What makes a medical device a medical device? New FDA guideline on product classification

On twelve pages, the new FDA guideline entitled "Classification of Products as Drugs and Devices and Devices and Additional Product Classification Issues: Guidance for Industry" describes how the FDA classifies products as drug products, medical devices or others.

According to the guideline's introduction, the FDA deemed it necessary to publish this document due to questions concerning the classification of products. The target group consists of the industry and the FDA themselves. The publisher is the Office of Combination Products (OCP) in accordance with CBER, CDRH and CDER. Classification in this case does not mean the categorisation of medical devices into classes I, II and III, but the classification of whether a product is a drug product, a medical device, a biological product or a combination product. The guideline particularly refers to cases in which it is to be determined whether a product is a drug or a medical device.

The guideline is divided into two parts, "What is the process for obtaining a formal classification determination for a product?" and "What does the FDA consider in determining whether to classify a product as a drug or device?"

The procedure of receiving a formal classification is usually quite simple. The OCP is asked for a classification. However, the applicant must submit a justified self-classification. The FDA will then answer within 60 days - or not at all. If that is the case, the self-classification can be considered as accepted.

What does the FDA consider when classifying a product as drug or device? Within this part, the FDA outlines definitions for drugs and devices. It then discusses the definition of medical devices in detail.

The guideline then lists a table of examples for classifications of drugs and devices. A subchapter illustrates the classification of a product which fits the definition of a drug product (and medical device, where applicable) and a biological product. A question and answer part concludes the document.

Further details can be found in the "Classification of Products as Drugs and Devices and Additional Product Classification Issues" guideline itself.