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
When a dental implant is labeled 'sterile,' which sterilization validation standard most commonly applies?
Answer: All of the above depending on the method used
The applicable sterilization validation standard depends on the method used — ISO 11135 for ethylene oxide, ISO 11137 for radiation, and ANSI/AAMI ST79 for steam.
What is a Corrective and Preventive Action (CAPA) system primarily designed to address in a dental implant facility?
Answer: Nonconformances and potential quality problems to prevent recurrence
CAPA systems identify, investigate, and eliminate the root cause of nonconformances and potential quality issues per 21 CFR 820.100.
Which regulation requires dental implant manufacturers to submit Medical Device Reports (MDRs) for serious adverse events?
Answer: 21 CFR Part 803
21 CFR Part 803 (Medical Device Reporting) mandates manufacturers to report device malfunctions and serious injuries or deaths to the FDA.
A CIT notices implant packaging has been compromised before use. According to regulatory compliance, what is the correct action?
Answer: Discard the implant and report through the facility's nonconformance system
Compromised sterile packaging invalidates the sterility guarantee; the implant must be discarded and the event documented as a nonconformance.
What does CE marking on a dental implant indicate in international trade contexts?
Answer: The device conforms to European Union health, safety, and environmental protection standards
CE marking indicates conformity with EU Medical Device Regulation (MDR 2017/745), allowing the product to be sold within the European Economic Area.
Which document must accompany a dental implant at point of sale to ensure device traceability under US regulations?
Answer: Device labeling including lot/batch number and expiration date
FDA regulations require labeling with traceability information such as lot number and expiration date to support recall effectiveness and post-market surveillance.
What is the significance of a 'predicate device' in the FDA 510(k) clearance pathway?
Answer: It is a legally marketed device to which a new device can be shown to be substantially equivalent
A 510(k) clearance requires demonstrating substantial equivalence to a predicate — a device already legally marketed in the US.