Equipment service stakeholders to meet with FDA after passage of MDUFA
August 04, 2017
By Robert J. Kerwin
General Counsel, IAMERS
Yesterday the Senate passed the Medical Device User Fee Act.
This bill is shortly to be presented to the president for signature, as it was passed overwhelmingly by the House of Representatives.
Of interest to servicers is the provision that provides issuance of a report by the FDA on the status of servicing of medical devices within 270 days of enactment.
“We look forward to continuing to work with the FDA on this and other challenges, and we are especially delighted that the FDA and various industry stakeholders are meeting next Tuesday, August 8 at Nationwide Imaging to discuss best practices and the challenges facing the industry," noted Diana Upton, IAMERS President.
That meeting will be hosted by Robert Manetta, Nationwide's senior vice president, and AAMI will be moderating the program.
"We are dedicated to patient safety and want to have a [full] exchange of information," added Upton.
General Counsel, IAMERS
Yesterday the Senate passed the Medical Device User Fee Act.
This bill is shortly to be presented to the president for signature, as it was passed overwhelmingly by the House of Representatives.
Of interest to servicers is the provision that provides issuance of a report by the FDA on the status of servicing of medical devices within 270 days of enactment.
“We look forward to continuing to work with the FDA on this and other challenges, and we are especially delighted that the FDA and various industry stakeholders are meeting next Tuesday, August 8 at Nationwide Imaging to discuss best practices and the challenges facing the industry," noted Diana Upton, IAMERS President.
That meeting will be hosted by Robert Manetta, Nationwide's senior vice president, and AAMI will be moderating the program.
"We are dedicated to patient safety and want to have a [full] exchange of information," added Upton.