Comments on Intent to Exempt Certain Medical Devices from Premarket Notification Requirements

We strongly urge the FDA to reassess the Submission Type for certain medical devices and continue to require 510(K) clearance due to the high number of MAUDE reports, including numerous deaths from these devices. Devices that can cause fatal adverse events should not be exempt from FDA regulation. Continue reading

Comments on Distributing Risk Information for Approved Prescription Drugs and Biological Products

August 25, 2014. As members of the Patient, Consumer and Public Health Coalition, we strongly urge the Food and Drug Administration (FDA) to withdraw its draft guidance proposing to allow pharmaceutical firms to distribute to health care providers and facilities scientific medical literature suggesting that the risk information for prescription drugs and biological products are less than what is stated in the FDA-approved product labeling. Continue reading