Nicotine gum is a product used by smokers to try to stop or limit smoking. It delivers doses of nicotine through the oral mucosa to help reduce smoking withdrawal symptoms The person is instructed to chew the gum intermittently to allow the nicotine to be absorbed gradually.

Nicotine gum is a combination product as it combines the drug component which is nicotine to the device component which is the gum matrix allowing the controlled release of nicotine. This allows it to be classified as a drug-device combination product regulated through the drug pathway.

As this is an Over The Counter drug, it cannot be classified as a device, but if it were, it would likely be Class I as there is only low risk to utilizing it.

For FDA approval, this follows the drug approval pathway which starts with preclinical testing. Eventually it will move to clinical trials for safety and efficacy. Afterwards, a new drug application must be submitted to the FDA guaranteeing safety, effectiveness, and quality. Once approved, this product will undergo post-marketing surveillance.

An example of a combination device is an epinephrine auto injector, such as an EpiPen. This is a combination of a drug and a medical device used to inject epinephrine into an individual experiencing an allergic reaction to ease breathing through opening the airway. This product is generally classified as a Class ll medical device because it poses a moderate level of risk to patients and special controls to ensure safety and efficacy. There are a number of steps a company must go through before it can be approved by the FDA to be sold to consumers. First, the FDA must decide on the products mode of action to decide whether it is a drug or a device. The company must also show the FDA test results to show safety and efficacy and adhere to a series of quality manufacturing and file a 510(k) premarket notification to be approved by the FDA before it is allowed to be sold to consumers.