Law360, Washington (July 05, 2012, 3:03 PM ET) -- The U.S. Food and Drug Administration announced a final rule on Thursday that will require cardiovascular permanent pacemaker electrode manufacturers to submit new information to the regulator to keep their products on the market while reducing the approval workload.
The requirement change will move the electrodes out of the current 510(k) approval process and implement premarket approval applications instead, which the agency claims will cut 2,860 hours from the approval process time per device.
In a Federal Register notice to be published Friday, the FDA said...
Pacemaker Electrodes To Switch Approval Processes At FDA
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