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.

•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 repackager or relabeler, 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
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