Researchers studied an FDA's list of recalled devices from 2005-2009 and found a large majority of medical devices recalled for life-threatening or serious hazards were cleared using the 510(k) process, which is intended for devices that the FDA deems as low- or moderate risk, according to a study published in Archives of Internal Medicine.
Of the 113 recalls from 2005-2009, only 21 medical devices had been approved through the premarket approval process, which requires clinical testing and inspections. Another 80 medical devices were approved through the 510(k) process, and another eight devices were exempt from any FDA clearance.
The largest recall category was cardiovascular devices, with 35 high-risk recalls. Of these recalls, 66 percent were cleared through the less-stringent 510(k) process.
Read the abstract about medical devices.
Read other coverage about medical devices:
- Trend: Wireless Medical Devices Can Help Contain Healthcare Costs
- FDA Awards Contract to Develop Sentinel System Pilot for Evaluating Medical Product Safety
- AAMI Urges Federal Agencies to be More Engaged in Developing Medical Device Standards
Of the 113 recalls from 2005-2009, only 21 medical devices had been approved through the premarket approval process, which requires clinical testing and inspections. Another 80 medical devices were approved through the 510(k) process, and another eight devices were exempt from any FDA clearance.
The largest recall category was cardiovascular devices, with 35 high-risk recalls. Of these recalls, 66 percent were cleared through the less-stringent 510(k) process.
Read the abstract about medical devices.
Read other coverage about medical devices:
- Trend: Wireless Medical Devices Can Help Contain Healthcare Costs
- FDA Awards Contract to Develop Sentinel System Pilot for Evaluating Medical Product Safety
- AAMI Urges Federal Agencies to be More Engaged in Developing Medical Device Standards