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RAC US Devices Exam Questions and Answers All Correct

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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: ...

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  • November 1, 2024
  • 5
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers

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  • RAC US Devices
  • RAC US Devices

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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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