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The US FDA releases draft guidelines for Medical Devices


On 19th May 2021 – the US FDA issued draft guidance with recommendations concerning clinical trials of devices purposed for treating diabetes.


According to a news release, the guidance includes recommendations for feasibility and early feasibility clinical studies of certain medical devices intended to therapeutically improve glycemic control in patients with type 2 diabetes mellitus, independent of medication delivery. In this list of devices, the guidance also includes neurostimulators and those that mimic or result in anatomical changes similar to those made by bariatric surgical procedures, alter the anatomy and/or physiology of the small intestines or manipulate the sympathetic nervous system.


Dr Jeff Shuren, the director of the FDA's Center for Devices and Radiological Health, said in the release that the prevalence of type 2 diabetes in the U.S. has resulted in a growing interest among medical device manufacturers and researchers to develop therapeutic devices designed to improve glycemic control.

Currently, there are no legally marketed medical devices in the U.S. that are intended to do so, Shuren said. At the same time, the diabetes community only has FDA-cleared and approved devices for measuring and monitoring blood glucose and dosing and delivering insulin.


"As part of our commitment to helping accelerate the development of innovative medical devices to improve patient care, the draft guidance issued today provides the FDA's initial thinking on feasibility and early feasibility clinical studies for certain medical devices intended to improve glycemic control," Shuren said. "With our focus on improving public health and making technologies available that can help improve the quality of life for those with chronic diseases like Type 2 diabetes, we're interested in getting feedback from manufacturers as well as the diabetes community on this draft guidance." (same as source)

Additionally, the US FDA published a guidance document for Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment.


This guidance document provides the US FDA’s recommendations on testing to assess the safety and compatibility of medical devices in the Magnetic Resonance (MR) Environment and the recommended format for Magnetic Resonance Imaging (MRI) Safety Information in medical device labelling.


Recently the European Union saw the rollout of new guidelines for the incoming Medical Device Regulation (MDR) on 26 May 2021.  Industry perceives these guidelines, laws and regulations as a restraint on innovation, especially where there is a mandatory requirement to up-classify some devices to a higher risk classification.  With the new MDR, we believe that circa 85% of the small to mid-sized medical device manufacturers now face challenges in managing regulatory requirements during design, development and manufacturing processes.


If you are ‘all at sea’ with the new MDR requirements or need support with your global regulatory strategy for your medical device, please feel free to connect with our experts!


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