FDA Establishment Registration and Listing for Medical Devices
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- เผยแพร่เมื่อ 14 ก.ค. 2021
- Do you need help with completing your initial FDA establishment registration and listing for a medical device? Watch our video to learn how.
The two most common situations for when a company needs to register their establishment with the FDA is 1) when the company is a contract manufacturer and producing a finished device for the first time, and 2) when the company is a specifications developer that recently received a 510(k) and is about to begin distribution of the newly cleared product. If your company is a specification developer, and you have not yet submitted your first 510(k), then you need to complete your Medical Device User Fee Cover Sheet first. If you have already received 510(k) clearance, or your device is exempt from 510(k) clearance, this article and the associated video will help you complete your FDA establishment registration and listing.
In this video we walk you through the process for accessing the two websites and we identify the most common pitfalls. If you would like to hire us to help you complete the FDA establishment registration process, please use the following calendly link: calendly.com/13485cert/regist...
You might also be interested in our blog on this topic:
medicaldeviceacademy.com/fda-... - วิทยาศาสตร์และเทคโนโลยี
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awsome i got it! I just thank you for you video. Greetings from México
Glad it helped!
Thanks for this info! What happens if I have a Class I medical device that has different parts made with different manufacturers? Does each facility that touches any part of it have to pay the FDA registration fee? Or just one of them?
A very similar questions was asked on our website. Here's the response copied from that page: "Many companies think they are not required to register with the FDA as a contract manufacturer for various reasons. If your company is a contract sterilizer or your company is making a finished device, you must be registered-regardless of where you are shipping it initially. In your example you mentioned three manufacturers. If they manufacturers are making components, they are not required to register. If they manufacturers are making accessories or finished devices, they are required to register. If two component suppliers ship to a third supplier that does final assembly and packaging, then only the final assembly company is required to register."
Thank you so much for the informative video!!! Should a new company pay both the annual registration charge and the 510k submission fee in order to submit a 510k before October (FY23)?Furthermore, the annual registration cost paid before October (FY23) is it only valid through September 30 (FY23) and does it need to pay another annual registration fee for FY24 (Oct-Sept)?
This is an important question to get right.
If you have no products in distribution in the USA, you do not have to register with the FDA. When the DFUF website asks you if your registration payments are all paid, you should answer "Yes," because they don't have an "Not Applicable" option. If you have products in distribution, you must be registered. If it is Oct 1 - Dec 31, you will need to pay your registration for the new fiscal year before you can pay and submit your 510(k).
Your last sentence is correct that registration user fees paid before October 2023 are only valid until September 30, 2023 for FY 2023, and there is no prorating of registration user fees. You will need to pay the FY 2024 user fee for registration after October 1, 2023.
If you pay the 510(k) user fee for FY 2023, but you are not ready to submit until FY 2024...then you need to file a transfer form or request a refund.
Thank you very much for your amazing video. It is really very helpful as usual. I have one question.
If we are a manufacturer in a foreign country and we have our 510k clearance product registered and listed. Then we have 4 products class 1, 510K exempted and we would like to register them, should we pay 5546 US dollars registration fees once for them all? or we have to pay 5546 for each one separately and the total will be around 22000 in this case?
My apologies for the delayed response Mohammed. I have been on vacation celebrating my 50th birthday. You may have as many products as you wish under the same registration and listing. The registration is for a single facility--not a single product. However, if you have multiple facilities then you need to register each facility. Typically a warehouse is not considered a separate facility. The bottom line...you only pay the fee once ($5,672 for FY 2022).
@Medical Device Academy
Hi Rob
Thank you very much for your reply and happy birth day !
Thank you for a great video! If a foreign establishment is acting as both a "manufacturer" and a "foreign exporter" should they list both of these roles under their FDA registration? Is a manufacturer only able to assist with exportation if they are listed as "foreign exporter" under their registration or is it sufficient for them to be listed as only a "manufacturer". Thanks very much for your assistance in advance!
Great question Hayley. Sorry for the delay. My trip to California set me back a little.
Make sure that when you are thinking of "foreign exporter" you are thinking from the perspective of the US FDA. Foreign exporters are companies in the USA that are exporting to other countries. If you are a manufacturer in another country that ships to countries other than the USA, that is not a foreign exporter. In that scenario you are only manufacturer. You will also need an initial importer to import your devices into the USA as a manufacturer outside the USA.
