### Question
What does medical device mean?


### Answer
**Medical device** has the following meaning 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: **SUBCHAPTER I-PROGRAMS AND ACTIVITIES > Subchapter Referred to in Other Sections**

