RAC Medical Devices TEST STUDY GUIDE
2025/2026 ACCURATE QUESTIONS AND
VERIFIED CORRECT SOLUTIONS WITH
RATIONALES || 100% GUARANTEED PASS
<LATEST VERSION>
1. Device - ANSWER ✓ instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent or related article:
-recognized by NF-USP
-intended for use in diagnosis of disease or other condition, or in the cure,
mitigation, treatment or prevention of disease
-intended to affect the structure or function of the body
-not achieving any primary purpose through chemical action
-not dependent on metabolism for primary purpose
2. Exempt device - ANSWER ✓ Exempt from 510(k) if:
-Diagnostic device that was in distribution before 28MAY76, not a
transitional device
-is noninvasive
-does not introduce energy into subject
-not used for diagnosis without confirmation from another procedure
3. More than 800 generic class I devices and 60 class II devices (documented
in 21CFR 862-892)
-Does not require clinical trials
-Also may be exempt from GMPs (noted in regulation)
4. Devices used for collecting, processing, storing and administering blood
products - ANSWER ✓ Approved by CBER as devices (510(k) or PMA)
5. finished device - ANSWER ✓ any device or accessory to any device that is
suitable for use or capable of functioning, whether or not it is packaged,
labeled, or sterilized
,6. Software - ANSWER ✓ considered a device when used for a medical
purpose without being part of a device's hardware
7. Mobile medical app - ANSWER ✓ considered a device when it meets the
definition of a device
8. Accessory - ANSWER ✓ may be used with multiple parent devices or has
unique stand-alone functions
9. Class I device - ANSWER ✓ General controls to ensure safety &
effectiveness.
-Low-risk device requiring
-Usually exempt from 510k (93%) and QSR
-Examples include exam gloves, hospital beds, lab equipment, surgical
instruments, bandages
10.Class II device - ANSWER ✓ General and special controls to ensure safety
and effectiveness.
-Requires 510(k) unless exempted (8%); may require clinical trials.
-Examples include blood glucose test systems and infusion pumps, catheters,
blood pressure cuff, ELISAs
11.Class III device - ANSWER ✓ Requires general controls, special controls
and premarket approval (PMA);
-includes devices that are life-sustaining, life-supporting or pose significant
potential for risk to patient; PMAs almost always require clinical trials.
-Examples include heart valves, breast implants, orthopedic implants, tubal
occlusion devices
12.transitional devices - ANSWER ✓ Regulated as drugs before 1976 and are
now governed by a PMA
-Reclassification to II or I takes significant resources
13.A manufacturer sells 1,500 medical devices in the two months following
launch. A user, but not a patient, is seriously injured while using the medical
device. The investigation reveals the cause to be an error in a software
subroutine that has a one in 195,000 chance of happening. Management is
concerned about how the incident may result in serious problems in the
, marketplace. What recommendation is MOST appropriate for the regulatory
professional to make to management?
A. Complete a product recall for the 1,500 medical devices already sold.
B. Complete a corrective action following the manufacturer's procedures.
C. Discuss the incident with the authorities, explaining the small margin
of error.
D. Discuss the incident with the authorities and send an advisory letter to
each customer. - ANSWER ✓ D. Discuss the incident with the
authorities and send an advisory letter to each customer.
14.An adverse event has been reported in connection with a medical device.
When assessing the link between the device and the adverse event, which of
the following is the LEAST relevant?
A. Complaint trends from users
B. Cost of medical device replacement
C. Information concerning previous, similar events
D. Opinions from healthcare professionals - ANSWER ✓ B. Cost of
medical device replacement
15.During a routine inspection of the promotional materials of a medical
device, the regulatory professional notices a factual error. This error could
potentially lead to an incorrect usage of the device. A search of the
company's safety database finds multiple reported events due to the error,
none of which was serious. The IFU for the medical device contain the
correct information. According to GHTF guidelines, does this error need to
be reported?
A. Yes, the mistake in the promotional materials is misleading the users
of the medical device.
B. Yes, the misinformation could lead to death or serious injury to a
patient.
C. No, the IFU contain the correct information.
, D. No, there were no reports of any serious events due to the
misinformation. - ANSWER ✓ B. Yes, the misinformation could lead
to death or serious injury to a patient.
16.A medical device licensed in Canada led to the serious deterioration of a
patient's health in the US. As a result of the investigation, it was discovered
that the product specification for sterility for this particular lot was affected.
The event and the proposed corrective actions were reported to the FDA.
The US-based regulatory professional informs the Canadian-based
regulatory professional about this occurrence and indicates that the affected
lot was marketed only in the US. Which of the following recommendations
should the Canadian-based regulatory professional make to his/her
organization?
A. File the incident in the complaints database.
B. Report the incident to the company's president.
C. Report the incident to the HPFBI.
D. No action is required. - ANSWER ✓ C. Report the incident to the
HPFBI.
17.Record-keeping requirements for marketed products are intended to provide
assurance of which of the following?
A. Continued labeling claims
B. Field performance
C. Maintenance of product safety
D. Traceability in distribution - ANSWER ✓ D. Traceability in
distribution
18.Traditional 510(K) - ANSWER ✓ A premarket notification submitted to
FDA to demonstrate the medical device to be marketed is as safe and
effective or "substantially equivalent" to a legally marketed device.
