Medical Device Regulations / FDA Approval

Рет қаралды 31,965

Күн бұрын

The FDA is the federal agency that regulates Medical Devices in the United States. It's important to know all the pathways a company can take for getting their medical devices approved, and that's our goal!
In this series of videos we'll be showcasing anything and everything there is to know about medical devices, FDA regulations, and maybe even some startup advice. Our goal is to be able to feature prominent industry experts as well!
Our resources for this video came directly from the FDA:
www.fda.gov/home
Let us know if you learned something new from this video or have any other questions or topics we can answer on the next one, thanks for watching!
/ thebmelife

Пікірлер: 128

@ghandigreat3836 4 жыл бұрын

I see you’re stepping up the quality, keep it up!

@TheBMELife 4 жыл бұрын

Thank you there 👀 Mr. Ghandi

@TGIA0310 3 жыл бұрын

Absolutely fantastic work! Thank you very much! -fellow BME from Singapore

@TheBMELife 3 жыл бұрын

Thank you so much for the support 😊 Greetings to Singapore!

@kirthigadeviss7795 2 жыл бұрын

Never seen such a clear explanation!

@TheBMELife 2 жыл бұрын

Happy it helped! 😊

@mayurbhavsar461 2 жыл бұрын

This is exactly what I wanted to know. Thank you very much kind lady..! :)

@TheBMELife 2 жыл бұрын

Thank you, kind Mayur!

@ulhiker Жыл бұрын

Well done! That was so easy to understand!

@TheBMELife Жыл бұрын

Thank you so much! Glad it was helpful!

@dishantshah5965 2 жыл бұрын

Great video, you solved a lot of my doubts!

@TheBMELife 2 жыл бұрын

Happy to help! Let me know if you have any concerns or questions I could help with.

@dileepchandran392 2 жыл бұрын

thank you. very informative. simple and clear.

@TheBMELife 2 жыл бұрын

Hi Dileep! Glad you found this helpful. Let me know if I can assist you in any way.

@ms2pranav 2 жыл бұрын

Thank you for the information and the clarity 💐💐💐👌👌👌

@TheBMELife 2 жыл бұрын

Happy to help!!

@user-kl3nd1kh8e 2 жыл бұрын

Very understandable! Thanks you very much

@TheBMELife 2 жыл бұрын

Happy to help!

@Biomeducated 4 жыл бұрын

This was highly interesting for a biomedical researcher's point of view! And about that video quality though... ;)!

@TheBMELife 4 жыл бұрын

Biomed Master thanks Kevin! And you know we’re always stepping it up with our video capabilities. Or maybe Adrian just likes being really extra 😂

@mohammedtjr9236 2 жыл бұрын

Wonderful job!!

@TheBMELife 2 жыл бұрын

Thank you!

@HamzaHajeir 3 жыл бұрын

Nice and well organized content !

@TheBMELife 3 жыл бұрын

Hamza Hajeir Thank you! Really appreciate it 😊

@viky007veera Ай бұрын

Simple and effective 👌🏻

@arulmani8132 5 ай бұрын

Thank you for good session.

@TheBMELife 8 күн бұрын

Our pleasure!

@thilakchakaravarthi9428 3 жыл бұрын

Love you!

@Joerogan.olympia 2 жыл бұрын

Very helpfull video!

@TheBMELife 2 жыл бұрын

I’m glad you found it helpful, Nick! 😊 Thank you for the feedback.

@HemangDarji 2 жыл бұрын

Thank you very much very helpful.. 👍☺️

@TheBMELife 2 жыл бұрын

Glad to hear! ☺️

@MrSimonSells 2 жыл бұрын

wow how old are you and you know all this information!? This was very helpful, exactly what I was looking for. Thank you!

@TheBMELife 2 жыл бұрын

Haha I am currently 24, maybe a bit younger at the time of recording. Just did some research at the time, but I currently work as regulatory consultant! Happy to help!!

@alejandrocelery3091 3 ай бұрын

The t-shirt is way too cute!

@jamjam3448 3 жыл бұрын

Very nice video

@TheBMELife 3 жыл бұрын

JAM JAM thank you!

