New FDA Guideline on Product Classification - what is a Drug, what isn't?

The new FDA guideline titled "Classification of Products as Drugs and Devices and Devices and Additional Product Classification Issues: Guidance for Industry" describes on 12 pages how the FDA classifies products as drugs, medical devices or other.

As written in the introduction of the guideline, the FDA saw the need to publish this guideline because of questions about product classification. Target groups are the industry and the FDA itself. The guideline was published by the Office of Combination Products (OCP) in coordination with CBER, CDRH and CDER. In this case, classification does not mean categorising medical devices into class I, II or III, but a classification into drugs, medical devices or combination products. The guideline refers specifically to cases where it has to be decided whether a product is a drug or a medical device.

The guideline is divided into two sections: first, a section on obtaining a formal classification determination for a product, and then a section on what the FDA considers in determining whether to classify a product as a drug or a device.

The procedure to obtain a formal classification is actually quite simple. A request for classification is submitted to the OCP. The applicant has to include a justified self-classification of the product however. The FDA will reply within 60 days - or not. In the case of no answer, the self-classification is deemed accepted.

What does the FDA consider in order to classify a product as a drug or medical device? In this section, the guideline explains definitions of drugs and medical devices and then focuses on the details of defining medical devices.

Then examples for the classification of drugs and medical devices are listed in a table. A subchapter explains how to classify a product which is defined both as drug (and possibly medical device) and as biological product. The document ends with a Q and A section.

To find further details please see the guidance "Classification of Products as Drugs and Devices and Additional Product Classification Issues" itself.

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