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21 Questions On 21 CFR Part 820
21 Questions On 21 CFR Part 820
Enter your
response as
N – True or
o. Question False
The FDA exempts startups / small manufacturers from
compliance requirements for the first year of
1 operation
2 21 CFR 820 requires conformance with ISO 13485
The qualifying term “where appropriate” as used in
the regulation means a requirement is deemed
“appropriate” unless the manufacturer can justify
3 otherwise
ISO 13485 requires the appointment of a Management
Representative, however, it is not a requirement
4 under the regulation
Component means any piece, part, or sub-assembly
that becomes part of the finished device; raw
5 materials are not considered components
Design outputs need to include a go to market plan
6 and how it will be executed for the device in question
Finished device is a device that is suitable for use or
can function – regardless of whether or not it is
7 packaged, labeled, or sterilized
Manufacturing materials are same as raw materials
8 intended for inclusion in the device
9 In-process devices are considered Product
Quality is defined as a device that meets all customer
10 requirements
11 Validation and verification are two words that mean
the same
12 UDI means Universal Device Identifier
13 UPC means Universal Product Code
14 DHF is the Device History File
15 DMR is the Device Master Record
HCT/P is Human cell, tissue, or cellular or tissue-based
16 product
A device that is Class I and has automated software
17 applications built into it will require design controls
18 QSR means Quality System Requirement
Manufacturers are required to keep track of the final
19 consignee of their products
20 Every complaint shall be investigated
Class I, II, and III recalls are linked to Class I, II, and III
devices respectively (i.e. Class I recall applies only to
21 Class I device, etc.)
Answer Key
Questions with correct answer as True: 3, 7, 9, 13, 15, 16, 17
All others: False
Your score – total number of questions you answered correctly: ___
Interpreting Your Score
0–5 Get help right away
6 – 11 Some understanding with lot of room to improve
12 – 17 You are getting there, continue your journey
18 – 21 Wonderful! Don’t let up on the good work