Regulatory

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

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

Read more here.

Senate FDA user fee package excludes ISO registration

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.

Read more here.

IAMERS Counsel Testifies Before Congress in Opposition to the Servicing Bill

Provided below is the link to the hearing held before the House Energy and Commerce Subcommittee on Health on 5/2/2017. The testimony of our general counsel Robert Kerwin and the questions placed by U.S. Congressional members to IAMERS and to MITA are important to our members.

To see more about the hearing. Click here.

New legislation would mandate all ISOs register with FDA

IAMERS Counsel Robert Kerwin to appear on May 2, 2017 before the U.S. House of Representatives Committee on Energy and Commerce on the Legislation.

On Tuesday, April 25, 2017, Congressman Ryan Costello (R-PA) and Congressman Scott Peters (D-CA) with the support of the Medical Imaging Technology Alliance, filed H.R. 2118 seeking to require registration of independent servicers of medical devices.

The Act — self-described as the “Medical Device Servicing Safety and Accountability Act” — would require the FDA, not later than 18 months after passage, to issue final regulations.

Read more details here.

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