FDA requests safety, effectiveness information from medical device makers

ROCKVILLE, Md. The Food and Drug Administration on Wednesday announced that manufacturers of 25 types of medical devices marketed prior to 1976, including the female condom, must submit safety and effectiveness information to the agency so that it may evaluate the risk level for each device type.

Devices found by the FDA to be of high risk to consumers will be required to undergo the agency’s most stringent premarket review process.

“We are taking the necessary steps to complete this very complex process while continuing to protect public health by thoroughly reviewing and evaluating all medical device submissions presented to the agency,” stated Daniel Schultz, director of the FDA’s Center for Devices and Radiological Health. “New premarket notification submissions for devices of these 25 types will continue to receive an appropriate level of scrutiny to ensure safety and effectiveness.”