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ISOs and HTMs across the U.S. issue strong opposition to FDA registration proposition

An editorial by Robert Kerwin, General Counsel, IAMERS

Independent servicers across the nation have registered with their congressional representatives strong disapproval to the proposed independent servicers legislation.

Independent servicers from California, Illinois, Tennessee, Georgia, Alabama, Indiana, New Jersey, North Carolina, South Carolina, Louisiana, Ohio, Missouri, West Virginia, Kentucky, Maryland, Michigan, Florida and New York have requested that the legislation be opposed.

Some have noted the potential job loss. Others have cited the possible effect on regional and rural America.

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“In all my years with IAMERS I have not encountered an issue which has galvanized our members more," commented IAMERS president, Diana Upton. "We care about patient safety and strongly believe that Congress should not rely upon anecdotal information to conclude a problem exists.”

The American College of Clinical Engineers has also expressed the view that “any regulation that affects the safety and cost effectiveness of the application of medical technology to patient care should not be entered into without evidence of a problem that needs to be remediated. This bill is attempting to address an alleged patient safety problem for which no scientific evidence exists.”

Members of the electrical contractors association are also examining the legislation as it would seem to require, if approved, electricians who work on medical devices to be registered. This would certainly also change the equilibrium.

The U.S. House of Representatives Subcommittee on Health will vote on Thursday, May 18, whether or not to advance the 2017 FDA Reauthorization Act of 2017 (MDUFA IV).

The current version of the legislation, H.R. 2430 does not have the "servicer registration" provisions which were the subject of a hearing on May 2, 2017.

There are four possible amendments to be considered as of publication of this article, but none reference servicer registration. Still, according to agreed to procedural requirements of the Subcommittee a member may offer amendments up to two hours prior to a subcommittee hearing.

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