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Aligning Medicare payment rates for vacuum erection systems with those of other insurers could have saved the government $14.4 million and beneficiaries about $3.6 million yearly over a six-year period, a new report by HHS’ Office of Inspector General concludes. Read More
The FDA’s new custom device exemption, granted under FDASIA, does not apply to 510(k)-cleared devices that are modified but still retain their original intended use and could be clinically studied, the agency clarifies in a draft guidance. Read More
The FDA’s budget would be set at $4.35 billion, an increase of $91 million from 2013, under an omnibus spending bill passed by Congress last week. Read More
While all FDA device investigators go through specialized training, combination products and foreign inspections can still pose challenges during the inspection process. Read More
Members of the Council of Europe are at odds over whether to allow reprocessing of single-use devices, and the disagreement could upend efforts to pass device reform legislation before EU elections in May. Read More
A recent appeals court hearing on the Securities and Exchange Commission’s conflict minerals disclosure rule provided no immediate relief for manufacturers — though the line of questioning suggested some judges were sympathetic to industry’s free speech argument against the rule. Read More
China’s National Health and Family Planning Commission plans to “blacklist” devicemakers convicted of bribing government officials and ban sales of their products for two years — four for repeat offenses. Read More