510k exempt Class I Medical Device - Confusion during the facility registration

B

babarian

Dear All:
would you do me a favor and give some hints:
As a manufacture producing 510k exempt class I medical device, we applied for facility registration and product list after pay 2008$.
We thought we could get facility registration number soon, maybe several days after submission.
However, after submission, it was found it will take 30 ~ 90 days to receive the registation number as cited below:
[FONT=宋体]"As a manufacturer, specification developer, or single-use device reprocessor, you are required to pay an annual fee for medical device facility registration.
You will receive another email providing you with your registration number in approximately 30 to 90 days.
[/FONT]
[FONT=宋体]Until your registration number is assigned, reference your Owner/Operator number in any correspondence [/FONT]
[FONT=宋体]with the Center for Devices and Radiological Health.":bonk:[/FONT]
[FONT=宋体][/FONT]
[FONT=宋体]After consult with FDA officer, they said: "It takes up to 90 days to get a registration number assignment.":mad:[/FONT]
But some experinced companies told me that for just 1 or 2 weeks, they could receive the 510k exempt product registration number. Have FDA policy any change now since it will take much a longer time? Or is there anything I don't know?
Another question is, can we use owner operation number instead of registeration number to sale product during this waiting time?
We are so anxious for your answers and help!

best regards!
Tao
 
M

MIREGMGR

But some experinced companies told me that for just 1 or 2 weeks, they could receive the 510k exempt product registration number.

Your Establishment Registration number is not a product registration number. Your medical device product, not being regulated, will not have a product registration number or any similar FDA recognition.

Mentioning or referencing your Establishment Registration number in your labeling or advertising, or otherwise in your sales and marketing process, as if it indicates FDA approval of your medical device product would be specifically illegal.

Another question is, can we use owner operation number instead of registeration number to sale product during this waiting time?


How is the Establishment Registration number relevant to your distribution and sales process?
 
B

babarian

Miregmgr, thanks for your concerns and help.
Your Establishment Registration number is not a product registration number. Your medical device product, not being regulated, will not have a product registration number or any similar FDA recognition.

Mentioning or referencing your Establishment Registration number in your labeling or advertising, or otherwise in your sales and marketing process, as if it indicates FDA approval of your medical device product would be specifically illegal.

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thanks for your reminding, and I noticed it. Currently, what we are doing is for facility estabilishement registration and product list. No 510k or PMA is needed since our product is 510k exempt.
My question is why the online establishment registration will take such a long time to be approved. It is not for product clear, just for manufacture establishment registration.

How is the Establishment Registration number relevant to your distribution and sales process?
Have class I product listed, the product is allowed to be sold to U.S then. If the Establishment Registration number is available, our customer can search it from database then and it is also evidence of facility registered.
 
M

MIREGMGR

I'm not aware of a workaround for the FDA's typical timelines for various actions.
 
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