USFDA Regulation for Class I Devices

 

·       Class I devices are subject only to General Controls.

·       Almost all Class I devices are exempt from 510(K) premarket notification except for devices listed in Reserved Medical Devices.

·       Premarket notification is also required for new devices without an equivalent in market.

·       Few Class I devices are exempted from GMP requirements.

 

 

 

References:

 

1)      USFDA General Controls for Class I Devices.

2)    GMP Exempted 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