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

21 Questions5 MinutesCreated by ExaminingEagle347

The FDA exempts startups / small manufacturers from compliance requirements for the first year of operation

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

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

All manufacturers are required to keep track of the final consignee of their products

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

FDA 21 CFR 820 - How much do you know?

Test Your Knowledge on FDA 21 CFR 820

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