### Question
How is the "real-time supplement" defined?


### Answer
The term **real-time supplement** is defined in *21 U.S.C. § 379i* as follows -

> a supplement to an approved premarket application or premarket report under section 360e of this title that requests a minor change to the device, such as a minor change to the design of the device, software, manufacturing, sterilization, or labeling, and for which the applicant has requested and the agency has granted a meeting or similar forum to jointly review and determine the status of the supplement

#### Citation:
  - *21 U.S.C. § 379i*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER VII-GENERAL AUTHORITY > Part C-Fees > subpart 3-fees relating to devices**

