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# Pfizer’s Changes to Total Lifecycle Patient Preference Guide
- URL: https://www.fdaweb.com/pfizers-changes-to-total-lifecycle-patient-preference-guide/
- Published: 2024-10-24T12:00:00.000Z
- Updated: 2026-09-14T14:44:57.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158051

Pfizer has submitted several pages of specific line-by-line comments in response to an FDA draft guidance on “incorporating voluntary patient preference information over the total product lifecycle.” Among its recommendations are:

- revise the guidance title to reflect that it focuses on patient preference information relating to medical devices;
- add a specific section on the analysis of quantitative patient preference data addressing several specific issues;
- reference the lifecycle approach to benefit/risk assessment as one reason for considering patient preference information across the total product lifecycle;
- provide a reference for understanding the concepts of maximum acceptable risk and minimal acceptable benefit;
- revise the guidance statement on conditions of use; and
- include in the FDA decision summary the reason why FDA did not consider any study that was submitted but not considered.