Exam (elaborations)
FDA AND PRODUCT CLASSIFICATION-REGULATION, ADULTERATION-MISBRANDING
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FDA AND PRODUCT CLASSIFICATION-REGULATION, ADULTERATION-MISBRANDING
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FDA AND PRODUCT CLASSIFICATION/REGULATION,ADULTERATION/MISBRANDING
What all does the FDA regulate? (5) - Answers- Human/Veterinary drugs, biological
products
Medical devices
Nation's food supply
Cosmetics
Products that emit radiation
The FDA does NOT regulate... (3) - Answers- Water
Meat
Poultry
What does cosmetics NOT require? (2) - Answers- Pre-market approval by the FDA
-> manufacturers don't have to register w/ FDA, only have to prove that product is
sanitary
Does NOT have to conform to good manufacturing processes
How must ingredients be listed in cosmetics? - Answers- In defending order of
predominance
Devices do not... - Answers- achieve their intended purpose via chemical action or
metabolism in the body
What is a class I device? (3) - Answers- Requires least regulation
Pose LEAST potential harm to users
Manufacturers must register with FDA
Examples of class I devices - Answers- stethoscope, scissors, toothbrushes, ventilator
tubing, tongue depressor
What is a class II device? - Answers- Must be specific performance standards
, Examples of class II devices - Answers- Syringes, tampons, condoms, hemoglobin A1C
immunoassays, BP monitors, insulin syringes
What is a class III device? - Answers- Must have pre-market approval
Examples of class III devices - Answers- Pacemakers, replacement heart valves and
soft contact lenses, drug-eluding stents
What are some devices that are Rx only? - Answers- Spacers, nebulizers, diaphragms
Is the following a food, drug, dietary supplement, special dietary food, medical food,
device, or cosmetic: Whey Protein Powder - Answers- Dietary supplement, general
well-being claims
Is the following a food, drug, dietary supplement, special dietary food, medical food,
device, or cosmetic: Vitamin B12 injection - Answers- Drug
(supplement can only be PO)
Is the following a food, drug, dietary supplement, special dietary food, medical food,
device, or cosmetic: Under arm deodorant - Answers- Cosmetic
Is the following a food, drug, dietary supplement, special dietary food, medical food,
device, or cosmetic: Under arm deodorant/anti-perspirant - Answers- Drug... also a
cosmetic but FDA goes by most strict
Is the following a food, drug, dietary supplement, special dietary food, medical food,
device, or cosmetic: Foltx tablets (B12/folic acid/B6, 'for dietary management of
hyperhomocysteinemia' - Answers- Medical food
Management of specific disease state
Is the following a food, drug, dietary supplement, special dietary food, medical food,
device, or cosmetic: OraQuick At Home HIV test - Answers- Medical device
Used to diagnose
Is the following a food, drug, dietary supplement, special dietary food, medical food,
device, or cosmetic: No-salt salt substitute - Answers- Special dietary food
Is the following a food, drug, dietary supplement, special dietary food, medical food,
device, or cosmetic: Feverfew herbal supplement... 'for the prevention of migraines' -
Answers- Drug
Prevention of disease state
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