Regulatory Open Forum

IVDs are medical devices in the US, so all of the medical device regulations apply.

Quickly, you will put a UDI on every device. The UDI is composed of a Device Identifier (DI) and any Production Identifiers (PI) that you use. Often people say, UDI = DI + PI. In addition, you must load information into FDA's database, the GUDID.

Standard packaging configurations require a different DI. For example, if you ship kits individually the kit will have a UDI on the label. If you ship 5 kits as a configuration, 10 kits, etc. each standard configuration requires a DI.

The compliance date for Class II devices is Sep. 24, 2016. The compliance date for Class I devices is Sep. 24, 2018.

The bar code is not simply a bar code you develop. It is a bar code that follows the requirements of an Accredited Issuing Agency. At this writing, there are only 3 such organizations.

There are other issues for kits, Class I devices, devices sold at retail, etc. I have not tried to cover them.

IVDs are medical devices in the US, so all of the medical device regulations apply.

Quickly, you will put a UDI on every device. The UDI is composed of a Device Identifier (DI) and any Production Identifiers (PI) that you use. Often people say, UDI = DI + PI. In addition, you must load information into FDA's database, the GUDID.

Standard packaging configurations require a different DI. For example, if you ship kits individually the kit will have a UDI on the label. If you ship 5 kits as a configuration, 10 kits, etc. each standard configuration requires a DI.

The compliance date for Class II devices is Sep. 24, 2016. The compliance date for Class I devices is Sep. 24, 2018.

The bar code is not simply a bar code you develop. It is a bar code that follows the requirements of an Accredited Issuing Agency. At this writing, there are only 3 such organizations.

There are other issues for kits, Class I devices, devices sold at retail, etc. I have not tried to cover them.

I feel good when Sam agrees with me.

I have given you, at best, the top level issues. There is complexity here and it often requires a more detailed analysis of the situation. This is a case in which an appropriate consultant can provide value. For the West Coast, Sam is your first choice. For the East Coast, use Dan O'Leary.

I feel good when Sam agrees with me.

I have given you, at best, the top level issues. There is complexity here and it often requires a more detailed analysis of the situation. This is a case in which an appropriate consultant can provide value. For the West Coast, Sam is your first choice. For the East Coast, use Dan O'Leary.