Regulatory Compliance & Standards Flashcards
7 cards from real CIT practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Regulatory Compliance & Standards flashcards as text
In a dental implant recall scenario, which regulatory classification indicates the most serious risk to health?
Answer: Class I Recall
FDA Class I recalls involve situations where use of the device will cause serious adverse health consequences or death — the highest severity level.
What is the shelf-life requirement basis for sterile dental implant packaging under regulatory standards?
Answer: Real-time or accelerated aging studies validating sterility and package integrity over the claimed period
Shelf-life must be supported by real-time or accelerated aging studies per ASTM F1980 and ISO 11607 demonstrating maintained sterility and package integrity.
Which document defines the acceptance criteria for incoming implant components in a compliant quality management system?
Answer: Incoming inspection procedure with defined acceptance criteria
A documented incoming inspection procedure with defined acceptance criteria is required under 21 CFR 820.80 to verify components meet specifications before use.
A CIT is asked to validate a new torque wrench used during implant placement. Which step is essential per regulatory quality standards?
Answer: Perform calibration and document results against a traceable standard before placing it in service
21 CFR 820.72 requires equipment used in production and quality testing to be calibrated against nationally or internationally recognized standards, with documented results.
Which post-market surveillance activity is specifically required for Class III dental implant manufacturers?
Answer: Post-Approval Studies (PAS) as conditions of PMA approval
FDA may require Post-Approval Studies as a condition of PMA approval to monitor long-term safety and effectiveness of Class III devices in the real-world population.
What does 'intended use' on an FDA-cleared dental implant label legally define?
Answer: The clinical application for which the device is legally cleared and may be promoted
Intended use defines the specific clinical application for which the device received FDA clearance; promoting or using a device outside this use constitutes off-label use.
When must a dental implant facility conduct an internal quality audit under ISO 13485:2016?
Answer: At planned intervals to determine whether the QMS conforms to requirements and is effectively implemented
ISO 13485:2016 Clause 8.2.4 requires internal audits at planned intervals to assess QMS conformance and effectiveness, not just in response to problems.