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# Rule on Device GMP Requirements Corrected
- URL: https://www.fdaweb.com/rule-on-device-gmp-requirements-corrected/
- Published: 2024-10-11T12:00:00.000Z
- Updated: 2026-09-14T14:43:52.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5157965

*Federal Register* notice: FDA is correcting a 2/2 final rule on device GMP requirements under the Quality System regulation. It erroneously omitted the definition of “batch” or “lot” that is now being added as follows: “Batch or lot means one or more components or finished devices that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits.” To view the notice, click [here](https://public-inspection.federalregister.gov/2024-23701.pdf?ref=fdaweb.com).