RAC US Devices Exam Questions and Answers All Correct
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Course
RAC US Devices
Institution
RAC US Devices
RAC US Devices Exam Questions and Answers All Correct
What is a device recall? - Answer- generally a voluntary action by sponsor
can be requested by FDA
likely need to report to FDA
device recall classes - Answer- class 1: use will cause serious adverse health consequences
class 2: ...
RAC US Devices Exam Questions
and Answers All Correct
What is a device recall? - Answer- generally a voluntary action by sponsor
can be requested by FDA
likely need to report to FDA
device recall classes - Answer- class 1: use will cause serious adverse health
consequences
class 2: use may cause temporary adverse health consequence
class 3: use not moment to cause serious adverse health consequences
180 day PMA supplement - Answer- change affects safety and effectiveness
requires in-depth FDA review
may require advisory committee
Special PMA Supplement - Answer- CBE - no need to review before making the change
only changes that increase device safety
30 day notice for PMA - Answer- CBE-30
used for charges to manufacturing procedures that affect safety and effectiveness
annual/periodic report for PMA - Answer- used to report any change that doesn't require
a supplement
doesn't affect safety or effectiveness
requires minimal FDA review
changes can be made before submitting the report
must report annually
, PMA Amendment - Answer- revise existing info or provide additional info
hde - Answer- no comparable FDA approved therapy exists and can't bring it to market
affects not more than 8000 people
demonstrate safe but but effective. and probable benefits must outweigh the ridge
when to register and list - Answer- within 30 days of beginning an activity or distributing
a device
before importing products
after clearance/approval
panel track supplement - Answer- changes to indication requiring substantial clinical
data
PMA
real time supplement - Answer- PMA
minor change
agency has granted a meeting to review
manufacturing site change supplement - Answer- for making changes that affect safety
or effectiveness of the device to change to a different facility
must be reviewed before can happen
types of inspections - Answer- pre approval for a PMA
PMA post marketing: typically 8-12 months after PMA approval
for cause
surveillance inspection
medical device amendments 1976 - Answer- separated medical devices from the drug
regulations
expanded definition of a misbranded device
MDUFA
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