Drugdu.com expert's response:

I. Which combination products does the FDA regulate? First, clarify the scope

The FDA's UDI rules primarily target medical device components, but combination products (such as drug - device combinations or device - drug co - packaged products) need to be treated differently based on their types. In simple terms:

If the device is the main function in a combination product (for example, a drug - eluting stent, where the core is the stent): It must be labeled with a UDI, and the drug's NDC code cannot be used as a substitute.

If the drug is the main function (for example, a prefilled syringe, where the core is the drug inside): If it has already been labeled with an NDC code, the device part does not need to be additionally labeled with a UDI (but if the device components are sold separately, they still need to be labeled with a UDI).

Co - packaged products (for example, a surgical kit with accompanying drugs): The overall packaging only needs to be labeled with a UDI, and the device components inside do not need to be labeled separately (unless the components are sold separately).

Cross - used products (for example, a blood glucose meter and test strips): Both need to be labeled with UDIs, and the instruction manual should clearly state how they are used in combination.

II. What exactly should be labeled with a UDI? Two key parts

A UDI is not just any random code; it must contain a fixed part (DI) and a variable part (PI):

DI (Device Identifier):

It is equivalent to the product's "ID number," including enterprise information, model version, etc.

For example, the DI of a certain brand of heart stent might be "12345 - 67890," and this code never changes.

PI (Production Identifier):

It contains dynamic information, such as batch number, serial number, expiration date, and production date.

For example, the PI for the same batch of stents might be "Batch number A202301, expiration date 2025 - 12."

How to label?

It must be directly printed on the product (such as through etching or labeling), and cannot be just placed in the instruction manual.

For reusable devices (such as surgical forceps), they can be labeled on the packaging, but it must be ensured that the information can be retrieved before each use.

III. Where should the data be submitted? The GUDID database

All products labeled with a UDI must submit their DI and PI information to the FDA's Global Unique Device Identification Database (GUDID). The specific operations are as follows:

Find a code - issuing agency: The FDA has authorized three agencies (GS1, HIBCC, ICCBBA). Choose one to apply for a UDI code.

Submit data: Upload the DI, model number, enterprise information, etc., through the GUDID system (the dynamic information in the PI does not need to be submitted every time, but it must be able to be associated).

Who should submit?

It must be the "labeler" of the product (such as the brand owner), not the supplier or distributor.

If you purchase components that have already been labeled with a UDI by others, you need to confirm that the supplier has submitted the data.

IV. When can exemptions be granted? Not all products need to be labeled

The FDA also provides some "exceptions," but the conditions are quite strict:

Low - risk devices: For example, Class I devices (such as examination gloves), if the risk is low and the use is simple, an exemption can be applied for.
But if they have already been labeled with a UPC code (the kind of barcode used in supermarkets), it is also considered compliant.

Combination products already labeled with an NDC: If the drug is the main function in a combination product and it has already been labeled with an NDC, the device part does not need to be labeled with a UDI (but if the device components are sold separately, they still need to be labeled).

Technically unable to label:

For example, if the product is too small (such as a micro - implant) or labeling a UDI will affect its performance, a special exemption can be applied for, but it must be proven that "it is really impossible."

V. What should be noted in practice?

Don't confuse UDI and NDC: A UDI is the "ID card" of a device, and an NDC is the "ID card" of a drug. The two cannot be substituted for each other (unless explicitly allowed by regulations).

The supply chain should cooperate: If you purchase components that have already been labeled with a UDI by others, you need to confirm that the supplier has submitted the data to the GUDID; otherwise, you may be subject to inspection.

Dynamic information should be accurate: The batch numbers, expiration dates, etc., in the PI must be consistent with the actual production records; otherwise, it may be regarded as "data fraud."

Keep an eye on FDA updates: The UDI rules are regularly adjusted (for example, new exemption conditions are added). It is recommended to regularly check the FDA's official website or participate in industry conferences.