FDA 21 CFR 820 - How much do you know?
Test Your Knowledge on FDA 21 CFR 820
Are you familiar with the FDA's regulations for medical devices? This engaging quiz will challenge your understanding of 21 CFR 820 and related concepts.
Key points to explore:
- FDA compliance requirements
- Quality System Regulation (QSR)
- Device classification and management
The FDA exempts startups / small manufacturers from compliance requirements for the first year of operation
True
False
21 CFR 820 requires conformance with ISO 13485
True
False
The qualifying term “where appropriate” as used in the regulation means a requirement is deemed “appropriate” unless the manufacturer can justify otherwise
True
False
ISO 13485 requires the appointment of a Management Representative, however, it is not a requirement under the regulation
True
False
Component means any piece, part, or sub-assembly that becomes part of the finished device; raw materials are not considered components
True
False
Design outputs need to include a go to market plan and how it will be executed for the device in question
True
False
Finished device is a device that is suitable for use or can function – regardless of whether or not it is packaged, labeled, or sterilized
True
False
Manufacturing materials are same as raw materials intended for inclusion in the device
True
False
In-process devices are considered Product
True
False
Quality is defined as a device that meets all customer requirements
True
False
Validation and verification are two words that mean the same
True
False
UDI means Universal Device Identifier
True
False
UPC means Universal Product Code
True
False
DHF is the Device History File
True
False
DMR is the Device Master Record
True
False
Not all product defects should cause CAPA. Isolated incidents can be dealt with through minor corrections.
True
False
A device that is Class I and has automated software applications built into it will require design controls
True
False
QSR means Quality System Requirement
True
False
All manufacturers are required to keep track of the final consignee of their products
True
False
Every complaint shall be investigated
True
False
Class I, II, and III recalls are linked to Class I, II, and III devices respectively (i.e. Class I recall applies only to Class I device, etc.)
True
False
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