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RAC US devices Exam (Version 2) (Questions & Answers with rationale) (Latest updated $10.39   Add to cart

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RAC US devices Exam (Version 2) (Questions & Answers with rationale) (Latest updated

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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...

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  • October 30, 2024
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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

21 CFR 820.30
doesn't apply to class 1

design input/output, design review, design validation/verification, design transfer, design
history file

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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