FDA Perspectives on the Regulation of Neuromodulation Devices

Author:

Marjenin TimothyORCID,Scott Pamela,Bajaj Anita,Bansal Tushar,Berne Bernard,Bowsher Kristen,Costello Ann,Doucet John,Franca Eric,Ghosh Chandramallika,Govindarajan Anupama,Gutowski Stacie,Gwinn Katrina,Hinckley Stephen,Keegan Erin,Lee Hyung,Mathews Binoy,Misra Sanjay,Patel Shyama,Tang Xiaorui,Heetderks William,Hoffmann Michael,Pena Carlos

Publisher

Elsevier BV

Subject

Anesthesiology and Pain Medicine,Neurology (clinical),Neurology,General Medicine

Reference13 articles.

1. Mission statement, center for devices and radiological health. https://www.fda.gov/about-fda/center-devices-and-radiological-health/cdrh-mission-vision-and-shared-values

2. Medical device classification system. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm

3. Neurological devices are outlined in 21 CFR 882. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=882); Physical Medicine devices are outlined in 21 CFR 890 (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=890).

4. CDRH Clinical trial enterprise targets and performance http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHVisionandMission/UCM463964.pdf

5. Medical device general and special controls http://www.fda.gov/medicaldevices/deviceregulationandguidance/overview/generalandspecialcontrols/ucm055910.htm

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