Advertising, Promotion, and Labeling for Medical Devices and IVDs (Ch. 8)

Question 1

What is the definition of a “label”?

Answer 1

Label:
A display of written, printed, or graphic material on the immediate container of any “article” (refers to a medical device or IVD)

Question 2

What is the definition of “labeling”?

Answer 2

Labeling:
A broader term that refers to any written, printed, or graphic material on any article, on any of its containers or wrappers, or on any material accompanying it
(Includes any form of promotion, such as instructional posters, booklets, instruction or direction sheets, operating manuals, etc. as well as labeling intended to be used in promotional activities (promotional labeling))

Question 3

What is the regulation for general device labeling?

Answer 3

21 CFR Part 801: General Device Labeling

Question 4

What is the regulation for UDI?

Answer 4

21 CFR 830: Unique Device Identification

Question 5

TRUE/FALSE: Booklets, instruction sheets, and sales sheets are considered labels.

Answer 5

FALSE: Booklets, instruction sheets, and sales sheets fall under “labeling”.

Question 6

What are the two types of labeling recognized by the FDA?

Answer 6

FDA-approved labeling (for a PMA, BLA, or NDA) and promotional labeling

Question 7

What are the required elements for device labeling?

Answer 7

1. Directions for use
2. Operating and service instructions
3. Warnings when the device’s use may be dangerous to health
4. Any information to protect the user

Question 8

What is included in the basic label/labeling outline?

Answer 8

1. Manufacturer, packer, or distributor name and principal place of business
2. Device name
3. Description
4. Indications and usage
5. Contraindications
6. Warnings and precautions
7. Specific patient population
8. Adverse reactions (if applicable)
9. Date of issue or latest revision of labeling bearing information for use

Question 9

What does UDI stand for?

Answer 9

UDI:

Unique Device Identification

Question 10

What is the purpose of the UDI final rule (2013)?

Answer 10

To identify medical devices throughout their lifecycles

Question 11

What are the two components of a UDI?

Answer 11

DI + PI
DI: Device Identifier
PI: Production Identifier

Question 12

What is a UDI DI?

Answer 12

DI: Device Identifier

Identifies the labeler and the device model

Question 13

What is a UDI PI?

Answer 13

PI: Production Identifier
Identifies production information, including lot or batch number, serial number, expiration date, manufacture date, and a distinct ID code for HCT/P devices

Question 14

What website are device labelers required to enter UDI information?

Answer 14

GUDID: FDA’s Global Unique Device Identification Database

Question 15

What is the regulation for labeling requirements?

Answer 15

21 CFR 801: LABELING

Question 16

What are “adequate directions for use”?

Answer 16

Directions under which the layman can use a device safely and for the purposes intended

Question 17

What is the definition of principal display panel?

Answer 17

Principal display panel:
The portion of the label which is intended to be displayed, presented, shown, or examined under customary conditions for retail sales.

Question 18

What are the labeling requirements for over-the-counter (OTC) devices?

Answer 18

1. The statement of identity of the device must be listed on the principal display panel
2. A statement of the net quantity of content

Question 19

What elements are included in the statement of identity?

Answer 19

• The name of the device
• Intended action
• Indications for use as part of the directions for use
  (Must be in bold type, reasonable size)

Question 20

What is a net quantity of contents statement?

Answer 20

Net quantity of contents must be stated, in terms of:
- Count
- Measure
- Weight 
(Should appear as a separate item)