DEVICE RAC PRACTICE EXAMINATION 2026 QUESTIONS WITH ANSWERS GRADED A+

DEVICE RAC PRACTICE EXAMINATION
2026 QUESTIONS WITH ANSWERS
GRADED A+

◍A
U. S. manufacturer becomes aware that a Class II device malfunctioned, and
if it recurred, it could lead to a serious injury. No injury occurred this
time.What action must the manufacturer take?
A. Submit a 5-day MDR
B. Submit a 30-day MDR
C. No MDR is required
D. Report only if a recall is issued.
Answer: B. Submit a 30-day MDR
◍ During an FDA inspection, the investigator issues an FDA Form 483.Which
of the following best describes the regulatory significance of this form?
A. It is a final regulatory action from FDA
B. It indicates criminal penalties are being pursued
C. It lists observations of potential noncompliance
D. It requires immediate product recall.
Answer: C. It lists observations of potential noncompliance
◍ A manufacturer of a Class IIb electrically powered, sterile infusion pump
wishes to CE mark the device under EU MD
R. The manufacturer has an ISO 13485-certified QM
S. Which conformity assessment route(s) are most appropriate?
A. Annex VII - Self-certification
B. Annex XI - Part A (Type Exam only)
C. Annex IX (Full QMS audit with product assessment) or Annex X + XI
D. Annex VIII - Classification rules only.

, Answer: C. Annex IX (Full QMS audit with product assessment) or Annex
X + XI
◍ Which of the following statements about the FDA Pre-Submission (Q-Sub)
program is TRUE?
A. Feedback from the FDA is binding
B. A Q-Sub is required before a 510(k)
C. It allows applicants to receive nonbinding feedback before submitting
applications
D. Only PMA applicants may use the Q-Sub process.
Answer: C. It allows applicants to receive nonbinding feedback before
submitting applications
◍ A humanitarian device exemption (HDE) differs from a traditional PMA in
that:
A. It does not require compliance with QS
R. B. Non-clinical data are not required.
C. Effectiveness data are not required.
D. Device characteristics are not required..
Answer: C. Effectiveness data are not required.
◍ Under EU MDR, the label of a sterile Class IIb device must include all of
the following EXCEPT:
A. UDI-DI and UDI-PI
B. Manufacturing site address
C. Sterilization method
D. Storage conditions (if applicable).
Answer: D. Storage conditions (if applicable)
◍ Which of the following is an example of an FDA special control for a Class
II device?
A. Device labeling must include warnings and contraindications
B. Device must undergo panel review
C. Clinical investigation must be conducted premarket
D. The device is exempt from GMP/QSR.

, Answer: A. Device labeling must include warnings and contraindications
◍ FDA currently requires that all device registration and listing information
(Annual, Initial or Updates) be submitted using:A) FDAs Unified
Registration and Listing SystemB) FDA Forms 2891 and 2892C) FDA
Forms 2656 and 2657D) FDA Form 3356.
Answer: A) 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/DeviceRegulationandGuidance/HowtoMarketY
◍ Inspections of device components received from a supplier may frequently
reveal product quality deficiencies. To avoid these instances, the supplier
should first have:
A. Expert GMP knowledge
B. Clear and precise specifications from the manufacturer
C. Detailed knowledge of the manufacturer's operations
D. An internal audit program.
Answer: B. Clear and precise specifications from the manufacturerAn
agreement outlining the manufacturer's specifications would minimize
quality deficiencies. 21 CFR 820.81(b).
◍ Under EU MDR, which class of device typically requires clinical
investigation unless sufficient clinical evidence already exists?
A. Class I
B. Class IIa

, C. Class IIb
D. Class III.
Answer: D. Class III
◍ If your firm commercially distributes a Class III device subject to PMA
without an approved PMA, what is the statutory violation?A)
AdulterationB) Improper UseC) MisbrandingD) Idiocy.
Answer: A) Adulteration
◍ Which of the following is the primary purpose of the Design History File
(DHF) under 21 CFR 820.30?
A. To record postmarket complaints
B. To prove each device was manufactured correctly
C. To show the device was developed in accordance with design controls
D. To describe all labeling components.
Answer: C. To show the device was developed in accordance with design
controls
◍ A manufacturer of a Class III implantable cardiac device wishes to update
the device's indication to include use in a younger age group, supported by a
new clinical trial.Which PMA supplement is required?
A. Real-Time Supplement
B. 180-Day Supplement
C. Panel-Track Supplement
D. Special Supplement.
Answer: C. Panel-Track Supplement
◍ A Class III implantable device is being placed on the market in 15 EU
countries. The IFU includes safety information and device performance
data.Which of the following best describes the labeling requirements under
EU MDR?
A. Labeling must be provided only in English for EU-wide distribution
B. The IFU must be translated into all official EU languages regardless of
target market
C. The IFU must be provided in the language(s) accepted by each member