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