the US market so.Michelle welcome to the medical device.Medici podcast thank you for having me.I'm excited to be here I'm also excited.that I have said we were connected on.LinkedIn so I see a lot of your.activities they're also related to MGR.so you are not specialize only on FDA.but also the you market so you're not.helping your customers on that so yeah I.saw all your activities and you are.really doing a great job I saw some.posts that you are doing some cool down.of when the MTR will be arriving so.exactly Indy is coming so he ought to.look at that okay so Michelle just for.the audience can use just start you.introduce yourself and also introduce.your business and then we can go to the.questions about how to ensure the.products to the US sure my name is.Michele only nor a QA I started the.business and named it lean because I'm.particularly passionate about helping.startups and small businesses find.sustainable quality and regulatory.solutions a lot of consultants to treat.regulatory quality like it's a one-stop.shop and they have this quality system.and they give the same thing to every.customer over and over and I just across.my career just saw that being so big and.bulky that the clients didn't have the.resources to manage it and it created.compliance issues so my niche client is.small startups midsize companies that.need customized.sustainable solutions so great so then.you can really help us to understand how.to register our products in the u.s..mainly we will focus on manufacturers.that are in Europe and that want to.export the products to us so my first.question to you is mainly how they.should start to register their points to.us what exactly should consider first.yeah so you know everybody knows that.the classification in the u.s. is risk.based class 1 2 & 3 class 1 devices you.know typically are a little bit lower.barrier to entry and then class 2.devices or kind of men risk profiles and.in class 3 typically life sustaining.life supporting and plan tables but one.of the big differences in the the.pathway between the US and the EU is.that the US has what they it's a.three-letter product code that they call.it and that product code defines the.definition of the device the regulation.associated with that product code has an.intended use associated with it some and.so so that that three-letter product.code is probably the single most.important piece of information that a.company needs to know about so mainly.where then those manufacturers can find.those product codes so do we have a.predicted for every product or maybe.there is some products that still don't.have one yep that's a great question.that's a trick question to you start.with the product code database on the.FDA website and you you come up with the.gin most generic way that you could.define your device like the face mask or.just mascar and then you put in and you.see all the options that come up and you.start going through them and eliminating.okay that one's oxygen mask not a face.mask.and then you get come up with a handful.of product codes that could fit your.product it has to look your intended use.and then from the ones that sound like.they can fit your product what does the.regulations intended you support and so.to your point the ones that don't have a.product code yet are likely you're gonna.be going through what is called a de.novo which is a quest for class it.basically ends up in a classification.with a new three-letter product code.okay so yeah you've just introduced a.new world which is de novo yeah I think.what we know mainly from from the FDA.when we want to register our products is.some 510 K I think is the most used way.to register our products I know that is.in de novo which is starting to become.famous there is also some another one I.think is PMA so there are a lot of.pathway if I can set register prediction.in the u.s. how how our customers or how.the manufacturer should choose between.those ones yeah well even that often.comes back to that three letter product.code so it's really important to get.that right from the start because if a.product code already exists it tells you.what class your product is one two or.three and then it also tells you what.submission path is associated with that.product code if it's a 510 K if it's a.PMA where it gets a little tricky for if.a de novo is appropriate is say you find.a product code that may be close but not.quite and all the products that have.been cleared under that have got well.they may be similar in some areas maybe.your product has new technology new.intended use or new indication for use.that goes beyond what the.product code or those other products.have and in those cases that's where you.would wit need to pursue the de novo so.it looks like if we are trying to go to.the US you have as you mentioned first.to go to a certain database to see all.the product codes and everything so but.you have to compare yourself to already.existing products I suppose I know that.the 510 K is mainly looking for.predicates or an equivalent product so.I'm I was working then on those.different things so are you first.looking for new covalent products on the.market or and if you don't find where.are you going there yeah so the FDA is.is largely based on a concept called.substantial equivalence now this is.different from where like the clinical.evaluations in Europe or moving where.it's you know there's no substantial is.identical or it's not exactly so.substantial equivalence means a certain.amount of differences are allowed as.long as they don't raise new questions.of safety and efficacy so if there is a.case you can make within a 510 K that.yes these things are different but.they're not don't raise additional risks.then use 510 K still may be viable for.you but if if it raises if