Regulatory Open Forum

Hello RAPS Expert,

One of the model we stopped selling almost 2 years ago but unfortunately we didn't submit UDI to GUDID that time.
Not sure, it was compulsory at that time for class I (non measuring, non sterile) medical devices manufacturer. 

Since, our expected device life is 10 years with proper maintenance and replacement of defective parts, i thought it's better to submit UDI to FDA database.

But database is not letting me to do. Any feedback will be appreciated

Anon,

Probably because you can not "back date" the commercial distribution end date.  You could put the Publish Date today and the Commercial End Date as tomorrow - then internally write a note to file about what was done in the GUDID database.  At least in the GUDID database it will show as not in commercial distribution.

Hello RAPS Expert,

One of the model we stopped selling almost 2 years ago but unfortunately we didn't submit UDI to GUDID that time.
Not sure, it was compulsory at that time for class I (non measuring, non sterile) medical devices manufacturer. 

Since, our expected device life is 10 years with proper maintenance and replacement of defective parts, i thought it's better to submit UDI to FDA database.

But database is not letting me to do. Any feedback will be appreciated

Hello RAPS Expert,

One of the model we stopped selling almost 2 years ago but unfortunately we didn't submit UDI to GUDID that time.
Not sure, it was compulsory at that time for class I (non measuring, non sterile) medical devices manufacturer. 

Since, our expected device life is 10 years with proper maintenance and replacement of defective parts, i thought it's better to submit UDI to FDA database.

But database is not letting me to do. Any feedback will be appreciated

Enforcement date was extended to 2022-12-08

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/unique-device-identification-policy-regarding-compliance-dates-class-i-and-unclassified-devices

Hello RAPS Expert,

One of the model we stopped selling almost 2 years ago but unfortunately we didn't submit UDI to GUDID that time.
Not sure, it was compulsory at that time for class I (non measuring, non sterile) medical devices manufacturer. 

Since, our expected device life is 10 years with proper maintenance and replacement of defective parts, i thought it's better to submit UDI to FDA database.

But database is not letting me to do. Any feedback will be appreciated