Powered Wheeled Stretchers Now 510(k)-Exempt
Manufacturers won’t need to submit 510(k)s for powered wheeled stretchers under a new order from the US FDA.
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A group of manufacturers and clinicians is asking the US agency to allow more discussion between manufacturers, labs and clinicians of how genetic factors could influence drug effectiveness – an area known as pharmacogenomics (PGx). The FDA had previously taken several steps to limit these communications.
The US FDA says Bayer has successfully recovered unsold Essure units and completed enrollment in a Sec. 522 postmarket study, fulfilling deadlines set at a year from the date the devices were taken off the US market.
The US FDA draft guidance dated 13 January lays bare what the agency wants to see in 510(k)s for peripheral percutaneous transluminal angioplasty (PTA) balloons and specialty catheters, such as infusion catheters and balloon catheters for in-stent restenosis (ISR).