@mohammedtjr9236 2 жыл бұрын

Hi there! Great content! Thank you! Wondering how are general wellness devices cleared? Thank you

@TheBMELife 2 жыл бұрын

Please refer to FDA's guidance document for General Wellness devices: www.fda.gov/media/90652/download

@alexamartinez570 4 жыл бұрын

Nice quality 10/10

@SanAntonioWedding 4 жыл бұрын

I agree! Stepping up the graphics!

@TheBMELife 4 жыл бұрын

Thank you!

@Biomeducated 4 жыл бұрын

@@SanAntonioWedding Indeed! ;)

@mukeshp1427 3 жыл бұрын

Outstanding, useful video, I except you can do more videos in this Regulatory domain

@TheBMELife 3 жыл бұрын

Thank you! More to come! :)

@MavenProfconServicesLLP 3 жыл бұрын

Hey Mukesh, to know more about regulatory affairs and its updates please check out our channel. And don't forget to subscribe to get more updates! Are you interested in selling your medical devices in various countries, but are not sure how to go about meeting the Medical Device Regulatory requirements or quality standards? We help you get certification from various countries including India, Europe, the US and 20+ countries. We have a one-stop solution to help you throughout the process and also provide you with yearly updates as per the changes in regulations. Check out our channel and videos to know more about the same. kzfaq.info/get/bejne/oNmAoc-dt66vm4E.html

@z-kh2948 2 жыл бұрын

Nice !

@TheBMELife 2 жыл бұрын

Thank you! Please let me know if you have any questions.

@MB-qz7xb 2 жыл бұрын

Thanks you very much please i am following you i hav idea and i learned from you

@TheBMELife 2 жыл бұрын

Glad we could help! 😊

@MB-qz7xb 2 жыл бұрын

@@TheBMELife I am looking to hire someone to submit 501k application ? Do u provide this service or know someone who do ?

@TheBMELife 2 жыл бұрын

@@MB-qz7xb Yes! I work at a regulatory and quality consulting firm. Feel free to email me to meri@thebmelife.com to connect!

@akay435 2 жыл бұрын

Hi thanks for the information. I've worked in smaller companies they simply 3d scan the device ( orthopaedic implant specifically) and make identical implant by directly 3d printing and/or vmc machining. Is this legally allowed. In fact in audits also we used to specifically show that all our dimensions are the same as that of a predicate device, apparently to demonstrate that our medical implants pose no new safety risks and are at least as safe as the predicate device already in the market. I wonder why auditors or US FDA doesn't care about copyright infringment?

@TheBMELife 2 жыл бұрын

Well, the FDA simply cares for about devices being safe to people. They could care less if you’re copying another company. Company’s need to protect their devices with patents. I think that’s the best way! I don’t know much about this, but yes, in short - FDA only cares about safety

@ToyTime786 2 жыл бұрын

Hi .. what could be the pathway for a acupressure mat.. I guess that is class 1

@Laserextech 2 жыл бұрын

Great video! If a medical device is a Class 2, 510k exempt Physical Medicine Device, Part 890, is it simply a matter of registering the company on the FDA database and proving GMP, product labeling in order to allow the product to be marketed in the US. No 510k, substantial equivalence is required?

@TheBMELife 2 жыл бұрын

Hello! I am glad you enjoyed this video. Generally, Class 2 510(k) Exempt devices only need to register their establishment and list the device on FDA's site. You'd still need a QMS that is compliant with 21 CFR 820, 803 and 806. Once you register, you should expect an FDA inspection within 2 years of registration. However, I did some research and there are some exemptions within the Part 890 devices. 21 CFR 890.9 describes the limitations and cases where you would still need a 510(k): www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=890.9 If you have further questions, feel free to reach out to me through email: meri@thebmelife.com Thank you! Meri

@MedievalArts007 Жыл бұрын

How to LST number for sanitary pads

@vyshnavigs1434 2 жыл бұрын

Hi! Great video How can substantial equivalence proved for a novel device of class ll if it has a low risk

@TheBMELife 2 жыл бұрын

Depends on the device.. Feel free to email me with more details meri@thebmelife.com

@dunotrustistrue5565 2 жыл бұрын

nice

@TheBMELife 2 жыл бұрын

Hope it was helpful!

@williamhui6195 2 жыл бұрын

We found our N95 respirator can be registered as FDA product code MSH in FDA database with no 510(k) is needed. Once we got the establishment number issued by FDA, we can only use FDA registered for our N95 respirator. However, why we cannot declare our N95 respirators as FDA cleared? How should we do if we want to be FDA cleared eventually?

