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
Under the FDA Quality System Regulation (21 CFR Part 820), what is required of suppliers providing critical components for dental implants?
Answer: Suppliers must be evaluated and selected based on their ability to meet specified requirements
21 CFR 820.50 requires manufacturers to establish supplier control procedures to ensure purchased products and services meet specified requirements.
Which of the following best describes a 'unique device identifier' (UDI) requirement for dental implants?
Answer: A standardized numeric or alphanumeric code that identifies the device and its production information
UDI regulations (21 CFR Part 830) require a standardized identifier on device labels to improve traceability throughout the supply chain and post-market surveillance.
A CIT discovers that a batch of implants was manufactured using a titanium alloy that deviates from the approved specification. What regulatory obligation is triggered?
Answer: Initiating a nonconformance report and CAPA under the QMS
Material deviations from specifications must be documented as nonconformances and addressed through CAPA to prevent recurrence and assess potential patient risk.
Which ADA standard provides specifications for endosseous implants in the United States?
Answer: ANSI/ADA Standard No. 131 (Osseointegrated Dental Implants)
ANSI/ADA Standard No. 131 covers requirements for osseointegrated dental implants including design, materials, and testing.
What is the primary distinction between 'sterile' and 'sterilized' labeling on dental implant packaging?
Answer: 'Sterile' indicates validated sterility assurance; 'sterilized' may only indicate a sterilization attempt without full validation
'Sterile' on labeling implies a validated sterility assurance level (SAL) of 10⁻⁶, while 'sterilized' may not guarantee the same validated standard.
Under HIPAA regulations, which implant-related patient data must be protected as Protected Health Information (PHI)?
Answer: Any individually identifiable health information including implant placement records
HIPAA protects all individually identifiable health information in any format, including implant placement dates, surgical notes, and patient-device records.
Which federal law regulates occupational exposure to radiation from cone beam CT (CBCT) equipment used in implant planning?
Answer: FDA Radiation Control provisions under 21 CFR Part 1020
21 CFR Part 1020 under FDA's radiation control program sets performance standards for diagnostic X-ray equipment including CBCT units.