CIT Regulatory Compliance & Standards 2 — Questions and Answers
Question 1: Under FDA regulations, dental implants are classified as which device class?
- Class I (General Controls)
- Class II (Special Controls)
- Class III (Premarket Approval) (Correct answer)
- Class IV (Investigational)
Correct answer: Class III (Premarket Approval)
Dental implants are FDA Class III devices requiring Premarket Approval (PMA) due to their life-sustaining or implanted nature.
Question 2: Which ISO standard specifically governs dental implants and their components?
- ISO 9001
- ISO 13485
- ISO 14801 (Correct answer)
- ISO 10993
Correct answer: ISO 14801
ISO 14801 specifies the fatigue test method for endosseous dental implants under dynamic loading conditions.
Question 3: A dental implant manufacturer must submit which document to the FDA before marketing a novel implant system?
- 510(k) Premarket Notification
- Premarket Approval (PMA) Application (Correct answer)
- De Novo Request
- Investigational Device Exemption (IDE)
Correct answer: Premarket Approval (PMA) Application
Novel Class III dental implants with no predicate device require a PMA application demonstrating reasonable assurance of safety and effectiveness.
Question 4: What does the term 'biocompatibility' refer to in the context of ISO 10993?
- Mechanical strength of the implant
- Ability of a material to perform without eliciting a harmful response in a biological system (Correct answer)
- Sterilization efficacy of implant packaging
- Dimensional accuracy of the implant
Correct answer: Ability of a material to perform without eliciting a harmful response in a biological system
ISO 10993 defines biocompatibility as the ability of a medical device material to perform with an appropriate host response in a specific application.
Question 5: Which regulatory body enforces Good Manufacturing Practice (GMP) for dental implant manufacturers in the United States?
- American Dental Association (ADA)
- Food and Drug Administration (FDA) (Correct answer)
- Centers for Medicare & Medicaid Services (CMS)
- Occupational Safety and Health Administration (OSHA)
Correct answer: Food and Drug Administration (FDA)
The FDA enforces GMP requirements under 21 CFR Part 820 (Quality System Regulation) for medical device manufacturers, including dental implants.
Question 6: What is the primary purpose of a Design History File (DHF) in implant device regulation?
- To document post-market surveillance data
- To record all design and development activities for a device (Correct answer)
- To track sterilization cycle logs
- To maintain supplier qualification records
Correct answer: To record all design and development activities for a device
The DHF contains records demonstrating that the device design was developed in accordance with the approved design plan and FDA requirements under 21 CFR 820.30.
Question 7: Under OSHA's Bloodborne Pathogens Standard, which practice is required when handling used implant components?
- Double-gloving only
- Universal precautions with appropriate PPE (Correct answer)
- Simple hand washing before and after contact
- Using chemical disinfectants without PPE
Correct answer: Universal precautions with appropriate PPE
OSHA's Bloodborne Pathogens Standard (29 CFR 1910.1030) requires universal precautions treating all human blood and OPIM as infectious, necessitating appropriate PPE.
CIT Regulatory Compliance & Standards 2
Under FDA regulations, dental implants are classified as which device class?