RAC Quality System Regulation 3

Question 1

Under 21 CFR Part 820, the Design History File (DHF) must contain or reference which of the following?

Accepted Answer

All records necessary to demonstrate that the design was developed in accordance with the approved design plan

Answer

§820.30(j) requires the DHF to contain or reference all records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of Part 820.

Question 2

Which 21 CFR Part 820 section specifically addresses the requirement to identify, document, validate, and monitor software used as part of production or quality systems?

Accepted Answer

§820.70(i) — Automated processes

Answer

§820.70(i) requires validation of software used in production or quality systems, including establishing protocols for changes to that software.

Question 3

When a manufacturer transfers a design to production, 21 CFR Part 820 requires which activity to ensure the device can be produced using the approved design?

Accepted Answer

Design transfer

Answer

§820.30(h) requires design transfer procedures to ensure that the device design is correctly translated into production specifications.

Question 4

A manufacturer receives a complaint that a device caused patient injury. Under 21 CFR Part 820, the complaint file must include all of the following EXCEPT:

Accepted Answer

Name and address of the manufacturer's CEO

Answer

§820.198 requires complaint files to include the complaint date, complainant identity, device identification, investigation results, and corrective action — the CEO's identity is not required.

Question 5

Under 21 CFR Part 820, which type of device is EXEMPT from design control requirements?

Accepted Answer

Class I devices that are not life-sustaining or life-supporting and have no substantial risk

Answer

§820.30(a) exempts certain Class I devices — specifically those not life-sustaining or life-supporting, not for a use substantially important to health, and not presenting a risk of serious injury — from design control requirements.

(RAC) Regulatory Affairs Certification Practice Test

(RAC) Regulatory Affairs Certification Practice Test

RAC Quality System Regulation 3