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.
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!
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?
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!
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.
Hi, is that what you would call an ultrasonic scaler? "An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth." If so, this falls under the FDA product code ELC, under regulation 872.4850. It is a Class 2 device that does indeed require a 510(k) submission before you can market the device. www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?id=ELC Hope this helps!
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?
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
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?
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.
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?
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!
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. ruclips.net/video/jsPnllRHKkM/видео.html
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! 💪🏼👏🏼
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
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!!
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!
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?
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
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!
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. ruclips.net/video/jsPnllRHKkM/видео.html
Hey Bhagyesh, we are a consultancy working in the same domain. Check out our channel to know more about the same. ruclips.net/video/jsPnllRHKkM/видео.html Here's a link to one of our videos, don't forget to subscribe to our channel to get more updates!
Absolutely fantastic work! Thank you very much! -fellow BME from Singapore
Thank you so much for the support 😊 Greetings to Singapore!
Hi Mam please can you help me my name is MOSAROF I'm from Bangladesh I'm 35 year old I'm suffering MND ALS disses one year please can you help me
I see you’re stepping up the quality, keep it up!
Thank you there 👀 Mr. Ghandi
Smith Jeffrey Jackson Donald Hall Michael
Girl is beautiful.
I’m trying to bring a medical device to market and could use your help.
Hello! Thanks for reaching out. Please feel free to contact me with more details to meri@thebmelife.com
how to check if which Lasers are approved in Canada
This was highly interesting for a biomedical researcher's point of view!
And about that video quality though... ;)!
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 😂
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.
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!
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?
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!
Could please provide link for list of devices which are exempted from 510k submission
Please see this website: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm
Is there an existing menstrual cup brand with the name "Puddle Cups" or any similar variation that is already registered with the FDA?
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.
This is exactly what I wanted to know. Thank you very much kind lady..! :)
Thank you, kind Mayur!
Is 510k documents needed for ultrasonic dental tartar removal machine?
Hi, is that what you would call an ultrasonic scaler? "An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth."
If so, this falls under the FDA product code ELC, under regulation 872.4850. It is a Class 2 device that does indeed require a 510(k) submission before you can market the device. www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?id=ELC
Hope this helps!
Hi, madam, if I want to market a class I medical device, do I need to submit any dossier to the FDA?
It depends! Some Class I devices do require 510(k) submissions.
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?
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
Name of the music, please!
Nice but music is distracting, please no music is needed here
🫡
#HealthyMeals #FDACertifications #Food #Nutrition #Ingredients #IntelligenceAwareness #America
😃
Link please for medical devices list according to FDA regulatory class devision
Hi, question... For personal lube, I was advised for 510k. what category would that be?
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=NUC
let me know if you have more questions!
@@TheBMELife Thank you so much!
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?
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.
@@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?
Who is the person responsible for submitting the CTA to FDA the clinical trial manager?
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?
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!
Okay, thanks for the reply. Great channel.
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.
ruclips.net/video/jsPnllRHKkM/видео.html
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?
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! 💪🏼👏🏼
Thanks for this informative video
Glad it was helpful!
Hi .. what could be the pathway for a acupressure mat.. I guess that is class 1
where is the link to the list you talk about at 1:35?
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm
Please help me! why this approval is called 510K ??
It’s called 510k because it is actually section 510(k) of the Federal Food, Drug and Cosmetic Act.
@@TheBMELife Thank you so much, you are a lifesaver
Very understandable! Thanks you very much
Happy to help!
Amazing video! So informative!
Glad it was helpful!
How to LST number for sanitary pads
What about DeNovo devices?
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
May I ask you how to check the medical application online? We applied it last December to FDA . Thank you
What application are you referring to? Feel free to email me to discuss more details meri@thebmelife.com
wow how old are you and you know all this information!? This was very helpful, exactly what I was looking for. Thank you!
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!!
Can a class III medical device claim for substantial equivalence to a predicate device under 510(k)?
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.
Hi! Great video
How can substantial equivalence proved for a novel device of class ll if it has a low risk
Depends on the device.. Feel free to email me with more details meri@thebmelife.com
Are all 510(k) medical devices predicate devices?
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!
This helps a lot, thank you so much!@@TheBMELife
Hi, @@TheBMELife , can marketed PMA serve as a predicate device for a 510(k) filing?
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?
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
Thank you for good session.
Our pleasure!
The t-shirt is way too cute!
😯 😎
Hi there! Great content! Thank you! Wondering how are general wellness devices cleared? Thank you
Please refer to FDA's guidance document for General Wellness devices: www.fda.gov/media/90652/download
Thank you very much very helpful.. 👍☺️
Glad to hear! ☺️
Great video, you solved a lot of my doubts!
Happy to help! Let me know if you have any concerns or questions I could help with.
Thank you for the information and the clarity 💐💐💐👌👌👌
Happy to help!!
nice
Hope it was helpful!
Is there a reason you didn't go over De Novo?
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!
Outstanding, useful video, I except you can do more videos in this Regulatory domain
Thank you! More to come! :)
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.
ruclips.net/video/jsPnllRHKkM/видео.html
Do you also provide consultancy for registration of 510k
Yes! I currently work as a regulatory affairs consultant! You can reach out to me at meri@thebmelife.con for more information!
Hey Bhagyesh, we are a consultancy working in the same domain. Check out our channel to know more about the same.
ruclips.net/video/jsPnllRHKkM/видео.html
Here's a link to one of our videos, don't forget to subscribe to our channel to get more updates!
thank you. very informative. simple and clear.
Hi Dileep! Glad you found this helpful. Let me know if I can assist you in any way.
U r so cute
Thanks you very much please i am following you i hav idea and i learned from you
Glad we could help! 😊
@@TheBMELife I am looking to hire someone to submit 501k application ? Do u provide this service or know someone who do ?
@@MB-qz7xb Yes! I work at a regulatory and quality consulting firm. Feel free to email me to meri@thebmelife.com to connect!
Nice quality 10/10
I agree! Stepping up the graphics!
Thank you!
@@SanAntonioWedding Indeed! ;)
Simple and effective 👌🏻
Glad you enjoyed our video! Please don’t hesitate to let us know if there are any specific topics you’d like for us to cover next.
Mam is this a good career
Yes!
Love you!
Well done! That was so easy to understand!
Thank you so much! Glad it was helpful!
Can we get connected.
Hello, yes! Feel free to email me at meri@thebmelife.com
Never seen such a clear explanation!
Happy it helped! 😊
Very helpfull video!
I’m glad you found it helpful, Nick! 😊 Thank you for the feedback.
Nice !
Thank you! Please let me know if you have any questions.
Nice and well organized content !
Hamza Hajeir Thank you! Really appreciate it 😊
Wonderful job!!
Thank you!
Very nice video
JAM JAM thank you!
Still waiting for more content
More coming soon! Check our latest video we just uploaded today :)