RAC Regulatory Frameworks 3 — Questions and Answers
Question 1: Under FDA's risk-based approach to device classification, a Class III device requires which type of premarket review?
- 510(k) premarket notification
- De Novo request
- Premarket Approval Application (PMA) (Correct answer)
- Humanitarian Device Exemption (HDE)
Correct 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.
Question 2: The ICH Q10 pharmaceutical quality system model is designed to be used in combination with which other ICH guideline?
- ICH Q8 (Pharmaceutical Development) and ICH Q9 (Quality Risk Management) (Correct answer)
- ICH E8 (General Considerations for Clinical Studies) only
- ICH S1A (Carcinogenicity Testing) guidelines
- ICH M4 (Common Technical Document) format
Correct 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.
Question 3: Under the EU MDR (Regulation 2017/745), which class of medical devices requires involvement of a Notified Body for conformity assessment?
- Class I devices only when sterile or measuring
- Class IIa, IIb, and III devices (Correct answer)
- Class III devices only
- All classes including Class I non-sterile, non-measuring devices
Correct 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.
Question 4: What is the primary purpose of FDA's Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations)?
- List all drugs with pending NDA applications
- Identify approved drug products and their therapeutic equivalence determinations (Correct answer)
- Provide clinical trial data for marketed drugs
- Catalog drug adverse events reported post-approval
Correct 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.
Question 5: A regulatory affairs professional is reviewing a combination product. Which FDA Center has jurisdiction is primarily determined by?
- The country of the product's manufacture
- The primary mode of action (PMOA) of the combination product (Correct answer)
- The therapeutic indication claimed in the application
- Which center the sponsor prefers to work with
Correct 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.
Question 6: Under 21 CFR Part 11, what is required for electronic signatures to be considered legally binding equivalents to handwritten signatures?
- Electronic signatures only need to include the signer's name
- Each electronic signature must be unique to one individual and not reused or reassigned (Correct answer)
- Signatures must be witnessed by a second individual in real time
- Only wet ink signatures are legally binding under FDA regulations
Correct 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.
Question 7: Which international regulatory body issues the International Nonproprietary Name (INN) for pharmaceutical substances?
- International Organization for Standardization (ISO)
- World Health Organization (WHO) (Correct answer)
- ICH Steering Committee
- United States Adopted Names (USAN) Council
Correct 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.
RAC Regulatory Frameworks 3
Under FDA's risk-based approach to device classification, a Class III device requires which type of premarket review?