How to register a Medical Device with FDA? (510k, PMA, de Novo...)
ฝัง
- เผยแพร่เมื่อ 27 ก.ย. 2024
- ► Webpage: podcast.easyme...
The challenge for Medical Device companies is to understand the different pathways to register their products in a certain region. On this episode, we will focus on the US FDA regulation for Medical devices.
To help us, I invited Michelle Lott from LeanRAQA. She will let you know what are the different steps to consider when you are trying to register a Medical Device in the USA.
We will talk about the product classification, the different registration procedures (510k, deNovo, PMA) and also about the Quality Management System acceptable by the FDA.
After listening to this episode, you will have a minimum understanding to place your product to the US market. But anyway if you need support you can contact Michelle or me to answer your questions.
► Who is Michelle Lott
Michelle Lott is founder and principal of leanRAQA, which has supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, FDA audits, due diligence, technical support services - (and grief counseling, because dealing with regulators can be emotionally draining!).
She has served on the FDA Device Good Manufacturing Practices Advisory Committee and is a vocal advocate of EU MDR readiness. Michelle serves the medical device, dietary supplements, biologics, pharmaceutical, cosmetics, and food industries. She has a weakness for tequila and anything barbecued.
► Links
■ Michelle Lott Linkedin: / michellelottraqa
■ LeanRAQA website: LeanRAQA.com
■ Episode Unannounced Audit: podcast.easyme...
■ Article “510k Substantial Equivalence”: easymedicaldev...
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► Social Media to follow
■ Linkedin: / melazzouzi
■ Twitter: / elazzouzim
■ Pinterest: / easymedicaldevice
■ Instagram: / easymedicaldevice
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#FDA #medicaldevice #compliance
We are a 3PL with our Medical Device Establishment License and we are located in Mississauga Canada
Extremely good content !! Please do a case study of previously FDA approved class 2 medical devices. I want to know the documents etc which others have applied(only for case study purpose).
Is 510k documents needed for ultrasonic dental tartar removal machine?
We need to evaluate the product code for such device. You can try to search for a competitor product on the US database and this will tell you the process to follow. Follow the same as your competitor device.
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?
Sir can u suggest me book about medical device and drug regulation as per fda and Europe
Start giving links from FDA website or EU website in next podcast
Hello, thanks for your content. I want to hear your opinion about the FDA Approval. Is there an FDA in Ecuador? If so, if you register medical equipment in Ecuador and receive FDA APPROVAL, will it be automatically listed in America? I can not find any information on the Internet, or on the site "FDA". if u can write your contact mail/or number - it will be cool. Thank you again!
Thank you for this
Hi Mounir,
At 9:50 she said like exemption of GMP is there for Class I devices in US FDA but this exemption of Quality Management System doesn't exist in Europe, which I think is incorrect. For Class I device (non-sterile, non-reusable and without measuring function), QMS is exempted even in EU MDR. Please let me know if I am mistaken. The overall session was very good and thanks to both of you for sharing your knowledge with us.
asif mukhtar ansari dear Asif, thanks for your comment. In reality if we talk about the necessity to have a Quality Management System, the EU MDR is clear that you need to have one. It is clearly mentioned o. EU MDR article 10(9). I have also made a LinkedIn Live with Stefan Bolleininger for that. So the answer is Yes, you need a QMS even for class I devices.
@@EasyMedicalDevice Hi Mounir, thanks for your prompt response and pointing out this important clause, however if I go to Article 52(7) it says manufacturers of Class I device require Documentation set out in Annex II and III,but it doesn't talk about QMS being mandatory for Class I device. Unfortunately I haven't been through your session with Stefan hence this is my perspective right now. I will definitely go through that session and check if my perspective changes. Thanks
asif mukhtar ansari I understand your point but it doesn‘t say also that it should not follow Article 10(9). Article 10(9) list the minimum requirements for manufacturers when creating a QMS. It doesn‘t ask you to submit that to a Notified Body as said in Annnex IX but it says that you should have one. In 52(7) it does mention the part related to Technical Files as a conformity assessment route but the minimum requirements listed in article 10 are for everyone. If it was not the case, it would have said that class I are exempt of the Article 10 application.
I am big fan of your content , I am telling you ...your content which is online is amazing , Just that your youtube channel need more marketing
Hi Ankit, really appreciate your comment. Happy that you enjoy the content.
Easy Medical Device , Can you make a video on the topic:
1. ISO 14971 vs 13485 vs MDR
2. UDI and EUDAMED
Hi. I'm in Toronto want to sell products In USA how I reach you?
How do I research certification r requirements for facemasks