FDA Web Update: How to Determine if Your Product is a Medical Device

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:

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