### Question
What does distinctive by design mean?


### Answer
**Distinctive by design** has the following meaning 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)**

