CRAP Product Development & Compliance 2 — Questions and Answers
Question 1: During the Design Control process under 21 CFR Part 820, which document formally captures the intended use and user needs before design specifications are written?
- Design History File
- Design Input requirements (Correct answer)
- Device Master Record
- Design Validation protocol
Correct answer: Design Input requirements
Design Input requirements translate user needs and intended use into specific technical requirements before the design process begins.
Question 2: A sponsor conducting a first-in-human clinical trial for a medical device in the US must submit which document to FDA before proceeding?
- 510(k) premarket notification
- Investigational Device Exemption (IDE) (Correct answer)
- Premarket Approval Application (PMA)
- De Novo request
Correct answer: Investigational Device Exemption (IDE)
An IDE allows a medical device to be used in a clinical study to collect safety and effectiveness data without requiring full premarket approval.
Question 3: Under ICH Q8(R2), which development approach encourages defining a Design Space based on the relationship between process parameters and product quality attributes?
- Traditional development
- Quality by Design (QbD) (Correct answer)
- Quality by Testing (QbT)
- Risk-Proportionate Assessment
Correct answer: Quality by Design (QbD)
Quality by Design systematically designs pharmaceutical development to meet predefined objectives, including defining a Design Space that assures quality.
Question 4: Which risk management standard is most commonly applied during medical device product development to identify and control device-related hazards?
- ISO 14971 (Correct answer)
- ISO 13485
- IEC 62304
- ISO 9001
Correct answer: ISO 14971
ISO 14971 provides a framework for manufacturers to identify hazards, estimate risks, evaluate risks, control risks, and monitor the effectiveness of controls.
Question 5: A pharmaceutical company discovers a Critical Quality Attribute (CQA) is impacted by raw material variability. Per ICH Q9, what is the most appropriate next action?
- Immediately halt manufacturing
- Perform a formal risk assessment to determine control strategy adjustments (Correct answer)
- File a Prior Approval Supplement with FDA
- Revalidate all manufacturing equipment
Correct answer: Perform a formal risk assessment to determine control strategy adjustments
ICH Q9 directs manufacturers to conduct formal risk assessments when quality risks are identified, then adjust the control strategy proportionally to the risk level.
Question 6: In the context of combination products in the US, what determines the regulatory pathway (drug, device, or biologic) for a combination product?
- The component with the highest market value
- The primary mode of action (PMOA) (Correct answer)
- The manufacturing site location
- The route of administration
Correct answer: The primary mode of action (PMOA)
FDA assigns a combination product to an agency center based on the primary mode of action of the combination product as a whole.
Question 7: Which phase of the Stage-Gate development process is specifically focused on verifying that manufacturing processes can consistently produce product meeting specifications?
- Concept phase
- Feasibility phase
- Process validation (Correct answer)
- Post-market surveillance
Correct answer: Process validation
Process validation provides documented evidence that a manufacturing process consistently produces a product meeting its predetermined specifications and quality attributes.
CRAP Product Development & Compliance 2
During the Design Control process under 21 CFR Part 820, which document formally captures the intended use and user needs before design specifications are written?