USFDA Regulation for Class II Devices

 

·       Class II devices are subject to general and special controls, which may include special labeling requirements, mandatory performance standards and post-market safety surveillance.

·       Most Class II devices are approved under a 510(K) premarket notification submission except for devices listed in Reserved Medical Devices.

·       New devices without an equivalent in market are approved through de novo process.

 

 

 

References:

 

1)    Class II 510(K) Exempt

2)    USFDA General Controls for Class I Devices.

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

4)    Labeling Requirements

5)    Registration of Manufacturing Facility & Listing of Devices

6)    Predicate Device

7)    Substantial Equivalence

8)    Third Party Review Program

9)    510(K) Notification

10) Special 510(K)

11) Abbreviated 510(K)

12) De Novo Classification Process

13) Investigational Device Exemption (IDE)

14) Premarket Approval Application (PMA)

15) Expedited Review of Devices Subject to PMA

16) Post-Market Safety Surveillance – Reporting Adverse Events

17) Modifications to Devices Subject to 510(K)

18) Modifications to Devices Subject to PMA