RAC Regulatory Frameworks 3

Question 1

Under FDA's risk-based approach to device classification, a Class III device requires which type of premarket review?

Accepted Answer

Premarket Approval Application (PMA)

Answer

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?

Accepted Answer

ICH Q8 (Pharmaceutical Development) and ICH Q9 (Quality Risk Management)

Answer

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?

Accepted Answer

Class IIa, IIb, and III devices

Answer

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)?

Accepted Answer

Identify approved drug products and their therapeutic equivalence determinations

Answer

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?

Accepted Answer

The primary mode of action (PMOA) of the combination product

Answer

For combination products, FDA assigns jurisdiction to the center with regulatory authority over the component that provides the primary mode of action.

(RAC) Regulatory Affairs Certification Practice Test

(RAC) Regulatory Affairs Certification Practice Test

RAC Regulatory Frameworks 3