NRC Comment on a FDA Guidance on the Evaluation of Sex Differences in Medical Device Clinical Studies

The National Research Center for Women and Families has been a long-time advocate of medical device clinical studies including data on safety and effectiveness for women. In this comment letter to the FDA, we describe the importance of analyzing data for women separately and how this information should be used to help women and providers make the best informed decisions. Continue reading

Comments on Proposed Rule: Cardiovascular Devices; Reclassification of External Pacemaker Pulse Generator Devices

January 17, 2012. As members of the Patient, Consumer, and Public Health Coalition, we strongly oppose the reclassification of External Pacemaker Pulse Generator Devices (Product code DTE) from class III (high risk devices) to class II (moderate risk devices). These devices are among the “pre-amendment” class III devices, which have been cleared by the less-than rigorous 510(k) process. External Pacemaker Pulse Generator Devices should remain class III devices and they should require Premarket Approval Applications (PMAs) because they are life-sustaining devices. Continue reading

FDA needs to provide breast implant patients and physicians with unreported industry data about quality of life, connective tissue symptoms, rupture rates per patient, and other complications

January 5, 2012 Dr. Jeffrey Shuren, Director Center for Devices and Radiological Health Food and Drug Administration Silver Spring, MD 20993 RE: FDA Needs to Provide Breast Implant Patients and Physicians with Unreported Industry Data about Quality of Life, Connective … Continue reading

Letter to Dr. Margaret Hamburg, FDA Commissioner, regarding maintaining and strengthening conflict of interest policies for advisory committees

August 3, 2011. In this letter to FDA Commissioner, Dr. Margaret Hamburg, NRC and other coalition members advocate for stronger conflict of interest requirements for members of FDA advisory committees to protect patients and consumers against industry biases. Continue reading