The FDA said today it has begun more closely scrutinizing the roles of certain materials associated with harm to patients who have breast implants, nitinol-containing devices, metal-on-metal hip implants and devices made from animal-derived substances. It’s the latest in a series of statements the agency has issued following increasingly harsh public criticism of its efforts […]
internationalconsortiumofinvestigativejournalists
FDA tells its side of regulatory, quality story
A week after an international group of journalists published a package of stories slamming the medical device industry, the FDA has issued its own report highlighting its accomplishments dating back to 2007. The Medical Device Enforcement and Quality Report touts: Increased medtech manufacturer inspections and voluntary reporting of violative devices and adverse events; Targeted enforcement of […]