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Senate FDA user fee package excludes ISO registration

By Robert J. Kerwin
IAMERS General Counsel


The FDA Medical Device User Fee Amendments (MDUFA IV) package is heading to a Senate committee vote — and it appears not to include any of the House legislative language on independent servicer registration.

Today’s Senate mark-up of the package was delayed, but is expected shortly. Currently, the Senate amendment includes riders on over-the-counter hearing aids, risk-based device inspections, and several other amendments also considered recently by the House during the hearing on the servicing legislation.

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Notably absent from the Senate amendments is language which would require independent service organizations (ISOs) to register with the FDA.

When the House and Senate approve measures in their respective chambers, a conference committee is often formed to resolve differences in the two measures. A conference committee will likely occur on the FDA User Fee package as this is a major legislative initiative for both House and Senate.

The House Energy & Commerce Committee has yet to introduce its reauthorization. This week the House is in recess and will return next week. IAMERS members have been contacting their Congressional representatives and members of the House Subcommittee on Health to express their strong opposition to the registration bill, and will welcome continued efforts by ISOs to voice their concern.

Robert J. Kerwin
Without any real-world evidence to support a change, the House registration bill would require ISOs to register with the FDA and adopt complaint handling systems similar to those implemented by original equipment manufacturers (OEMs). Making ISOs report like OEMs does not reduce health care costs or advance competition and many independent servicers see the measure as a red herring.

There are negative implications to the House Registration bill which hopefully will not have to be explored. Among them is the possibility that the language is drafted so broadly that even electricians would need to register with the FDA if they do electrical work for medical devices.

Given the potential change in equilibrium, we are hopeful that the House User Fee Package will exclude ISO registration provisions. In this time of rising health care costs and emphasis on smart regulation, a provision of this type could cause hospitals to face increased costs without an appreciable patient safety benefit.

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