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Notice. "Medical Devices: Neurological Devices; Electroconvulsive Therapy Device; Establishing a Public Docket" Federal Register 74, no. 174 (September 10, 2009): 46607-46608. https://www.govinfo.gov/app/details/FR-2009-09-10/E9-21807.
Office of the Federal Register, National Archives and Records Administration. (). 74 FR 46607 - Medical Devices: Neurological Devices; Electroconvulsive Therapy Device; Establishing a Public Docket. [Government]. Office of the Federal Register, National Archives and Records Administration. https://www.govinfo.gov/app/details/FR-2009-09-10/E9-21807
Office of the Federal Register, National Archives and Records Administration. 74 FR 46607 - Medical Devices: Neurological Devices; Electroconvulsive Therapy Device; Establishing a Public Docket. Office of the Federal Register, National Archives and Records Administration, , https://www.govinfo.gov/app/details/FR-2009-09-10/E9-21807
Office of the Federal Register, National Archives and Records Administration, Medical Devices: Neurological Devices; Electroconvulsive Therapy Device; Establishing a Public Docket, govinfo, (September 10, 2009), https://www.govinfo.gov/app/details/FR-2009-09-10/E9-21807.
Close xFederal Register Volume 74, Issue 174 (September 10, 2009)
Regulatory Information
Federal Register
AE 2.7:
GS 4.107:
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Office of the Federal Register, National Archives and Records Administration
Notices
Notice.
Submit written or electronic comments and information by January 8, 2010.
Victor Krauthamer, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., W066-1106, Silver Spring, MD 20993, 301-796-2474.
The Food and Drug Administration (FDA) is announcing the opening of a public docket to receive information and comments regarding the current classification process related to electroconvulsive therapy devices (ECT). The current classification process for this device pertains to the "Order for Certain Class III Devices; Submission of Safety and Effectiveness," published in the Federal Register of April 9, 2009 (74 FR 16214). Under the Order, FDA required manufacturers of certain Class III devices, including ECT, to submit a summary of, and citation to, any information known or otherwise available to them respecting such devices, including adverse safety or effectiveness information which has not been submitted under the Federal Food, Drug, and Cosmetic Act (the act). For each device subject to the Order, FDA is reviewing the submitted information to determine whether FDA should maintain the device as class III and require the submission of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP), or whether FDA should reclassify the device into class II or class I. FDA is now inviting interested persons to submit comments that relate to the safety and effectiveness of ECT.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
46607-46608
74 FR 46607
Docket No. FDA-2009-N-0392
E9-21807