### Question
What is the definition of distinctive by design?


### Answer
The definition of **distinctive by design** is as follows in *21 CFR § 800.12*:

> the package cannot be duplicated with commonly available material or through commonly available processes

#### Citation:
  - *21 CFR § 800.12*
  - Heading: **Title 21—Food and Drugs > PART 800—GENERAL > Subpart B—Requirements for Specific Medical Devices > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)**

