MR Regulatory Framework and Compliance 2

Question 1

Under 21 CFR Part 820, what is the primary purpose of a Design History File (DHF)?

Accepted Answer

To document the history of the design of a finished device

Answer

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?

Accepted Answer

Submit a corrective action plan within 30 days addressing each observation

Answer

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?

Accepted Answer

21 CFR Part 210 and 211

Answer

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?

Accepted Answer

The new device has the same intended use and technological characteristics as a predicate device

Answer

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?

Accepted Answer

The organization that outsources the process

Answer

ISO 13485 clause 7.4 places responsibility on the organization to ensure outsourced processes meet specified requirements, not the supplier alone.

(MR) Management Representative Certification Practice Test

(MR) Management Representative Certification Practice Test

MR Regulatory Framework and Compliance 2