Medical Devices

Background

The medical device industry is rapidly developing with more and more devices entering the market each year. FDA’s Center for Device and Radiological Health (CDRH) is the primary center within the FDA responsible for medical device regulation and oversight. Pathmaker FDA Law has extensive experience working with FDA to get our clients’ devices to market by tailoring unique approaches for each devices.

We represent a wide variety of medical device firms, from start-ups to well established players. Whether you are a manufacturer, distributor, or importer, we have the knowledge and flexibility to get your device to market. 

Regulatory Scheme

In the United States, FDA regulates devices into three classes: Class I, Class, II, and Class III. These classes generally correspond to the risk to the patient and/or the user of the device with Class I is the lowest risk and Class III is the highest.

Class I devices generally have few barriers to entry as they are low risk. Some examples would be a band-aid or a toothbrush. Class II devices are medium risk and typically require FDA clearance. Examples include surgical needles and surgical masks. Class III devices are the highest risk, usually being life sustaining or pose significant risk of illness or injury, requiring FDA approval. Examples include pacemakers, defibrillators, and breast implants.

Path to Market

The cost and speed of getting a device to market is very dependent on its class.

 

Class I Devices

Class I is synonymous with general controls. General controls are the only levels of controls that apply to Class I devices. General controls are basic requirements such as ensuring devices are prepared, packaged, and stored in sanitary conditions. Approximately 47% of all medical devices fall under this class.

 

Most Class I devices do not require any kind of FDA approval to be marketed, but some do require a 510(k)

Class II Devices

Class II medical devices include devices that have a moderate to high risk to the patient and/or user.