RAC Quality System Regulation 2

Question 1

Under 21 CFR Part 820, which document must be established for each type of device and include or refer to the device specifications and production processes?

Accepted Answer

Device Master Record (DMR)

Answer

The Device Master Record (DMR) must be established and maintained for each type of device and includes all specifications and procedures required for production.

Question 2

A medical device manufacturer discovers that a nonconforming product was inadvertently distributed. According to 21 CFR Part 820, this event most likely triggers which procedure?

Accepted Answer

Recall and field action procedure

Answer

Distribution of nonconforming product requires activation of recall and field action procedures under 21 CFR Part 820.100 and related sections.

Question 3

Which 21 CFR Part 820 requirement mandates that manufacturers establish procedures to ensure that purchased or received product conforms to specified requirements?

Accepted Answer

Purchasing controls (§820.50)

Answer

Purchasing controls under §820.50 require that manufacturers evaluate and select suppliers and establish procedures to ensure incoming materials meet specified requirements.

Question 4

According to 21 CFR Part 820, how long must a manufacturer retain the Device History Record (DHR) after the last date of manufacture?

Accepted Answer

2 years or the expected life of the device, whichever is greater

Answer

21 CFR §820.180 requires that records be retained for a period equivalent to the expected life of the device or 2 years from the date of release, whichever is greater.

Question 5

Management review under 21 CFR Part 820 must be conducted with sufficient frequency to ensure that the quality system is:

Accepted Answer

Suitable and effective for its stated purposes

Answer

§820.20 requires management review to be conducted with sufficient frequency to ensure the quality system remains suitable and effective.

(RAC) Regulatory Affairs Certification Practice Test

(RAC) Regulatory Affairs Certification Practice Test

RAC Quality System Regulation 2