FDA Issues a Report on Increased Medical Device Inspections and Improved Compliance
The Report highlights:
- Annual device inspections have increased 46% since 2007
- The annual number of foreign device inspections have increased 243% since 2007
- The Agency is taking a targeted, risk-based enforcement approach to address specific device areas of concern. Case studies mentioned in the report are:
- Infusion Pumps
- Automated External Defibrillators
- Radiation Therapy Devices
- From 2008 to 2007, 82% of firms corrected observed violations on follow-up inspections.
- The FDA is also continuing to promote device quality through the Case for Quality initiative.
For related reading based on our involvement with the Case for Quality, please see: