The FDA has called for stricter regulations against unsafe products in light of thousands of patient lawsuits concerning faulty hip implants and vaginal mesh, according to a report by Bloomberg Businessweek.
House Democrats recently introduced legislation allowing the FDA to reject devices modeled on previous products that were recalled for safety flaws. The agency currently does not have that authority in every case, which can lead to a question in credibility of some approved devices.
The Advanced Medical Technology Association, meanwhile, argued that the proposed bill would add regulatory burdens for manufacturers who already struggle with lengthy FDA reviews.
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House Democrats recently introduced legislation allowing the FDA to reject devices modeled on previous products that were recalled for safety flaws. The agency currently does not have that authority in every case, which can lead to a question in credibility of some approved devices.
The Advanced Medical Technology Association, meanwhile, argued that the proposed bill would add regulatory burdens for manufacturers who already struggle with lengthy FDA reviews.
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