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# CDRH, CDER Differ on Releasing Gender Info
- URL: https://www.fdaweb.com/cdrh-cder-differ-on-releasing-gender-info/
- Published: 2019-12-05T12:00:00.000Z
- Updated: 2026-09-14T15:55:34.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5145661

The CDRH Manufacturer and User Facility Device Experience (MAUDE) database does not make public information on the sex of patients involved in a medical device adverse event for reasons of “patient confidentiality.” However, the CDER FDA Adverse Events Reporting System (FAERS) makes such information publicly available.

Because the International Consortium of Investigative Journalists (ICIJ) wanted to know if more women were hurt by medical devices than men, it countered the agency’s unwillingness to provide the gender data by partnering with artificial intelligence experts at Stanford University to develop an algorithm to identify the gender of patients in adverse events reports through looking at pronouns and adjectives used in the reports.

ICIJ [says](https://www.icij.org/investigations/implant-files/we-used-ai-to-identify-the-sex-of-340000-people-harmed-by-medical-devices/?ref=fdaweb.com) it was able to positively identify the sex of the patient in more than 340,000 medical device injury and death cases, and found that 67% were women and 33% men. “It is impossible to generalize the findings about patient sex to the entire universe of injuries and deaths reported to MAUDE,” ICIJ says, “but the results do serve as additional evidence of a patient-sex imbalance that experts say FDA is not doing enough to explore.”

Commenting on the ICIJ report, *MassDevice* says in an online [post](https://www.massdevice.com/report-more-women-harmed-by-medical-devices-than-men/?ref=fdaweb.com) that an FDA spokesperson said “the platform on which our MAUDE database runs is outdated and has limited functionalities, which is one of the reasons we have pushed for funding to improve our IT infrastructure for the past several years. Congress recently gave us additional funding for this purpose, and we are in the process of a digital transformation to build a modern platform that will allow us to make more information readily available and easier to access.”

The spokesperson also pointed to steps FDA has undertaken to better understand how medical devices perform in women and to explore unique issues in the regulation of medical devices related to the health of women. Those activities are said to include **(1)** the CDRH Health of Women Program to address the steadily growing importance of sex- and gender-specific issues arising regarding medical technology design and development; **(2)** the Center’s work with health professional organizations, patient groups, and others to establish a Health of Women Technologies Coordinated Registry Network; and **(3)** a recent FDA immunology panel meeting on implants that included public testimony and review of the scientific evidence about immunological responses to select metals in medical devices, including their impact on women’s health.

Left unsaid was whether the agency would begin to have CDRH release the data on factors such as age, sex, and the outcome of an adverse event that is currently redacted by CDRH but not by CDER.