USFDA Regulation for Class III Devices

 

·       Class III devices are subject to general controls, special controls and pre-market clearance.

·       Most Class III devices are approved under approved under a pre-market approval (PMA) procedure.

·       New devices that are not classified as Class I or II are automatically designated as Class III unless the manufacturer files a request or petition for reclassification (de novo).

 

 

 

 

References:

 

1)    Predicate Device

2)    Substantial Equivalence

3)    Third Party Review Program

4)    510(K) Notification

5)    Special 510(K)

6)    Abbreviated 510(K)

7)    Investigational Device Exemption (IDE)

8)    Premarket Approval Application (PMA)

9)    USFDA General Controls for Devices

10) Quality System Regulation (QSR)/ Good Manufacturing Practices (GMP)

11) Labeling Requirements

12) Registration of Manufacturing Facility & Listing of Devices

13) Expedited Review of Devices Subject to PMA

14) Post-Market Safety Surveillance – Reporting Adverse Events

15) Modifications to Devices Subject to 510(K)

16) Modifications to Devices Subject to PMA