CIT Regulatory Compliance & Standards 3 — Questions and Answers
Question 1: When a dental implant is labeled 'sterile,' which sterilization validation standard most commonly applies?
- ISO 11135 (EO sterilization)
- ISO 11137 (radiation sterilization)
- ANSI/AAMI ST79 (steam sterilization)
- All of the above depending on the method used (Correct answer)
Correct 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.
Question 2: What is a Corrective and Preventive Action (CAPA) system primarily designed to address in a dental implant facility?
- Financial auditing procedures
- Nonconformances and potential quality problems to prevent recurrence (Correct answer)
- Employee scheduling and training records
- Marketing and sales compliance
Correct 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.
Question 3: Which regulation requires dental implant manufacturers to submit Medical Device Reports (MDRs) for serious adverse events?
- 21 CFR Part 803 (Correct answer)
- 21 CFR Part 820
- 21 CFR Part 801
- 21 CFR Part 807
Correct 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.
Question 4: A CIT notices implant packaging has been compromised before use. According to regulatory compliance, what is the correct action?
- Inspect the implant visually and proceed if it looks clean
- Use the implant immediately and document the packaging issue
- Discard the implant and report through the facility's nonconformance system (Correct answer)
- Re-sterilize the implant using the office autoclave
Correct 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.
Question 5: What does CE marking on a dental implant indicate in international trade contexts?
- The implant meets Canadian safety requirements
- The device conforms to European Union health, safety, and environmental protection standards (Correct answer)
- The implant is approved for use in China exclusively
- The device has received FDA clearance for the US market
Correct 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.
Question 6: Which document must accompany a dental implant at point of sale to ensure device traceability under US regulations?
- Certificate of Insurance
- Device labeling including lot/batch number and expiration date (Correct answer)
- Manufacturer's financial disclosure
- Surgeon's license copy
Correct 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.
Question 7: What is the significance of a 'predicate device' in the FDA 510(k) clearance pathway?
- It represents the newest technology on the market
- It is a legally marketed device to which a new device can be shown to be substantially equivalent (Correct answer)
- It is a device that has been recalled by the FDA
- It refers to the device most commonly used by dental specialists
Correct 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.
CIT Regulatory Compliance & Standards 3
When a dental implant is labeled 'sterile,' which sterilization validation standard most commonly applies?