Radiation
Regulations
Damage
100

The movement of energy via waves and particles

What is Radiation
100

The branch of the FDA that governs radiation-emitting devices 

What is the Center for Devices and Radiological Health, or CDRH

100

This high-energy electromagnetic wave can penetrate through lead and concrete and can ionize DNA

What is Gamma Radiation
200

This common household device shares its name with a type of radiation

What is a Microwave

200

The first step in regulating a product to CDRH

What is Establishing the Product

200
Highly concentrated beams of light that can damage the eye

What is a laser

300

This organ is a radiation detector

What are the Eyes

300

The standard regulatory pathway for low- to medium-risk devices 

What is 501(k) or premarket notification

300

Prolonged exposure to this form of ultraviolet radiation can cause damage to DNA in your dermis 

What is UVB

400

CRT TVs use this type of radiation

What is Ionizing Radiation or X-rays

400

De Novo is an alternative to PMA, which is used when

CDRH hasn't regulated a product like the proposed product

400

Fast-moving electrons that can penetrate the skin but not clothing

what is Beta radiation

500

Suppose you are given three radioactive cookies: one is an alpha emitter, one is a beta emitter, and one is a gamma emitter. You must eat one, hold one in your hand, and put the other one in your pocket. Explain your reasoning

Hold the Alpha cookie in your hand because it cannot penetrate skin

Put the Beta cookie in your pocket because it cannot penetrate through clothing

Eat the Gamma cookie because it penetrates through you

500

The United States Federal, Food, Drug, and Cosmetic Act, Chapter 5, Subchapter C, Electronic and Radiation Control, was previously known as this

What is Radiation Control for Health and Safety Act of 1968, or RCHSA

500

Short exposure to this type of radiation can cause burns and irritation to the skin and eyes

What is UVC