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RAC DEVICES exam questions and answers 2025.
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RAC DEVICES exam questions and answers 2025.
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RAC DEVICES exam questions andanswers 2025
A company is performing routine site monitoring of its pivotal
clinical study for a blood sugar meter and finds one site has not
consented one-third of its subjects properly . What is the FIRST
thing the company needs to do?
A.Stop the entire study
B. Inform FDA and ask for guidance
C. Re-train the study staff, including the principle investigator
D. Re-consent all improperly consented subjects - answer D Re-
consent all improperly consented subjects
You are tasked with helping develop a regulatory intelligence
procedure for continuously collecting and analyzing regulatory
information pertaining to chromosome enumeration probes (CEPs),
a type of in vitro diagnostic (IVD) device. Which of the following
inputs should be considered when creating this procedure?
A. Sources of content (for example - blogs and white papers)
B. Identification of applicable government publications
C. Databases containing international standards and,
D. All options listed above should be considered. - answer D. All
options listed above should be considered.
Ensuring a medical device meets defined user needs and intended
use is accomplished through which type of validation?
0 Design, 1 Device, 2 Process, 3 Product - answer Design
,According to FDA, "remanufacturing" is the processing,
conditioning, renovating, repackaging, restoring, or any other act
done to a finished device that significantly changes which of the
following?
0 The performance/safety specification, or intended use of the
finished device,
1 The intended use or fundamental technology of the device,
2 The performance safety specification or operating,
3 The labeling and or packaging of the finished device - answer The
performance/safety specification, or intended use of the finished
device.
Cybersecurity is a responsibility of which of the following:
0 Device manufacturers and healthcare providers.,
1 Device manufacturers, healthcare providers, and ,
2 Regulators and vulnerability finders.,
3 All stakeholders - answer All Stakeholders
Which of the following represent cybersecurity information needed
for a 510(k) submission?
A. Objective evidence of manufacturer participation,
B. A list and justification for all cybersecurity c,
C. Device instructions for use and product specific,
B and C - answer B and C
Your company manufactures a patient scale that sometimes fails
testing during a certain stage of production. When this happens, the
product is inspected, repaired, and retested by a technician in the
, servicing department, and then returned to production for further
manufacturing. There exists only a small number of causes for
failure at this stage, and the repair solutions are simple and fast. In
order to help ensure compliance of this activity with ISO 13485,
which of the following MUST bein place?
A. Training of the servicing technician on all manufacturing,
B. Annual internal audit of this activity to ensure,
C. Documented procedures that describe the inspection, repair and
retesting activities.
A and B - answer C. Documented Procedures that describe the
inspection, repair, and retesting activities.
Prior to initiating a clinical trial, the company discovers that the
non-clinical study results were incorrectly documented. Which of the
following is the MOST appropriate course of action for the company?
0 Notify the IRB ethics committee and obtain re-approval,
1 Proceed with the clinical trial, but initiate p,
2 Re-evaluate the nonclinical data before proceeding with the
clinical trial,
3 Revalidate the protocol and repeat the nonclinical studies -
answer Re-evaluate the nonclinical data before proceeding with
the clinical trial.
A company wishes to expand existing labeling for a medical device
to include a new indication for use. What action should the
regulatory professional take FIRST?
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