FDA Meeting – FDA’s Communications About the Safety of Medical Devices

By Gabriela Salas

Oral Presentation Delivered to the Center for Devices and Radiological Health Virtual Public Meeting

November 17, 2020

[Docket No. FDA-2020-N-0096]

 

TRANSCRIPT:

Thank you for the opportunity to provide oral comments. My name is Gabriela Salas. I am the Health Policy Fellow at the National Women’s Health Network, a nonprofit advocacy organization that has been bringing the voices of women to the FDA for 45 years. We are supported by our members and do not accept financial support from drug or device makers. I have no conflicts of interest to disclose. 

When it comes to clinical trials of new drugs and medical devices, all too often, it’s still a man’s world. For decades, most biomedical research focused on men, specifically white men, even for medical devices intended for use by both men and women. FDA has encouraged device makers to include women and people of color in clinical trials, but without any consequences for failure to comply, progress has been slow.  Women are now included in most trials of new drugs, but they are less likely to be included in sufficient numbers in trials of medical devices. And when they are included, the data can be difficult to navigate and the information on how a medical device impacts women is not always accessible to patients.

A critical part of communicating medical device safety information to patients  is letting them know if those devices have been tested in people like them. The Network strongly urges FDA to replicate the successful Drug Trial Snapshots and publish a clinical trial snapshot for every FDA-cleared medical device. This will provide the necessary data and information needed for patients to make proper, and informed, decisions for their own health and safety, in an accessible and absorbable manner.

Thank you again for your consideration.