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2024 RAC PRACTICE EXAM QUESTIONS WITH 100% CORRECT ANSWERS VERIFIED LATEST UPDATE 2024 GRADED A+
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2024 RAC PRACTICE EXAM QUESTIONS WITH 100% CORRECT ANSWERS VERIFIED LATEST UPDATE 2024 GRADED A+
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2024 RAC PRACTICE EXAM QUESTIONSWITH 100% CORRECT ANSWERS VERIFIED
LATEST UPDATE 2024 GRADED A+
A physician reports to a manufacturer that a patient was hospitalized with acute
sepsis after treatment with an approved device. This side effect is not listed in
the package insert. This event must be reported by the manufacturer to FDA no
later than:
• 5 calendar days.
• 15 calendar days.
• 30 calendar days.
• The next quarterly or annual report. - ✔✔C. 30 calendar days.
Serious injury must be reported within 30 days. 21 CFR 803.50(a).
Under the IDE regulation, all of the following must be reported to the sponsor
within five working days EXCEPT:
,• A deviation from the investigational plan.
• Withdrawal of IRB approval.
• An unanticipated adverse device effect.
• Use of a device without informed consent. - ✔✔C. An unanticipated
adverse device effect.
The investigator notifies the sponsor and IRB within 10 days of notification of any
unanticipated adverse effect. 21 CFR 812.150.
When design verification testing is being performed by a manufacturer, which
element is NOT included as a potential requirement under device design
verification section of the QSR?
• Identification of the design.
• Software validation.
,• Identification of test methods used.
• Name of individuals performing the testing. - ✔✔C. Identification of
test methods used.
Refer to 820.30(f)
Under the statutory violations, lack of an approved PMA for a PMA device that is
not exempt and is in commercial distribution is considered to be:
• Adulteration
• Improper use
• Misbranded
• Fraudulent - ✔✔A. Adulteration
PMA products introduced into commercial distribution without an approval
PMA are considered to be adulterated. FD&C Act 501(f).
, A manufacturer of the following must file an IDE before conducting a human
clinical study?
• A device in commercial distribution before 28 May 1976 when used or
investigated in accordance with its indications in labeling in effect at that
time.
• A device intended solely for veterinary use.
• A custom device being studied for safety and effectiveness.
• A device in commercial distribution before 28 May 1976 when used or
investigated in accordance with its indications in labeling in effect at that
time. And a device intended solely for veterinary use. - ✔✔C. A custom
device being studied for safety and effectiveness.
While a custom device may be studied in humans without an IDE, if its safety
and efficacy are being studied in support of commercial marketing, an IDE must
be filed (21 CFR 812.2(c)(7)
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