Missouri Medical Device Compliance
Inspector Exam Practice Questions And
Correct Answers (Verified Answers) Plus
Rationale 2026 Q&A| Instant Download
Pdf
1. A medical device compliance inspector is evaluating a Class II infusion
pump manufactured for hospital use. The inspector discovers that the
device labeling lacks a clear statement of intended use, but the
technical manual includes partial usage instructions. Which regulatory
requirement is most directly violated?
A. Device labeling must include FDA clearance number only
B. Labeling must fully describe intended use and indications for use
C. Technical manuals are sufficient in place of external labeling
D. Only sterilization instructions are required on labeling
B. Labeling must fully describe intended use and indications for use
The Federal requirements for medical device labeling mandate that devices
,clearly state their intended use and indications for use on the labeling
itself, not solely in internal manuals. Missing this information may lead to
misbranding and non-compliance regardless of internal documentation
completeness.
2. During an inspection, a Missouri compliance officer finds that a
manufacturer of Class III implantable devices has not implemented a
Quality System Regulation (QSR) complaint handling procedure. Which
section of the QSR is most relevant?
A. 21 CFR 820.198 Complaint Files
B. 21 CFR 820.30 Design Controls
C. 21 CFR 820.50 Purchasing Controls
D. 21 CFR 820.100 Corrective and Preventive Action
A. 21 CFR 820.198 Complaint Files
Complaint handling systems are explicitly required under 21 CFR 820.198,
which mandates procedures for receiving, reviewing, and evaluating
complaints related to medical devices. Failure to maintain this system
represents a direct regulatory violation.
3. A device inspector discovers that calibration records for diagnostic
equipment used in manufacturing are missing for the past six months.
Which compliance principle is primarily affected?
,A. Marketing authorization compliance
B. Equipment maintenance and calibration control
C. Export documentation requirements
D. Device classification rules
B. Equipment maintenance and calibration control
Medical device manufacturers must maintain calibration records to ensure
equipment accuracy and reliability. Missing calibration documentation
undermines production consistency and violates quality system
requirements.
4. A facility producing Class I medical devices without sterility claims is
not registering with regulatory authorities. What is the most accurate
regulatory expectation?
A. Class I devices are always exempt from registration
B. Registration is required regardless of device classification
C. Only foreign manufacturers must register
D. Registration is optional for non-sterile devices
B. Registration is required regardless of device classification
Even Class I manufacturers must register their establishment unless
specifically exempted. Registration ensures regulatory oversight and
traceability within the medical device supply chain.
, 5. An inspector finds that a manufacturer is using expired validation
protocols for sterilization of reusable surgical instruments. What is the
primary compliance concern?
A. Financial reporting error
B. Validation process is not current or scientifically justified
C. Device classification mismatch
D. Packaging design failure
B. Validation process is not current or scientifically justified
Sterilization validation must be current and scientifically validated to
ensure effectiveness. Using expired or outdated validation protocols
compromises patient safety and violates regulatory standards.
6. A medical device company fails to document corrective actions after
identifying recurring product defects. Which regulatory system is
being violated?
A. Design History File (DHF) requirements
B. Corrective and Preventive Action (CAPA) system
C. Device labeling system
D. Clinical evaluation system
B. Corrective and Preventive Action (CAPA) system
The CAPA system requires identification, investigation, and documentation
of corrective actions to prevent recurrence of quality issues. Failure to
document actions indicates non-compliance.
Inspector Exam Practice Questions And
Correct Answers (Verified Answers) Plus
Rationale 2026 Q&A| Instant Download
1. A medical device compliance inspector is evaluating a Class II infusion
pump manufactured for hospital use. The inspector discovers that the
device labeling lacks a clear statement of intended use, but the
technical manual includes partial usage instructions. Which regulatory
requirement is most directly violated?
A. Device labeling must include FDA clearance number only
B. Labeling must fully describe intended use and indications for use
C. Technical manuals are sufficient in place of external labeling
D. Only sterilization instructions are required on labeling
B. Labeling must fully describe intended use and indications for use
The Federal requirements for medical device labeling mandate that devices
,clearly state their intended use and indications for use on the labeling
itself, not solely in internal manuals. Missing this information may lead to
misbranding and non-compliance regardless of internal documentation
completeness.
2. During an inspection, a Missouri compliance officer finds that a
manufacturer of Class III implantable devices has not implemented a
Quality System Regulation (QSR) complaint handling procedure. Which
section of the QSR is most relevant?
A. 21 CFR 820.198 Complaint Files
B. 21 CFR 820.30 Design Controls
C. 21 CFR 820.50 Purchasing Controls
D. 21 CFR 820.100 Corrective and Preventive Action
A. 21 CFR 820.198 Complaint Files
Complaint handling systems are explicitly required under 21 CFR 820.198,
which mandates procedures for receiving, reviewing, and evaluating
complaints related to medical devices. Failure to maintain this system
represents a direct regulatory violation.
3. A device inspector discovers that calibration records for diagnostic
equipment used in manufacturing are missing for the past six months.
Which compliance principle is primarily affected?
,A. Marketing authorization compliance
B. Equipment maintenance and calibration control
C. Export documentation requirements
D. Device classification rules
B. Equipment maintenance and calibration control
Medical device manufacturers must maintain calibration records to ensure
equipment accuracy and reliability. Missing calibration documentation
undermines production consistency and violates quality system
requirements.
4. A facility producing Class I medical devices without sterility claims is
not registering with regulatory authorities. What is the most accurate
regulatory expectation?
A. Class I devices are always exempt from registration
B. Registration is required regardless of device classification
C. Only foreign manufacturers must register
D. Registration is optional for non-sterile devices
B. Registration is required regardless of device classification
Even Class I manufacturers must register their establishment unless
specifically exempted. Registration ensures regulatory oversight and
traceability within the medical device supply chain.
, 5. An inspector finds that a manufacturer is using expired validation
protocols for sterilization of reusable surgical instruments. What is the
primary compliance concern?
A. Financial reporting error
B. Validation process is not current or scientifically justified
C. Device classification mismatch
D. Packaging design failure
B. Validation process is not current or scientifically justified
Sterilization validation must be current and scientifically validated to
ensure effectiveness. Using expired or outdated validation protocols
compromises patient safety and violates regulatory standards.
6. A medical device company fails to document corrective actions after
identifying recurring product defects. Which regulatory system is
being violated?
A. Design History File (DHF) requirements
B. Corrective and Preventive Action (CAPA) system
C. Device labeling system
D. Clinical evaluation system
B. Corrective and Preventive Action (CAPA) system
The CAPA system requires identification, investigation, and documentation
of corrective actions to prevent recurrence of quality issues. Failure to
document actions indicates non-compliance.
