Chapter 20 - medical device submissions Flashcards
1
Q
What is FDA Intercenter Agreement with CBER
A
according to 31 October 1991 CBER is responsible for medical devices related to blood and cellular products
2
Q
what are the 4 most notable changes of SMDA 1990 and MDA 1992
A
1-Introduction of Humanitarian device exemption similar to orphan drug but with 4000
2-new quality laws for GMPs of medical devices QSR
3-establishing regulatory requirements which require manufacturers to report any field corrections and removals.
4-introduction of device tracking registration
3
Q
what is QSR
A
Quality system regulations - GMP requirements for devices, though some devices are exempt for the regulations they are never exempt from QSR
