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# Comments Sought on Device Recordkeeping Requirements
- URL: https://www.fdaweb.com/comments-sought-on-device-recordkeeping-requirements/
- Published: 2016-09-08T12:00:00.000Z
- Updated: 2026-09-14T21:30:28.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136734

*Federal Register* Notice: FDA seeks comments on recordkeeping requirements related to the medical devices current good manufacturing practice quality system regulation. The CGMP/QS regulation includes requirements for purchasing and service controls, clarifies recordkeeping requirements for device failure and complaint investigations, clarifies requirements for verifying/validating production processes and process or product changes, and clarifies requirements for product acceptance activities quality data evaluations and corrections of nonconforming product/quality problems. Comments should be submitted by 11/7\. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-09-08/pdf/2016-21553.pdf?ref=fdaweb.com)