"FDA has the responsibility for assuring the safety and efficacy of all regulated marketed medical products."

http://www.fda.gov

"MedWatch, the FDA Safety Information and Adverse Event Reporting Program, serves both healthcare professionals and the medical product-using public. We provide important and timely clinical information about safety issues involving medical products, including prescription and over-the-counter drugs, biologics, medical and radiation-emitting devices, and special nutritional products (e.g., medical foods, dietary supplements and infant formulas).

Medical product safety alerts, recalls, withdrawals, and important labeling changes that may affect the health of all Americans are quickly disseminated to the medical community and the general public via this web site and the MedWatch E-list. Select What's New to see safety information added in the past two weeks. Select Safety Information to see reports, safety notifications, and labeling changes posted to the website since 1996.

MedWatch allows healthcare professionals and consumers to report serious problems that they suspect are associated with the drugs and medical devices they prescribe, dispense, or use. Reporting can be done on line, by phone, or by submitting the MedWatch 3500 form by mail or fax. Select How to Report for more details."

http://www.fda.gov/medwatch

"CDRH must work with a broad spectrum of stakeholders, ranging from consumers to medical professionals, to the industries we regulate. They expect us to manage risks presented by advancing technology and changing use patterns. We must do this with constant or decreasing resources. We have effective programs that we have shaped with stakeholder input. We are well underway implementing FDAMA, and we have managed scarce resources responsibly. Medical technology is changing rapidly, and our information is so vast that web page hits are measured in the millions and databases are described as "warehouses". Information systems are evolving so fast E-mails outrun the Post Office, and transform traditional communication. Scientific disciplines are merging, and the business of health care is becoming global."

"CDRH maintains information collected from device experience reports on medical devices which may have malfunctioned or caused a death or serious injury. This data is contained in the :
Medical Device Reporting (MDR) database - The MDR files contain reports received under both the mandatory Medical Device Reporting Program (MDR) from 1984 - 1996, and the voluntary reports up to June 1993. The database currently contains over 600,000 reports.
Manufacturer and User Facility Device Experience (MAUDE) database - The MAUDE data consists of all voluntary reports since June, 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August, 1996. The database currently contains about 1.2 million reports."

http://www.fda.gov/cdrh