Medical device regulation

The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) is responsible for regulating medical devices. Prior to entry into the US marketplace, many devices require premarket submissions so FDA can evaluate the safety and efficacy characteristics of the device in question. There are several different types of premarket submissions. For many devices, the applicable type of premarket submission is known as a premarket notification, commonly referred to as a 510(k).

Medical devices are separated into risk-based classes as well as product codes depending upon their use patterns and claims. Each type of medical device is associated with a medical specialty (often called a panel). There are 16 specialties and each contains devices meant for specific practices such as neurology or anesthesiology. Identification of the appropriate product code and positioning within that product code can be impactful with regard to overall regulatory obligations and the pathway to market for a given medical device. 

TSG can help

  • Develop and oversee product development plans for 510(k) notifications
  • Submit premarket 510(k) notifications
  • Resolve FDA/EPA jurisdiction issues
  • Develop labels
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