Regulatory Affairs

FDA considering a radiation sterilization change master file pilot program

On June 7, 2022, the FDA announced it was considering a master file pilot program for premarket approval (PMA) holders whose approved devices are sterilized using radiation, including gamma radiation. The FDA is considering this pilot program due to global supply chain constraints and to...

The iia is pleased to welcome Institute de Radioprotection et de Sûreté Nucléaire (IRSN) France as its latest new member.  IRSN contributes to the safety of existing and future nuclear facilities, and to the radiological monitoring of French national territory and of workers exposed to...

The Government of Ontario in partnership with the Canadian Nuclear Isotope Council, Organization of Canadian Nuclear Industries and McMaster University is organizing virtual trade missions to Europe and the United States focused on medical isotopes. The iia is a member of the Canadian Nuclear Isotope Council...

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The Organizing Committee of the 3rd Medical Device Sterilization Workshop is pleased to announce the next meeting for stakeholders exploring accelerator-based sterilization alternatives, “Medical Device Sterilization: Understanding the Possibilities.” This virtual meeting will take place in the mornings (CDT) on September 22, 23, & 24, 2021....

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The International Irradiation Association (iia) is seeking applications from those who would like to join a small team who are responsible for the development and implementation of Association initiatives. The iia represents a diverse international community of organisations involved in the science and use of ionising...

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The Transport Facilitation Working Group (TFWG), of which iia is a member, is running a short awareness programme aimed at IAEA Member States that are considering appointing a National Focal Point (NFP) for denials of shipments of radioactive material.  The role of the NFP is...

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The IAEA recently hosted a virtual workshop to promote the beneficial applications or irradiation technologies. The International Irradiation Association and a number of iia members were in attendance and presented at the meeting. An IAEA article about the event can be found via this link: IAEA...

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Steritech's new X-ray facility in Melbourne has received conditional approval to treat Australian table grapes and cherries destined for the Vietnamese market. For further details click on this link to an article in Asiafruit....

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Radiation processing can broadly be defined as the “intentional irradiation of products or materials to preserve, modify or improve their characteristics” (ASTM E3083). Applications include the irradiation of blood products, the treatment of foodstuffs, the sterilization of medical devices and the modification of polymers and...

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The Microbiology Working Group of the Panel on Gamma and Electron Irradiation has published a guide on Risk Assessment following Sterilisation Dose Audit failure, in accordance with ISO11137-2 section 10.4. The new document is available to download from the Guides area of the Panel website....

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Bovine pericardium or porcine tissue are increasingly used to make heart valves. These biological prostheses now tend to be preferred but they pose a problem of durability. Our member Fraunhofer FEP in Germany has developed a multi-component process called SULEEI for longer functional life of biological...

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Assurance of Sterility for Sensitive Combination Products and Materials: New Paradigms for the Next Generation of Medical Devices and Pharmaceuticals discusses the medical device industry and existing challenges regarding the exciting new world of sensitive combination products (SCPs) and their terminal sterilization. This book reassesses the...

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