RAC-DRUGS NEWEST EXAM TEST BANK 500
QUESTIONS WITH VERIFIED ANSWERS |GRADED
A+//100% CORRECT| LATEST 2026/27
B. Device Y is approved for marketing in the US
Class II devices are cleared for marketing in the US by the
FDA, not approved. Regulatory Reference: 21 CFR 807.97.
Company X is developing marketing materials for a Class II
medical device known as "Y". In one marketing piece, the
company talks about the clinical data supporting the
marketing of the device. Which of the following statements is
illegal and should NOT be included int eh marketing
materials?
A. Company X has conducted clinical studies to demonstrate
safety and effectiveness of device Y
B. Device Y is approved for marketing in the US
C. Warning: Device Y i not compatible with MRI equipment
D. Caution: Device Y, when improperly deployed, can cause
bleeding
B. Annual audits of operations.
Page 1 of 574
,FDA recommends periodic audits and does not specify a time.
Regulatory Reference: 21 CFR 820.3(22)
The Quality System Regulation calls for the manufacturer of
finished devices to carry out all of the following EXCEPT:
A. Quality audits conducted by individuals who do not have
direct responsibility for the operation being audited.
B. Annual audits of operations
C. Documetn the dates and results of quality audits and re-
audits
D. Have findings reviewed by management responsible for
the matters audited
D. Quality Manual (QM)
DHR is required per 21 CFR 820.184. DMR is required per
21 CFR 820.181. DHF is required per 21 CFR 820.30. Quality
Manual is a requirement of ISO13485:2003. It is not required
by QSR, although such a manual would be helpful in
explaining the nature and extent of the QMS to an FDA
investigator during an inspection. Regulatory Reference: 21
CFR Part 820 and ISO 13485.
The following are required per 21 CFR Part 820 Quality
System Regulation (QSR) EXCEPT:
Page 2 of 574
,A. Device History Record (DHR)
B. Device Master Record (DMR)
C. Design History File (DHF)
D. Quality Manual (QM)
) FDAs Unified Registration and Listing System (FURLS)
According to the FDA website, the Food and Drug
Administration Amendments Act (FDAAA) of 2007 requires
that all registration and listing information (Annual, Initial or
Updates) be submitted electronically unless FDA grants a
waiver. Furthermore, registration and listing information need
to be submitted by using FDA's Unified Registration and
Listing System (FURLS)/ Device Registration and Listing
Module (DRLM). This question tests whether the examinee's
knowledge on medical device establishment registration and
listing is current. Only Choice ID #1 is correct. The other
answers are distracters. Regulatory Reference: FDA Website:
How to register and list medical device
(http:/www.fda.gov/MedicalDevices/DeviceRegulationandGu
idance/HowtoMarketYourDevice/RegistrationandListing/ucm
053185.htm).
FDA currently requires that all medical device registration
and listing information (Annual, Initial or Updates) be
submitted using:
A) FDAs Unified Registration and Listing System
Page 3 of 574
, B) FDA Forms 2891 and 2892
C) FDA Forms 2656 and 2657
D) FDA Form 3356
(A) The investigational product must be manufactured in full
compliance with CGMP.
Devices under approved IDEs are exempt from CGMP
regulations except for design control requirements;
investigational new drugs must be compliant with CGMP for
finished pharmaceuticals. Regulatory Reference: 21 CFR 211.
Which of the following states is NOT true with respect to both
Investigational New Drug (IND) Applications and
Investigational Device Exemptions (IDEs) for significant- risk
products?
A. The investigational product must be manufactured in full
compliance with CGMP
B. Clinical studies must be reviewed and approved by an
Institutional Review Board
C. The IND or IDE goes into effect 30 days after FDA
receives the application, unless FDA notifies the sponsor
otherwise.
Page 4 of 574
QUESTIONS WITH VERIFIED ANSWERS |GRADED
A+//100% CORRECT| LATEST 2026/27
B. Device Y is approved for marketing in the US
Class II devices are cleared for marketing in the US by the
FDA, not approved. Regulatory Reference: 21 CFR 807.97.
Company X is developing marketing materials for a Class II
medical device known as "Y". In one marketing piece, the
company talks about the clinical data supporting the
marketing of the device. Which of the following statements is
illegal and should NOT be included int eh marketing
materials?
A. Company X has conducted clinical studies to demonstrate
safety and effectiveness of device Y
B. Device Y is approved for marketing in the US
C. Warning: Device Y i not compatible with MRI equipment
D. Caution: Device Y, when improperly deployed, can cause
bleeding
B. Annual audits of operations.
Page 1 of 574
,FDA recommends periodic audits and does not specify a time.
Regulatory Reference: 21 CFR 820.3(22)
The Quality System Regulation calls for the manufacturer of
finished devices to carry out all of the following EXCEPT:
A. Quality audits conducted by individuals who do not have
direct responsibility for the operation being audited.
B. Annual audits of operations
C. Documetn the dates and results of quality audits and re-
audits
D. Have findings reviewed by management responsible for
the matters audited
D. Quality Manual (QM)
DHR is required per 21 CFR 820.184. DMR is required per
21 CFR 820.181. DHF is required per 21 CFR 820.30. Quality
Manual is a requirement of ISO13485:2003. It is not required
by QSR, although such a manual would be helpful in
explaining the nature and extent of the QMS to an FDA
investigator during an inspection. Regulatory Reference: 21
CFR Part 820 and ISO 13485.
The following are required per 21 CFR Part 820 Quality
System Regulation (QSR) EXCEPT:
Page 2 of 574
,A. Device History Record (DHR)
B. Device Master Record (DMR)
C. Design History File (DHF)
D. Quality Manual (QM)
) FDAs Unified Registration and Listing System (FURLS)
According to the FDA website, the Food and Drug
Administration Amendments Act (FDAAA) of 2007 requires
that all registration and listing information (Annual, Initial or
Updates) be submitted electronically unless FDA grants a
waiver. Furthermore, registration and listing information need
to be submitted by using FDA's Unified Registration and
Listing System (FURLS)/ Device Registration and Listing
Module (DRLM). This question tests whether the examinee's
knowledge on medical device establishment registration and
listing is current. Only Choice ID #1 is correct. The other
answers are distracters. Regulatory Reference: FDA Website:
How to register and list medical device
(http:/www.fda.gov/MedicalDevices/DeviceRegulationandGu
idance/HowtoMarketYourDevice/RegistrationandListing/ucm
053185.htm).
FDA currently requires that all medical device registration
and listing information (Annual, Initial or Updates) be
submitted using:
A) FDAs Unified Registration and Listing System
Page 3 of 574
, B) FDA Forms 2891 and 2892
C) FDA Forms 2656 and 2657
D) FDA Form 3356
(A) The investigational product must be manufactured in full
compliance with CGMP.
Devices under approved IDEs are exempt from CGMP
regulations except for design control requirements;
investigational new drugs must be compliant with CGMP for
finished pharmaceuticals. Regulatory Reference: 21 CFR 211.
Which of the following states is NOT true with respect to both
Investigational New Drug (IND) Applications and
Investigational Device Exemptions (IDEs) for significant- risk
products?
A. The investigational product must be manufactured in full
compliance with CGMP
B. Clinical studies must be reviewed and approved by an
Institutional Review Board
C. The IND or IDE goes into effect 30 days after FDA
receives the application, unless FDA notifies the sponsor
otherwise.
Page 4 of 574
