If you have ever known anybody in need of a neurological device to address an illness, you will appreciate the importance of this guidance document. Sadly, one of my dearest friends was born with such a chronic condition and has periodically required implantation/re-implantation of such a device. The suffering endured while awaiting approval of new technology is heartbreaking, from the perspective of a supportive bystander. The uncertainty about which device(s) will be available and/or covered by existing insurance when needed just seems to add insult to injury. This is a fundamental quality of life area for concern.
The FDA’s new guidance for industry on Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes is intended to offer potential new options for developers of technology to enhance patient outcomes. The new guidance, issued November 7th, 2016, “recognizes the value of medical device innovation to address unmet clinical needs and improve patient care, particularly, when novel treatments may revolutionize how neurological diseases or conditions are treated.”
With an eye toward “clinically meaningful patient centered outcomes”, the 11-page document emphasizes promotion of this innovative sector of technology whereby devices intended to slow, stop, or reverse the effects of neurological disease are encouraged to apply for Investigational Device Exemptions and, thereby, be more readily available to those who would benefit from them.
For free download of this important new guidance document, visit the FDA website at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM489111.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery .
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