MR Regulatory Framework and Compliance 2 — Questions and Answers
Question 1: Under 21 CFR Part 820, what is the primary purpose of a Design History File (DHF)?
- To document the history of the design of a finished device (Correct answer)
- To record customer complaints about design defects
- To track engineering change orders after product launch
- To store validation protocols for manufacturing equipment
Correct answer: To document the history of the design of a finished device
The DHF contains records demonstrating that the design was developed in accordance with the approved design plan and FDA requirements.
Question 2: A Management Representative receives an FDA Form 483 observation. What is the correct immediate action?
- File the observation and wait for the final warning letter
- Prepare a written response addressing each observation within 15 business days
- Halt all manufacturing operations until the observation is resolved
- Submit a corrective action plan within 30 days addressing each observation (Correct answer)
Correct answer: Submit a corrective action plan within 30 days addressing each observation
FDA expects a written response to 483 observations within 15 working days, but a comprehensive CAPA plan is the substantive requirement to prevent escalation.
Question 3: Which regulation governs Good Manufacturing Practice (GMP) for finished pharmaceuticals in the United States?
- 21 CFR Part 11
- 21 CFR Part 210 and 211 (Correct answer)
- 21 CFR Part 820
- 21 CFR Part 600
Correct answer: 21 CFR Part 210 and 211
21 CFR Parts 210 and 211 establish the minimum current Good Manufacturing Practice requirements for finished pharmaceutical products.
Question 4: What does the term 'substantial equivalence' mean in the context of FDA 510(k) submissions?
- The new device costs approximately the same as the predicate device
- The new device has the same intended use and technological characteristics as a predicate device (Correct answer)
- The new device passes the same performance tests as a predicate device
- The new device is manufactured by the same company as the predicate device
Correct answer: The new device has the same intended use and technological characteristics as a predicate device
Substantial equivalence means the new device has the same intended use and either the same technological characteristics or different ones that do not raise new safety questions.
Question 5: Under ISO 13485:2016, which party is responsible for ensuring that externally provided processes conform to requirements?
- The external provider alone
- The regulatory authority
- The organization that outsources the process (Correct answer)
- The third-party auditor
Correct answer: The organization that outsources the process
ISO 13485 clause 7.4 places responsibility on the organization to ensure outsourced processes meet specified requirements, not the supplier alone.
Question 6: In EU MDR 2017/745, what is a Unique Device Identifier (UDI) primarily designed to accomplish?
- Replace CE marking requirements for all devices
- Enable unambiguous identification and traceability of devices on the market (Correct answer)
- Serve as the device registration number for EUDAMED
- Indicate the manufacturing lot and expiry date only
Correct answer: Enable unambiguous identification and traceability of devices on the market
UDI systems enhance post-market surveillance, recall effectiveness, and adverse event reporting by enabling clear identification and traceability of medical devices.
Question 7: A company discovers that a previously released batch of product does not meet a specification. Under 21 CFR Part 820, what document must be initiated?
- A product recall notice
- A nonconformance report followed by CAPA if needed (Correct answer)
- An adverse event report to the FDA
- A design change order
Correct answer: A nonconformance report followed by CAPA if needed
21 CFR 820.90 requires documented procedures for identifying and controlling nonconforming product, and 820.100 requires CAPA when the nonconformance warrants it.
MR Regulatory Framework and Compliance 2
Under 21 CFR Part 820, what is the primary purpose of a Design History File (DHF)?