@TheBMELife 2 жыл бұрын

the term "FDA cleared" is typically only used for 510(k) cleared devices. If you'd like to email me to meri@thebmelife.com and share a little more information, I'd love to help out!

@MariaFatima-mv7kx 2 жыл бұрын

Link please for medical devices list according to FDA regulatory class devision

@ailecdreifuss8627 3 жыл бұрын

Who is the person responsible for submitting the CTA to FDA the clinical trial manager?

@shaziafirasat9926 7 күн бұрын

how to check if which Lasers are approved in Canada

@Synergywellnessny Жыл бұрын

I’m trying to bring a medical device to market and could use your help.

@TheBMELife Жыл бұрын

Hello! Thanks for reaching out. Please feel free to contact me with more details to meri@thebmelife.com

@MrEnigmapaul 2 жыл бұрын

The 510(k) seems like it could lead to a lot of loophole opportunities. How does the FDA really determine that a device is substantially equivalent without introducing new safety risks?

@TheBMELife 2 жыл бұрын

That is a great question. If you look at FDA's guidance document for evaluating substantial equivalence (SE) there is a flowchart that describes the decision making process. Both devices (your device and the predicate) must have the same intended use. Then you evaluate the technological characteristics. Most of the time, there will be differences. These differences you must support with test data, the use of a reference device, etc. The differences also shouldn't raise "new questions of safety and effectiveness". The FDA definitely takes their time in reviewing these applications, and the review is very meticulous. You'll also need to present a risk analysis/assessment in most cases, and describe how you've addressed risks associated with your device. Every review is unique! Hope it helps.

@MrEnigmapaul 2 жыл бұрын

@@TheBMELife Thanks! Is it possible for the public to review the risk assessment or would you need a copy of the 510k to really understand that?

@sidhantmishra9875 17 сағат бұрын

Could please provide link for list of devices which are exempted from 510k submission

@bluethundr 9 ай бұрын

Is there a way to tell if a company has submitted a device for FDA approval? Or can you only see devices that have been cleared? We are trying to determine if Dr. Shore's tinnitus Auricle device has been submitted. And wether she has taken a DeNovo or regular 510(k) regulatory pathway.

@TheBMELife 8 ай бұрын

Hey, that's a good question! It would be awesome to see what companies are undergoing a submission. But no, we are only able to see devices that have been 510(k) cleared or granted De Novo. FDA has separate databases for each. You can search by company name to see if they've received either. Hope this helps!

@vidyamenon9240 2 жыл бұрын

Can a class III medical device claim for substantial equivalence to a predicate device under 510(k)?

@TheBMELife 2 жыл бұрын

Hi Vidya, thanks for your question! There used to be Class 3 devices with 510k clearance. but the FDA gradually transitioned them all to PMA.

@Iamconradbrown 10 ай бұрын

Is there an existing menstrual cup brand with the name "Puddle Cups" or any similar variation that is already registered with the FDA?

@TheBMELife 8 ай бұрын

Nope. You can search device's by name and company here: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/textsearch.cfm But please keep in mind that FDA doesn't regulate trade marks or anything of that sort. That is outside of their purview.

@safamohammed5539 Жыл бұрын

Name of the music, please!

@Santiago-if3yt 4 жыл бұрын

I am a BME major, but eventually want to start a medical device company. Do you have any experience with applying for any of these?

@TheBMELife 4 жыл бұрын

Santiago I haven’t worked on a medical device myself (hopefully one day!) but at the startup I work in we are currently in the application process which involves a lot of testing 😅 that’s so cool you want to make a medical device one day! 💪🏼👏🏼

@alexamartinez570 4 жыл бұрын

😯 😎

@dijeh10 3 жыл бұрын

Is it possible to train yourself on medical device based on the information from the FDA site and other sites. If so which sources would you suggest? 21 CFR?

@TheBMELife 3 жыл бұрын

Yes! I am always peeking on FDA’s website, and find amazing information. 21 CFR 820 is good for learning about the overall requirements for good manufacturing practices and keeping a good quality system in place. But there are many other kind of resources! But in short, yes. FDA has a lot of great information!

@dijeh10 3 жыл бұрын

Okay, thanks for the reply. Great channel.