If you are located in the USA, and you are shipping within the USA to US customers and shipping outside the USA to foreign customers, then you would register as a foreign exporter and manufacturer. You need to be careful of the foreign export requirements. The FDA has specific rules about exporting products not cleared or approved for sale in the USA.
@@MedicalDeviceAcademy hello, my facility counts as foreign exporter and manufacturer. Where can I find more info about the foreign exporter requirements you mention in your last paragraph of this reply? Or if it's not too much, what would these requirements be?
@@MedicalDeviceAcademy Here is the FDA definition of a foreign exporter:
Foreign Exporter - Exports or offers for export to the United States (U.S.), a device manufactured, prepared, propagated, compounded, or processed in a foreign country, including devices originally manufactured in the United States. A foreign exporter must have an establishment address outside the U.S.
Thank you very much for a wonderful video! We just got a 513g letter from the FDA, it's says that our product a 510 (k) exempt class 2 device. Can we start the registration and listing before completing the QS? Will it bring more value to the company for being a specification developer than an initial importer? The company did give a lot of requirements.
I'm glad you found the video helpful. You can register your company and list your device to begin selling. However, you are expected to be 100% compliant with 21 CFR 820, 803, 806, 830, and 7 at the time of registration. You are not required to have ISO 13485 certification by the FDA at this time. Since it is near the end of FY 2023, you probably will want to wait until October 1 to register for FY 2024. There is no prorating of the FDA User Fees. The specifications developer is responsible for maintaining the DHF in accordance with 21 CFR 820.30, while the initial importer does not have QMS requirements other than distribution records. If you would like to discuss this further, please schedule a call with one of our consultants.
How can I change the us agent? I don't have any contact with them anymore and I will update my listings information. Thank you. Your video is awesome
In order to update the US agent you go into your FURLS account and change the contact for the US Agent. The new agent will then need to confirm. Let us know if we can help further, and glad you liked the video.
Thank you so much for such helpful video. I just got one quick question: My company is located in U.S. and have the address can receive letters or packages, but my company is not a legal entity, can my company be the U.S. agent for the company that is located in China to register FDA? Thank you again.
When you create your FURLS account for the US agent business, you will need to enter a business name but there is no requirement for an EIN and the DUNS number is optional. I could not find any requirement for incorporation. Therefore, I don't see any problem with you having a sole proprietorship as your company. I also added a screen capture of the account creation screen to our blog on this topic: medicaldeviceacademy.com/fda-us-agent/
Thanks for the video. Still today very useful. 👍
Only problem I'm facing is, that I have to enter any products at the end of the "register an new medical device facility". But I do not have any products registered yet. I need the establishment registration number for the 510(k) submission. This is confusing
Hi Christian, The FDA does ask what your registration number is. However, if you are not registered then you state "The sponsor does not yet have any products for sale on the US market." There is no requirement for a US Agent or Registration until you are ready to begin selling the product.
@@MedicalDeviceAcademy thank you for your answer. I somehow thought I have to have the establishment registration number for the 510(k). I don't delete the question maybe someone will stubble upon this video with the same issue.
One again, thank you
Good Day! First I would like to thank you for the great video this is truly very informative. My question is what do you do next after Facility Registration and listing for:
A. product that are "510K exempt"
B. product that are "Preamendment"
What are the other requirements for the following in order for the product to be listed in the US FDA Database?
That's a great question too. Any products that are 510k exempt you will be entering the 3-letter product code and the system will not require you to enter a K-number for the listing. For preamendment devices, the device product classification may fit into the exempt group or it may require a 510(k). It just depends on the code.
Hi, I have already registered company with its class 1 device. I need to add additional device which is a newer version of the current device and it is class 1 too. Which process do I need to take? thx
Since your company is already registered, and your first device is already listed, then you just update your listing. You can add the newer version as a brand name to the same listing.
Thank you for this info. I updated the excel file but can not find how to upload it. Is it under the "change" option?
we are in Pakistan. can we pay MDUFA by PayPal ?
The FDA User fees can only be paid on the DFUF website via credit card or ACH transactions from a US Bank. However, there are other instructions for other types of payments. PayPal is not an option.