Is my Product a Medical Device?

Under FDA’s governing statute, the Federal Food, Drug, and Cosmetic Act (FDCA), a device is “an instrument, apparatus, implement, machine, contrivance, implant, or in vitro reagent” that “is intended for use in the diagnosis of a disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.” Unlike drug products, devices do not achieve their intended use by chemical action in the body and are not dependent on metabolism. Because of this definition, many diagnostic tests, genetic and genomic tests, and digital health technologies are considered devices. With improper claims, wellness products can also be considered devices by the FDA.

How are Devices Regulated by FDA?

FDA’s regulations classify devices into three regulatory categories by risk.  The risk level of a device is generally determined by its intended use, the technology used in the device, and/or whether there is a similar device already on the market. 

Most commonly, FDA classifies devices that present a low risk of injury or illness when used as Class I and devices that present a moderate risk as Class II.  Class III devices are generally considered high-risk devices, i.e., those that pose significantly greater risks to patients.  However, a device that presents new technology, and that is not similar to any device already on the market, is automatically classified into Class III.  The higher the device classification, the more FDA regulations the manufacturer must follow, and the longer the statutory timeline for the device to be legally marketed. 

Will my Device be Subject to FDA Review?

FDA has promulgated extensive device regulations, which include requirements and specific quality controls for clinical investigations, manufacturing, distribution, and labeling. Most Class II and Class III devices cannot be legally marketed without going through FDA’s premarket review process: 510(k), De Novo,  or PMA. Though these pre-submission processes have prescribed procedures and timelines, each device can present unique issues that may delay FDA’s review. It is not unlikely for FDA’s review process to extend beyond the prescribed time frames.

Penn Avenue Law & Policy Can Help You Navigate the FDA Process

Experienced counsel can help you navigate the FDA’s regulations, guidance, and policies during every phase of a device’s life cycle. Christine P. Bump advises clients on clinical investigations, premarket submissions, pre- and postmarket compliance, and promotional issues. She has extensive experience developing regulatory strategies that are appropriate for both your product and your company’s business goals.

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