Quiz · QMSR 1/3

FDA QMSR Overview

10 questions80% to pass

Haven't watched this lesson yet? Watch it first (15:25).

1Which U.S. regulation was revised and renamed as the Quality Management System Regulation?Choose one

21 CFR part 11 21 CFR part 820 21 CFR part 803 21 CFR part 806

2What was a principal reason FDA revised its medical-device Quality System Regulation?Choose one

To align the U.S. QMS framework more closely with ISO 13485 To eliminate FDA-specific requirements for device manufacturers To make third-party ISO certification a condition of every FDA inspection To replace medical-device quality management with product testing alone

3What was the effective date of the QMSR?Choose one

February 2, 2024 January 1, 2025 February 2, 2026 January 1, 2027

4Which pair of standards is incorporated by reference in the QMSR as explained by FDA?Choose one

ISO 9001:2015 and ISO 14971:2019 ISO 13485:2003 and ISO 9000:2015 in full ISO 9001:2015 and IEC 62304:2006 ISO 13485:2016 and clause 3 of ISO 9000:2015

5Which factors does FDA identify as relevant when documenting a manufacturer’s QMS?Select all that apply

Risk and complexity of the medical device Complexity and risk of manufacturing processes The company’s preference to disregard a regulatory requirement The company’s size and organizational makeup

6You need to locate FDA’s additional requirements for control of records. Which section in the presentation’s Part 820 outline would you consult?Choose one

Section 820.7 Section 820.35 Section 820.10 Section 820.45

7Which sequence correctly places definitions in their regulatory hierarchy, from highest to lowest priority?Choose one

ISO 9000 → ISO 13485 → FDA regulations → FD&C Act FDA regulations → FD&C Act → ISO standards FD&C Act → FDA regulations/QMSR → incorporated ISO standards ISO 13485 → FD&C Act → FDA regulations

8A manufacturer with an ISO 13485 certificate is exempt from FDA QMSR inspections.Choose one

True False

9If ISO 13485 is revised in the future, how does the FDA presentation describe the effect on QMSR?Choose one

FDA evaluates the revision and may update QMSR through rulemaking Every new ISO edition automatically becomes U.S. regulation The manufacturer chooses which ISO edition becomes legally binding Future ISO revisions permanently cancel FDA’s incorporated requirements

10A colleague says that incorporating ISO 13485 removed all FDA-specific provisions from Part 820. What is the best response?Choose one

That is true for manufacturers with fewer than 10 employees That is true if the company has ISO certification QMSR retains FDA-specific provisions alongside the incorporated standard FDA-specific provisions now apply only to clinical investigations