An in-depth look at the FDA’s refurb docket

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 clarity on how these activities are defined, and what are some key considerations on the benefits and risks associated with these activities,” Deborah Kotz, press officer of media affairs and external affairs for the FDA

Read more here.

GE asks third-parties to stop selling CT and MR with sub-licensed software on them

GE Healthcare wants brokers and re-sellers of its medical equipment to be aware that not all the software on its CT or MR systems can necessarily be bundled into the sale of the equipment itself.

Read more here.

FDA announces public workshop to discuss third-party refurb docket

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 12th Annual IAMERS European Meeting

The 12th Annual European Meeting is coming up soon on 14–16 September in Lisbon, PT.
The meeting will begin on Wednesday night (14 September) with a reception and dinner. Business sessions will be held on Thursday and a partial day Friday. There will be a reception and dinner in a local restaurant on Thursday night.

 Keynote address on Thursday morning – Joe Shrawder, GE
 Changes in ISO 13485 for 2016 and it’s similarities to FDA requirements
 Review of current technologies
 Review of IAMERS Best Practices
 Importation of equipment into the US
 VAT requirements for Europe
 And more

Come early and join the private IAMERS tours in and near Lisbon. Tuesday’s tour will go to Sintra – a UNESCO World Heritage Site that was the summer palace of kings. For paying spouses, there will be an additional tour of Lisbon on Thursday.

We suggest you come early or stay late, as there is plenty to see and do in Lisbon.

Tivoli Lisboa @ Avenida da Liberdade 185.
Reservations for rooms should be made through IAMERS.
Rates are €180 for singles and €192 for doubles, which includes breakfast.

We would like to accommodate as many at the hotel as possible. However, we have a limited number of rooms and our room block expires on 1 August.

If you are planning to attend the meeting and would like us to save you a room, please contact us as soon as possible, with your check-in/out dates and type of room (single or double). We will also need credit card information for the guarantee.

If you have already told us of your room needs, including credit card information, please do not respond to this email. We have you in the queue.

Please click here for the registration form for the meeting as well as the tours. Early registration ends on July 31st.

If you have any questions please contact me by phone or email.

+1.201.357.5400 (office)
+1.201.415.6807 (mobile)

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