there's.enough differences that it raises new.questions of safety and efficacy or.intended use indication for use the FDA.is going to want to see more more of a.de novo pass and what about the BMA what.is this thing what is this thing that's.that's the Beast of all submissions.exactly yeah.and so you know five CK's can be between.you know a thousand fifteen hundred.pages and that's a lightweight compared.to the PMA the PMA can be third like I.saw one that was 33 green binders that.were about you know three interested a.piece so it was back in the day when.they had that before.da accepted eCopy so you know just to.ship it to the FDA with like thousand.dollar gene.so mainly PMA's mainly like the product.is life-threatening so we have to make.as many tests as possible a lot of.clinical investigation to really prove.to the FDA that our product is correct.so this is the extreme let's go to the.other extreme so in Europe we have the.class one products which are not risky.at all and even they are self certified.so it means that we do need a notified.body we just go through the path of.creating the dose here and then we.register the price in the country but.without going through not by body is.there the same situation in the US or.not so in in the US every device.regardless of its classification if its.class one obviously it's 510 K exempt.most Omar but then there's also a subset.that are also GMP exempt which means.they're exempt from the bulk of the.quality system regulations so that's.something that doesn't exist in Europe.yet no need of the it means that it's.there is no need of a quasi management.system is it correct correct except for.complaints and records okay.you still have to have those two.elements but you don't have to have.supplier controls production controls if.it's GMP exempt okay even with that.that's not something that exists in.Europe yeah and even for devices that.you sell certified you're expected to.have design controls which in the US.class one devices are the bulk of them.are exempt from design controls except.for a handful so I suppose many's.because the risk is really really low so.there is no and we know maybe the.products very well so there is no need.to really take care of this or there is.no really issue on the market about that.right yeah they're they're almost.borderline enforcement discretion.okay so mainly so it's a good.because we also talk to you about the.GMP or or you're quite management system.and us so mainly we have the product now.we know the classification we know then.the path we have to go to register the.products to to the US what about the.quite imagine system in Europe we are.many using ISO 13485 what are you using.in the US so in the US 21 CFR 820 is.still the law it's still regulation and.I know that the FDA has been talking.about adopting ISO 1345 well that's.tricky the law the 21 CFR is love.exactly so is a voluntary standard and.so and it changes every three years like.me it's a literal act of Congress a.change in the regulation passed so many.we have I think the the Canada or so.started to do the same by removing the.some of their regulation to put them in.a kind of a common pot with that with.the MD sub so us now it thinks about.that but what will be the advantage for.us to maybe move to ISO is there.something that will be helping them or.it's better or it's because it takes too.much time to maintain a quite management.system low you know I really think that.the difference in the u.s. is gonna be.in the inspection technique okay because.right now the us the inspectors use.what's called Kusa the coil system.inspection technique all of the auditors.have been or not inspectors have been.trained to this particular methodology.and it's very different in the thought.process to the ISO based audits which.are a little bit more checklist and.element by element driven so while ISO.audit technic that they do look for that.system interaction they have to make.sure they cover.every item on their checklist and the.FDA is not checklist driven they are.system driven and if they find a problem.in one system they they follow it all.the way through your quality management.system no it's it's really true so I had.the chance to or the non chance to be.audited by notified bodies and by FDA.and the technique is really different I.think one is as soon as I you are guilty.until I find that you are not when the.other is more that yeah until I don't.find anything you are you are fine so.there is no G so it's it's really.different mataichi but yeah really.people that have to reserve an FG.auditor have also to understand that.it's not really the same way that they.are expecting from from not we there was.a lot of information that you can not.show to them like management review.information or like I mean there was a.lot of thing that we should not show to.them but show that the process of the.system as you imagine is working but no.need to show all the details of what is.inside that's something that a lot of.people don't realize about the medicine.is that the FDA does not accept the.medicine certificate they take the.report they read it and on it the report.for themselves and make sure they agree.well you know what's in the report.internal audits management review.supplier honest all the stuff that the.FDA inspectors can't look at exactly so.it's exactly that week we had to hide or.not - sure - lamian come on you know so.just one thing also because I had also.this experience with FDA as an auditor.so in the US they can come to audit you.without any further notice or maybe one.or two days of notice but in Europe they.have to inform you I think three months.in advance.well they Europe has started as.especially as a result of MDR but even.in advance of in VR.required unannounced at least supplier.honest