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Did the FDA send you an 'UDI Compliance' email today?
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Several of our clients received an email today from the FDA. The subject line of the letter was "UDI Compliance." The FDA is sending this email out to companies that:
1. are currently registered in the FURLS database
2. have a device that is listed in the FURLS database
3. do not have the listed device identified in GUDID database
There are several possible reasons for this. One possibility is a typo in either of the two databases. The likely scenario is that the company has not entered the required UDI and device information in the GUDID database.
The letter provides the compliance deadlines for each device classification, and since all companies were required to complete the GUDID entries by December 8, 2022, and the companies must be registered in the FURLS database for FY 2023, it is quite easy for the agency to send out emails to 100% of the companies that are not compliant.
Even though Medical Device Academy has a procedure for UDI compliance that is part of our turnkey quality system:
Unfortunately, a procedure is not enough. You actually have to implement the procedure. In addition, you are expected to perform an internal audit to ensure compliance with 21 CFR 830 and 21 CFR 807:
If you received a UDI compliance email, the good news is that it was only an email. If you don't comply quickly, this increases the likelihood of an FDA 483 inspection observation or even a warning letter.
If you are interested in single process audit to make sure that you are compliant with these requirements, or you want an internal audit as a CAPA effectiveness check, please visit our website and request a quote for a remote, single-process audit:
The duration should be approximately 2.5 hours (i.e., $687.50)--including the report writing. However, if you have a large number of records, additional time may be necessary to complete a thorough sampling of records.
1. are currently registered in the FURLS database
2. have a device that is listed in the FURLS database
3. do not have the listed device identified in GUDID database
There are several possible reasons for this. One possibility is a typo in either of the two databases. The likely scenario is that the company has not entered the required UDI and device information in the GUDID database.
The letter provides the compliance deadlines for each device classification, and since all companies were required to complete the GUDID entries by December 8, 2022, and the companies must be registered in the FURLS database for FY 2023, it is quite easy for the agency to send out emails to 100% of the companies that are not compliant.
Even though Medical Device Academy has a procedure for UDI compliance that is part of our turnkey quality system:
Unfortunately, a procedure is not enough. You actually have to implement the procedure. In addition, you are expected to perform an internal audit to ensure compliance with 21 CFR 830 and 21 CFR 807:
If you received a UDI compliance email, the good news is that it was only an email. If you don't comply quickly, this increases the likelihood of an FDA 483 inspection observation or even a warning letter.
If you are interested in single process audit to make sure that you are compliant with these requirements, or you want an internal audit as a CAPA effectiveness check, please visit our website and request a quote for a remote, single-process audit:
The duration should be approximately 2.5 hours (i.e., $687.50)--including the report writing. However, if you have a large number of records, additional time may be necessary to complete a thorough sampling of records.
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Did the FDA send you an 'UDI Compliance' email today?
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