Is Training Material Considered Labeling - FDA 21 CFR 801

[fialor]

Hi,
As part of the product we place on the market, audit visual and hard print materials are provided.

The audio visual is available online via our website for the public, clinicians and distributors to access. The hard print is only used as training material when a user/clinicians are trainined.

My question:
Are both considered labelling by 21 CFR 801?
Both are used to teach users how to use the device properly and are used in the delivery of training.

Thanks for reading.
Fialor

 

[QAengineer13]

Hi Fialor,

The short answer to your question is YES, those material are considered as Labelling by the FDA. For your reference, I have attached the Labeling , Regulatory Requirement for Medical Device, FDA 89-4203. Have a read of this document and if you look at the Sample of Approval Form for Labelling, advertising Literature etc....43 its demonstrates that the Training and Education is part of the Labelling.

Hope this helps. For some technical reason, I wasn't able to upload the FDA guidance, if you google you will be able to find it online.

 

[fialor]

Thank you QAEngineer.

 

[Ajit Basrur]

Hi Fialor,

The short answer to your question is YES, those material are considered as Labelling by the FDA. For your reference, I have attached the Labeling , Regulatory Requirement for Medical Device, FDA 89-4203. Have a read of this document and if you look at the Sample of Approval Form for Labelling, advertising Literature etc....43 its demonstrates that the Training and Education is part of the Labelling.

Hope this helps. For some technical reason, I wasn't able to upload the FDA guidance, if you google you will be able to find it online.

Here it is https://www.fda.gov/downloads/Medic...onandGuidance/GuidanceDocuments/UCM095308.pdf

In addition, refer to these links for additional information:

FDA: Label Requirements for General Purpose Reagents IVD

FDA labeling Requirements and Company Brochures and Website Content