Division of Clinical Research

Office of the Vice President and Innovation

The Center for Devices and Radiological Health (CDRH) posted new updates on FDA.gov on December 17, 2019.

The How to Determine if Your Product is a Medical Device page discusses the steps when trying to determine if a product is regulated by the FDA as a medical device and include:

  • Step 1: Determining if your product meets the definition of a medical device per Section 201(h) of the Food, Drug & Cosmetic Act.
  • Step 2: Determining if an appropriate product classification exists for your product
    • Method 1: Search the Product Classification Database
    • Method 2: Search for Similar Devices
    • Method 3: Search for Similar Devices by Device Listing

Other considerations are discussed for Mobile Medical Applications, Software as a Medical Device, products intended for General Wellness, and combination products.

For more information:

Categories FDA Regulatory
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