RAC US devices Exam (Version 2) (Questions & Answers with rationale) (Latest updated
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RAC US devices
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RAC US Devices
RAC US devices Exam (Version 2) (Questions & Answers with rationale) (Latest updated
do IDE devices require cgmp compliance? - Answer -no cgmp compliance required for IDE devices
abbreviated IDE - Answer -doesn't require FDA approval
non significant risk devices or studies only
supplement...
RAC US devices Exam (Version 2)
(Questions & Answers with rationale) (Latest
updated
do IDE devices require cgmp compliance? - Answer -no cgmp compliance required for
IDE devices
abbreviated IDE - Answer -doesn't require FDA approval
non significant risk devices or studies only
supplement IDE submissions required for charges to: - Answer -investigational plan
informed consent
other substantive info
when is a special 510k used? - Answer -when a sponsor wants to modify their own 510k
device
does not include changes to:
intended use, instructions, or technology
special 510k reg - Answer -21 CFR 807.87
design controls - Answer -manufacturers must establish and maintain procedures to
control the design of the device to ensure designs reqs are met
MDR reporting timeline for cleared/approved devices - Answer -serious or likely to be
serious: 30 days
requires immediate action: 5 days
MDR reporting timeline for IDE devices - Answer -unanticipated adverse effect: 10
business days
what is a device recall? - Answer -generally a voluntary action by sponsor
can be requested by FDA
likely need to report to FDA
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