21 Questions on 21 CFR Part 820 (Quality
System Regulation) Test Your Awareness!
Rai Chowdhary
Wednesday, November 30, 2016
Much information is now available on the web and it is said that one does not have
to memorize that much anymore. While that is true, there are certain things one just
needs to know without having to lookup the source constantly. As an analogy – you
cannot fly a plane by referring to the user manual continuously during flight. The
steps, processes, and actions need to just flow from knowledge that has been
internalized.
When it comes to medical devices, certain points regarding the applicable
regulations (21 CFR 820 as an example) and industry standards (such as ISO 13485)
should be common knowledge amongst key staff and leaders of such firms. Of
course – if there is doubt – one should refer to the source.
Here is a handy self-assessment tool for you to determine your current
understanding. Several questions below pertain to definitions (contained in the
regulation) – since they are the starting point of knowledge assimilation.
Take a test drive (while resisting the temptation to look up the answers on the web
or other resources) bearing in mind that it is not an exhaustive or complete listing.
Answers and scoring schema are at the bottom of this page; explanation and
comments are available on our website: www.bioutah.org/xyz...
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
