When do we need 510(K) ?

510(K) is required under following conditions.

  1. Introducing a device into commercial distribution for the first time
  2. Different intended use for a device already in commercial distribution
    • Indicated by claims made for a device in labeling/advertising
    • Note: Prescription use to over-the-counter use is a major change in intended use
  3. Change to a device that could significantly affect its safety or effectiveness
    • Burden is on you to decide whether a modification “could significantly affect safety or effectiveness.”
    • If no submission, justification should be recorded in your change control records

510(K) is not required under following conditions.

  1. Device is not marketed or commercially distributed
    –Example: clinical trials (regulated by 21 CFR 812)
  2. Distributor of another firm’s U.S.-manufactured device
  3. Device is not manufactured by your company, but is marketed or commercially distributed by your company : Labeling shall reveal connection with manufacturer: “Manufactured for Life-Tech” or “Distributed by Life-Tech”
  4. For re-packager or re-labeler, if labeling or condition of the device is not significantly changed : Labeling must be same as 510(k): indications for use, warnings, contraindications
  5. Device in commercial distribution before 5/28/76 : Must be documented