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RAC DEVICES Questions and CORRECT Answers 2024/2025
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RAC DEVICES Questions and CORRECT Answers 2024/2025
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RAC DEVICESA 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 - ANSD 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. - ANSD. 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 - ANSDesign
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 - ANSThe 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 - ANSAll 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 - ANSB 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 - ANSC. 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 - ANSRe-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?
0 Contact the review division to determine the co,
1 Contact the review division to determine whether a 510(k) or PMA should be prepared,
2 Prepare a 510(k) premarket notification claiming,
3 Prepare a 510(k) premarket notification claiming - ANS1 Contact the review division to
determine whether a 510(k) or PMA should be prepared
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