### Question
Can you define what medical device means?


### Answer
**Medical device** is defined as the following in *42 U.S.C. § 7671*:

> any device (as defined in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)), diagnostic product, drug (as defined in the Federal Food, Drug, and Cosmetic Act), and drug delivery system—


(A) if such device, product, drug, or drug delivery system utilizes a class I or class II substance for which no safe and effective alternative has been developed, and where necessary, approved by the Commissioner

#### Citation:
  - *42 U.S.C. § 7671*
  - Heading: **CHAPTER 83-ENERGY EXTENSION SERVICE > SUBCHAPTER VI-STRATOSPHERIC OZONE PROTECTION**

