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 regulations regarding particular devices;
- Firms’ corrective actions following inspections; and
- The use of regulations to promote device quality, not just compliance, through its Case for Quality pilot program launched this year.