Artificial Pancreas Guidance Allows For More Flexibility In Trial Design

FDA’s final guidance on the design and clinical study of artificial pancreas systems broadens the study endpoints permissible for the devices, which aim to “close the loop” in the treatment of type 1 diabetes.

FDA incorporated feedback from the diabetes community in a final guidance document on artificial pancreas systems to allow for more flexibility in the design of clinical trials of the devices.

The Nov. 9 document finalized what had been two distinct draft guidance documents – a December 2011 proposal on clinical...

More from Regulation

Commission Decision Launches Pediatric And Rare Disease Expert Group

 

A revised annex to the original decision also outlines expert remuneration limits and introduces further changes.

Dermal Fillers For Décolletage May Gain FDA Approval

 
• By 

An upcoming US FDA advisory panel meeting will discuss adding a new indication to allow dermal fillers to be used in the upper chest, or décolletage. Plastic surgeons expect this could drive interest in the procedure, which is already performed off-label.

Planning To Take Part in MDUFA? FDA Wants To Hear From You

 

The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.

Finland Cracks Down On Software That Needs Regulating As A Medical Devices

 

Finland has initiated a project to improve the effectiveness of the monitoring of software intended for medical use and to ensure that software placed on its market meets the requirements set for it. 

More from Policy & Regulation

Planning To Take Part in MDUFA? FDA Wants To Hear From You

 

The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.

Global Medtech Guidance Tracker: June 2025

 
• By 

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.

Finland Cracks Down On Software That Needs Regulating As A Medical Devices

 

Finland has initiated a project to improve the effectiveness of the monitoring of software intended for medical use and to ensure that software placed on its market meets the requirements set for it.