Thank you there 👀 Mr. Ghandi

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

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 😂

Thank you, kind Mayur!

Our pleasure!

Thank you so much! Glad it was helpful!

Happy to help!

Happy it helped! 😊

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

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

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!!

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

Happy to help!!

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!

😃

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. kzfaq.info/get/bejne/oNmAoc-dt66vm4E.html

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?

Hamza Hajeir Thank you! Really appreciate it 😊

Glad to hear! ☺️

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

I agree! Stepping up the graphics!

Thank you!

@@SanAntonioWedding Indeed! ;)

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.

Thank you!

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

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

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!

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

Please see this website: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm

Hope it was helpful!

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!

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!

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.

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

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. kzfaq.info/get/bejne/oNmAoc-dt66vm4E.html

JAM JAM thank you!

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

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!

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

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

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.

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! 💪🏼👏🏼

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

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

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!

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

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?

🫡

Yes!

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. 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!

Hello, yes! Feel free to email me at meri@thebmelife.com

More coming soon! Check our latest video we just uploaded today :)