### Question
How does the law define distinctive by design?


### Answer
Under *21 CFR § 800.12*, **distinctive by design** is defined as:

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

#### Citation:
  - *21 CFR § 800.12*
  - Heading: **PART 800—GENERAL > Subpart B—Requirements for Specific Medical Devices > SUBCHAPTER H—MEDICAL DEVICES > SUBCHAPTER H—MEDICAL DEVICES**

