Regulatory Frameworks Flashcards
7 cards from real RAC 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 Frameworks flashcards as text
Under FDA's risk-based approach to device classification, a Class III device requires which type of premarket review?
Answer: Premarket Approval Application (PMA)
Class III devices, which support or sustain human life or present high risk, require a PMA demonstrating reasonable assurance of safety and effectiveness.
The ICH Q10 pharmaceutical quality system model is designed to be used in combination with which other ICH guideline?
Answer: ICH Q8 (Pharmaceutical Development) and ICH Q9 (Quality Risk Management)
ICH Q10 is intended to complement ICH Q8 on pharmaceutical development and ICH Q9 on quality risk management, forming an integrated quality triad.
Under the EU MDR (Regulation 2017/745), which class of medical devices requires involvement of a Notified Body for conformity assessment?
Answer: Class IIa, IIb, and III devices
Under EU MDR, Class IIa, IIb, and III devices all require a Notified Body for conformity assessment; most Class I devices use manufacturer self-declaration.
What is the primary purpose of FDA's Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations)?
Answer: Identify approved drug products and their therapeutic equivalence determinations
The Orange Book lists FDA-approved drug products and evaluates their therapeutic equivalence to assist state pharmacy boards and others with drug substitution decisions.
A regulatory affairs professional is reviewing a combination product. Which FDA Center has jurisdiction is primarily determined by?
Answer: The primary mode of action (PMOA) of the combination product
For combination products, FDA assigns jurisdiction to the center with regulatory authority over the component that provides the primary mode of action.
Under 21 CFR Part 11, what is required for electronic signatures to be considered legally binding equivalents to handwritten signatures?
Answer: Each electronic signature must be unique to one individual and not reused or reassigned
21 CFR Part 11 requires electronic signatures to be unique to each individual and states they cannot be reused, reassigned, or transferred to another person.
Which international regulatory body issues the International Nonproprietary Name (INN) for pharmaceutical substances?
Answer: World Health Organization (WHO)
The WHO Expert Group on INN is responsible for selecting, reviewing, and publishing International Nonproprietary Names for pharmaceutical substances globally.