@MavenProfconServicesLLP 3 жыл бұрын

Are you interested in selling your medical devices in various countries, but are not sure how to go about meeting the Medical Device Regulatory requirements or quality standards? We help you get certification from various countries including India, Europe, the US and 20+ countries. We have a one-stop solution to help you throughout the process and also provide you with yearly updates as per the changes in regulations. Check out our channel and videos to know more about the same. kzfaq.info/get/bejne/oNmAoc-dt66vm4E.html

@ShimiVa 2 жыл бұрын

where is the link to the list you talk about at 1:35?

@TheBMELife 2 жыл бұрын

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm

@jennyjenny1951 2 жыл бұрын

May I ask you how to check the medical application online? We applied it last December to FDA . Thank you

@TheBMELife 2 жыл бұрын

What application are you referring to? Feel free to email me to discuss more details meri@thebmelife.com

@beast8623 3 жыл бұрын

Is there a reason you didn't go over De Novo?

@TheBMELife 2 жыл бұрын

Not a good one! Other than, at the moment I was still a student and did not necessarily comprehend what a De Novo meant. Now that I am in Regulatory Affairs, I have a much better understanding of the different pathways. I certainly need to make an updated video on this. Thanks for your question!

@bluethundr 9 ай бұрын

What about DeNovo devices?

@TheBMELife 8 ай бұрын

Will have to make a video about that! Here is FDA's guidance on De Novo's, in case you haven't read it already: www.fda.gov/regulatory-information/search-fda-guidance-documents/de-novo-classification-process-evaluation-automatic-class-iii-designation

@slz1119 25 күн бұрын

Hi, madam, if I want to market a class I medical device, do I need to submit any dossier to the FDA?

@TheBMELife 9 күн бұрын

It depends! Some Class I devices do require 510(k) submissions.

@martinpark7437 Жыл бұрын

Hi, question... For personal lube, I was advised for 510k. what category would that be?

@TheBMELife Жыл бұрын

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=NUC

@TheBMELife Жыл бұрын

let me know if you have more questions!

@martinpark2808 Жыл бұрын

@@TheBMELife Thank you so much!

@cyborglawpolice 2 жыл бұрын

#HealthyMeals #FDACertifications #Food #Nutrition #Ingredients #IntelligenceAwareness #America

@TheBMELife 2 жыл бұрын

😃

@slz1119 8 ай бұрын

Are all 510(k) medical devices predicate devices?

@TheBMELife 8 ай бұрын

Hey, that's a good question! Let me put it this way: A predicate device is used when you want to make a 510(k) submission. A predicate device is, in simpler terms, a device that is "similar" to your device. But a valid predicate device must meet three things: 1) it must be a legally marketed device (this can be a 510k-cleared or De Novo device). 2) it must have the same intended use as your device. 3)it must have similar technological characteristics, and any differences in technology should not raise new concerns of safety/effectiveness. So, to answer your question, you can choose a predicate device that is 510(k) cleared or received De Novo grant. Please let me know if this helps!

@slz1119 8 ай бұрын

This helps a lot, thank you so much!@@TheBMELife

@slz1119 3 ай бұрын

Hi, @@TheBMELife , can marketed PMA serve as a predicate device for a 510(k) filing?

@mohamadsuhail966 2 жыл бұрын

Mam is this a good career

@TheBMELife 2 жыл бұрын

Yes!

@amirabaali8079 2 жыл бұрын

Please help me! why this approval is called 510K ??

@TheBMELife 2 жыл бұрын

It’s called 510k because it is actually section 510(k) of the Federal Food, Drug and Cosmetic Act.

@amirabaali8079 2 жыл бұрын

@@TheBMELife Thank you so much, you are a lifesaver

@bhagyeshkhurana9533 3 жыл бұрын

Do you also provide consultancy for registration of 510k

@TheBMELife 3 жыл бұрын

Yes! I currently work as a regulatory affairs consultant! You can reach out to me at meri@thebmelife.con for more information!

@MavenProfconServicesLLP 3 жыл бұрын

Hey Bhagyesh, we are a consultancy working in the same domain. Check out our channel to know more about the same. kzfaq.info/get/bejne/oNmAoc-dt66vm4E.html Here's a link to one of our videos, don't forget to subscribe to our channel to get more updates!