2025/2026 ACCURATE QUESTIONS AND
VERIFIED CORRECT SOLUTIONS WITH
RATIONALES || 100% GUARANTEED PASS
<LATEST VERSION>
1. Device - ANSWER ✓ instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent or related article:
-recognized by NF-USP
-intended for use in diagnosis of disease or other condition, or in the cure,
mitigation, treatment or prevention of disease
-intended to affect the structure or function of the body
-not achieving any primary purpose through chemical action
-not dependent on metabolism for primary purpose
2. Exempt device - ANSWER ✓ Exempt from 510(k) if:
-Diagnostic device that was in distribution before 28MAY76, not a
transitional device
-is noninvasive
-does not introduce energy into subject
-not used for diagnosis without confirmation from another procedure
3. More than 800 generic class I devices and 60 class II devices (documented
in 21CFR 862-892)
-Does not require clinical trials
-Also may be exempt from GMPs (noted in regulation)
4. Devices used for collecting, processing, storing and administering blood
products - ANSWER ✓ Approved by CBER as devices (510(k) or PMA)
5. finished device - ANSWER ✓ any device or accessory to any device that is
suitable for use or capable of functioning, whether or not it is packaged,
labeled, or sterilized
,6. Software - ANSWER ✓ considered a device when used for a medical
purpose without being part of a device's hardware
7. Mobile medical app - ANSWER ✓ considered a device when it meets the
definition of a device
8. Accessory - ANSWER ✓ may be used with multiple parent devices or has
unique stand-alone functions
9. Class I device - ANSWER ✓ General controls to ensure safety &
effectiveness.
-Low-risk device requiring
-Usually exempt from 510k (93%) and QSR
-Examples include exam gloves, hospital beds, lab equipment, surgical
instruments, bandages
10.Class II device - ANSWER ✓ General and special controls to ensure safety
and effectiveness.
-Requires 510(k) unless exempted (8%); may require clinical trials.
-Examples include blood glucose test systems and infusion pumps, catheters,
blood pressure cuff, ELISAs
11.Class III device - ANSWER ✓ Requires general controls, special controls
and premarket approval (PMA);
-includes devices that are life-sustaining, life-supporting or pose significant
potential for risk to patient; PMAs almost always require clinical trials.
-Examples include heart valves, breast implants, orthopedic implants, tubal
occlusion devices
12.transitional devices - ANSWER ✓ Regulated as drugs before 1976 and are
now governed by a PMA
-Reclassification to II or I takes significant resources
13.A manufacturer sells 1,500 medical devices in the two months following
launch. A user, but not a patient, is seriously injured while using the medical
device. The investigation reveals the cause to be an error in a software
subroutine that has a one in 195,000 chance of happening. Management is
concerned about how the incident may result in serious problems in the
, marketplace. What recommendation is MOST appropriate for the regulatory
professional to make to management?
A. Complete a product recall for the 1,500 medical devices already sold.
B. Complete a corrective action following the manufacturer's procedures.
C. Discuss the incident with the authorities, explaining the small margin
of error.
D. Discuss the incident with the authorities and send an advisory letter to
each customer. - ANSWER ✓ D. Discuss the incident with the
authorities and send an advisory letter to each customer.
14.An adverse event has been reported in connection with a medical device.
When assessing the link between the device and the adverse event, which of
the following is the LEAST relevant?
A. Complaint trends from users
B. Cost of medical device replacement
C. Information concerning previous, similar events
D. Opinions from healthcare professionals - ANSWER ✓ B. Cost of
medical device replacement
15.During a routine inspection of the promotional materials of a medical
device, the regulatory professional notices a factual error. This error could
potentially lead to an incorrect usage of the device. A search of the
company's safety database finds multiple reported events due to the error,
none of which was serious. The IFU for the medical device contain the
correct information. According to GHTF guidelines, does this error need to
be reported?
A. Yes, the mistake in the promotional materials is misleading the users
of the medical device.
B. Yes, the misinformation could lead to death or serious injury to a
patient.
C. No, the IFU contain the correct information.
, D. No, there were no reports of any serious events due to the
misinformation. - ANSWER ✓ B. Yes, the misinformation could lead
to death or serious injury to a patient.
16.A medical device licensed in Canada led to the serious deterioration of a
patient's health in the US. As a result of the investigation, it was discovered
that the product specification for sterility for this particular lot was affected.
The event and the proposed corrective actions were reported to the FDA.
The US-based regulatory professional informs the Canadian-based
regulatory professional about this occurrence and indicates that the affected
lot was marketed only in the US. Which of the following recommendations
should the Canadian-based regulatory professional make to his/her
organization?
A. File the incident in the complaints database.
B. Report the incident to the company's president.
C. Report the incident to the HPFBI.
D. No action is required. - ANSWER ✓ C. Report the incident to the
HPFBI.
17.Record-keeping requirements for marketed products are intended to provide
assurance of which of the following?
A. Continued labeling claims
B. Field performance
C. Maintenance of product safety
D. Traceability in distribution - ANSWER ✓ D. Traceability in
distribution
18.Traditional 510(K) - ANSWER ✓ A premarket notification submitted to
FDA to demonstrate the medical device to be marketed is as safe and
effective or "substantially equivalent" to a legally marketed device.