okay and so I've had several.clients that have had notified bodies.show up on their door and like in every.notified body that I've signed a.contract with over the last year is that.the one of the first questions they ask.is give us your holiday schedule okay so.we know when not to come and if we come.and you're closed we're still billing.you and we're coming back yeah true.let's see it's exactly I think I had I.had an episode with studied with flu so.I will just put the link for that and.yeah it was clearly that you have to.mention your holidays you have to tell.when you are here or not that the.auditors are not surprise coming and.knocking at the door nobody's there.because yeah it's important also for.them but yeah it's great so Thank You.Michelle for all those information I.think it's really interesting for all.those manufacturers that are trying to.conquer the US market and I hope they.will have they will make it but mainly.what can you do or what are you doing.actually to help those manufacturers to.enter the US market well you know it's a.lot of Education for my customers and.some of them are learning by trial and.error.letting the getting in trouble with the.FDA and then saying oh hey Michelle when.you said that we should do so and so now.would be the time to do that because the.FDA just odd so trying to to cut that.learning curve for the clients I have a.lot of videos about this process on my.website that any of your fans can't can.look up to try to get better informed.and then I also invented it just at the.start of our talk is that I customized.the solutions but I can also customize a.staffing plan for you so if you're not.in a position to have a regulatory.quality person on staff we can build a.system for you and then run it for you.as well so that's another way that I can.I can be helpful is.keeping that overhead low and keeping.you compliant at the same time no it's.great and mainly you are as I said.supporting customers in the US and also.customers out of us so is it only Europe.or you have also some kind of customers.in Asia Pacific or some other countries.I have customers all over the world so.diverse I take I take customers from.everywhere ok great so I saw some dogs.running out so I know that on the on the.on LinkedIn you are also featuring them.because they are kind of your associates.there so whatever they are mission there.right right on cue.this this one came up and asked to be.held and her name is Lucy and unless I.paint it pink she is a natural blonde.Mohawk ok lash of Chinese Crested inter.great so there's Lucy okay she's the.chief therapy officer or the CTO okay.for snuggles and the bully dogs so.they're there I call the boy dogs the.chief fun officers okay and so and.they're also I made a joke that I'm.gonna I'm gonna sell the business and go.champion pug dive coach okay is the.swimmer and he loves doing belly flops.in the pool no it's great as I said I'm.really enjoying seeing all your content.are you kidding so I really encourage.all the people to to go to follow you.can you mention again you ash tag that.you are using you're always hashtag MBR.is coming mg is coming sometimes we put.it up with a picture of the puppies like.oh it's okay it's gonna be stressful but.we have puppies lower your blood.pressure and get you through this yeah.I'm also I'm also putting now kind of a.post on you can USA accept you know what.I say Keep Calm and accept India so.because a lot of people are starting to.think about this.don't think too much just accept it and.move forward.acts like they always go together yeah.exactly.no it's great so Michele something else.for the audience let me know how I can.help.yeah so I think for that please let me.know where they can find you so I.suppose nicotine as we said I would put.also the link I think of your website so.lean QA alright calm.Eric you a.com so calm and yeah so then.people can contact you directly and I.hope they can they can ask you the.question difficult questions so that you.can answer them systemize has you mercy.or services to them so great exactly.this what's always what I'm asking if.you have some question please let us.know so that I can also bring back.Michele so that you can try to answer to.us and maybe if you are going to the US.and you have a difficult question or.difficult situation let me know and I.will I will invite again Michele for.another pizza okay so Michelle really.thank you for your help and thank you.for all the information you provided I.think it was really valuable for for the.audience and and I wish you a nice day.yeah thank you.[Music].

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What is FDA Form 356h?

An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. It notifies the company’s management of objectionable conditions. At the conclusion of an inspection, the FDA Form 483 is presented and discussed with the company’s senior management. Companies are encouraged to respond to the FDA Form 483 in writing with their corrective action plan and then implement that corrective action plan expeditiously. Here is some m Continue Reading

What is a Form 1572 per the FDA?

This question has been plagiarized from another website. Test: Biotechnology Test 2 Unfortunately, the person who copied it here did not even understand enough about it to know that it has to do with Primary Investigators in research and not “Private Investigators” or “Detectives”.

Who signs FDA form 1572?

This question has been plagiarized from another website. Test: Biotechnology Test 2 Unfortunately, the person who copied it here did not even understand enough about it to know that it has to do with Primary Investigators in research and not “Private Investigators” or “Detectives”.

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