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.

Global medical imaging software market on track to exceed $4.7 billion by 2021

The global medical imaging software market is expected to reach more than $4.8 billion by 2021 at an annual growth rate of 7 percent, according to a new market report from Technavio.
Read more here.

IAMERS’ BEST Practices Committee To Present On Quality Management Systems At New Orleans Annual Meeting

The Best Practices Committee has issued recommended quality management templates for IAMERS members. The templates pertain to Complaint Management, Traceability, Training and Data Management. The Committee recommends IAMERS members engage in an internal review process to determine how the templates may be best used.

 

License Restrictions in the United States

We have been extensively examining the license restriction situation and have had a discussion on license restrictions with the Federal Trade Commission. We are at this time of the view that those who hold dominant positions in the diagnostic imaging market and seek to enforce license restrictions only when the relationship is not a strategic relationship, leave themselves open to the contention that their activities are not appropriate. We are continuing to look at the issue. If you have any information concerning this type of activity, please feel free to let us know.

 

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