510(K) is required under following conditions.
- Introducing a device into commercial distribution for the first time
- 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
- 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.
- Device is not marketed or commercially distributed
–Example: clinical trials (regulated by 21 CFR 812) - Distributor of another firm’s U.S.-manufactured device
- 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”
- 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
- Device in commercial distribution before 5/28/76 : Must be documented