Manufacturer-FDA Relations Need Change, Says Harkin
Sen. Tom Harkin (D-Iowa) says that the FDA conducts its approval process with minimal resources and does not have adequate funds to “genuinely ensure [medical] devices are safe, or to properly and effectively reevaluate approvals as new information becomes available.” He says that the FDA expects manufacturers to provide information about their products and once those products are on the market, it expects the manufacturers to track and monitor for any problems. He believes that without the threat of product liability, there is not much incentive for manufacturers to report any problems found to the FDA or the public. (0:39)
August 4, 2009
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