> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Class 2 for Enzyme Packed Cartridges
- URL: https://www.fdaweb.com/class-2-for-enzyme-packed-cartridges/
- Published: 2017-10-17T12:00:00.000Z
- Updated: 2026-09-14T22:56:23.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139897

*Federal Register* notice: FDA has classified enzyme packed cartridges into Class 2 (special controls). The action is the result of a 1/2015 *de novo* submission from Alcresta, Inc. for Relizorb. The agency has named the generic type of device “enzyme packed cartridge,” and it is identified as an *ex vivo* prescription device that is used in enzymatic hydrolysis of macronutrients into their essential nutrient forms at the time of delivery. The device consists of an outer casing containing an inert polymer with a covalently bound enzyme through which nutritional formula is directed. The device fits in line with enteral feeding systems. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-10-16/pdf/2017-22286.pdf?ref=fdaweb.com).