The UDI application required by the FDA may be considered an easy and fast task, which simply requires affixing a barcode on the device. But this is not the case.
This operation does not end in two minutes and must be properly considered by the company that intends to keep on marketing in the USA in the near future.
The UDI program can indeed be considered as one of the most significant regulatory changes introduced in the last few years by the FDA (perhaps you are also interested in “USA: wake up … FDA is talking!“) and it should not be underestimated. Here we will try to explain why, in the knowledge that this is a difficult and complex topic that cannot be described in a nutshell.
The UDI program is not only affixing a barcode but it requires further more complex compliance such as including data into the GUDID database, an FDA-designed tool for tracking and tracing all devices placed on the US territory and how the impact on the quality system is challenging for Italian companies that are already failing to comply with 21 CFR requirements.
This important change should be considered as a real internal project and even managed with a specific preventive action, in order to address all aspects of the activities to be carried out and involve all relevant business functions.
The first aspect to consider in all activities to be implemented is planning, a term not so in line with the Mediterranean personality, but essential to do things properly and in time.
The FDA provides deadlines to market devices complying with the Program, depending on the device type and class (including software with some exceptions):
- Class III devices and devices registered according to the PHS Act, September 24, 2014;
- Implantable Class II devices or life support devices, September 24, 2015; ·
- Class II devices, September 24, 2016;
- Class I devices, September 24, 2018.
Here are the topics to be considered in terms of activities to be managed and implemented:
- Applying UDI on devices and their packaging.
The UDI is the result of two factors combination:
- Device Identifier (DI): it identifies the labeler (the person affixing the label) and the device model;
- Production Identifier (PI): it identifies for example the batch number and/or series, the device expiry and production date. The identifier must be included both on the label and on its packaging according to formal rules clearly stated.
Entering data in the GUDID database
The Global Unique Device Identification Database (GUDID) collects fundamental information to identify the devices circulating in the US market. The labelers or their delegates, who must insert the information in the database, should apply for an account to complete the activity. At the moment, only the DI insertion is provided.
Impact on the company Quality System
The program really affects the company Quality System. Taken for granted, though often this is not the case, the U.S. cGMP (21 CFR 820) implementation in the company, including the Code reference parts (such as 803, 806, etc.), there are several processes that need to be revised to comply with the new provisions.
Consider, for example, the design process (820.30), labelling (801), reporting activities (803), recalls (806), but also traceability requirements (821) and post-market surveillance (822). It is therefore recommended to analyze the entire system in order to implement its content with new references.
Therefore, the final recommendation is not to underestimate the project or delay the implementation, so that you won’t risk to block the marketing or the recall activities for default. There are several FDA guidelines that can be consulted on the subject and they try to provide as far as possible a complete support to understand and implement the new requirements.
As usual, the FDA never fail to give a concrete support.
Have you read “FDA audits: what are the effects on the company?“?
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Marisa Testa
QA/RA Manager
