FDA Releases Final Ruling on UDI

The U.S. Food and Drug Administration announced a final ruling today on the unique device identification system (UDI).

Read about it here.

With ‘Helium Cliff’ Dodged, More Challenging Discussions Await

On September 19th, the U.S. Senate passed an amended version of the Responsible Helium Administration and Stewardship Act, or HR 527, which was approved by the House of Representatives earlier this year. It still needs to be officially signed into law, but this is a major step to averting a helium shortage that had been looming for months.

Read about it here.

Broad Coalition Calls for Urgent Approval of Legislation to Safeguard Domestic Helium Supply

The Medical Imaging & Technology Alliance (MITA) and the Semiconductor Industry Association (SIA) today led a broad coalition of technology, medical, business and education leaders – including the National Electrical Manufacturers Association (NEMA) – in delivering a letter to Congress calling for urgent approval of legislation that will secure the nation’s helium supply.

Read about it here.

 

Friday Meeting Schedule

9:45 am
Unique Device Identification – A Panel Discussion
– Implementation
– IMDRF [1] & FDA

Moderator
Wayne Webster, Proactics Consulting

Panel Members
Robert Kerwin, Esq. IAMERS General Counsel
Mike Schmit Director, Remanufacturing Technology, General Electric

11:00 am
Hiren Desai, Partner, Soma Technology, Inc.
Hiren Vepari, Partner, Vepari & Co.
Emerging Markets – India: Prospects and Legalities

11:45 am
Shipping into the US
Part 2 – Regulations
– Accession Numbers
– FDA – Predict Program

12:00 pm
IAMERS Business Meeting

12:30 pm
Lunch, paid spouses welcome

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