MITA continues to omit in its proposed Servicing Standard device manufacturer responsibility to provide appropriate documentation for technical descriptions, instructions for use and preventive and corrective maintenance and repair procedures, despite ANSI/AAMI EQ56: 2013. IAMERS after receiving a copy of the latest version of MITA's servicing standard, notified MITA that the Standard continues to impose [...]
Independent servicers across the nation have registered with their congressional representatives strong disapproval to the proposed independent servicers legislation. Read more here.
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.
FDA Chief Scientist Dr. Maisel speaking at the New Orleans IAMERS Annual Meeting today BEST PRACTICES COMMITTEE of IAMERS speaking on Complaint Management
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.
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 [...]
The FDA announced it does not intend to enforce the requirement to use its unique device identifier system for labels on medical devices manufactured and labeled before Sept. 24, 2021. In final guidance issued Aug. 30, the agency said stakeholders had expressed concern that pharmacies and other entities in the supply chain were not prepared [...]
Why is this happening now? According to the docket itself, the FDA’s renewed interest in refurbishment came as a response to safety concerns brought to its attention. It’s also a chance to address ambiguities in the way certain terms associated with refurbishment and third-party service are defined. “We hope that this current effort provides additional [...]
Now that the commenting period has ended, the FDA plans to host a two-day public workshop for stakeholders to discuss the questions raised in its third-party service and refurbished medical device docket. Read more here.
The CMS has sent a sweeping finalized rule that will overhaul the managedMedicaid program to the Office of Management and Budget for review. The 653-page proposed version of the rule suggested the biggest changes in Medicaid managed-care regulations in more than a decade. It would cap insurer profits, require states to more rigorously supervise the [...]