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Minutes From Negotiation Meeting on MDUFA III Reauthorization, September 13, 2011
FDA – Industry MDUFA III Reauthorization Meeting September 13, 2011, 8:30 am – 1:00 pm FDA Switzer Building, Washington, DC Room 1007 Purpose To discuss MDUFA III reauthorization. Participants Meeting Start Time: 9:00 am Industry1 provided a response and counter-proposal to the proposal offered by the Agency on August 24, 2011. Industry reiterated that their…
Minutes from Stakeholder Meeting on MDUFA III Reauthorization, October 13, 2011
Stakeholder Meeting on MDUFA III Reauthorization October 13, 2011, 1:30 – 3:10 PM HHS Humphrey Building, Washington, DC Room 425A Purpose To provide a status update of the ongoing MDUFA III negotiations. Participants FDA Malcolm Bertoni Office of the Commissioner (OC) Ashley Boam Center for Devices and Radiological Health (CDRH) Nathan Brown Office of Chief…
Minutes From Negotiation Meeting on MDUFA III Reauthorization, October 26, 2011
FDA – Industry MDUFA III Reauthorization Meeting October 26, 2011, 10:30 – 12:15 pm FDA White Oak Building, Silver Spring, MD Room 2102 Purpose To discuss MDUFA III reauthorization. Participants FDA Malcolm Bertoni Office of the Commissioner (OC) Ashley Boam Center for Devices and Radiological Health (CDRH) Nathan Brown Office of Chief Counsel (OCC) Kate…
Class I Medical Device Recall: King International LLC., Shoulder<em>Flex </em>Deep-kneading Shiatsu Massager
Recall Class: Class I Date Recall Initiated: August 30, 2011 Product: ShoulderFlex Deep-kneading Shiatsu Massager, Model # SH61 This product was manufactured from June 1, 2003 through January 27, 2011 and distributed from October 18, 2003 through April 19, 2011. See related Safety Communication and Firm Press Release under Additional Links below. Use: The ShoulderFlex…
Meeting Announcement: February 10, 2012 Neurological Devices Panel of the Medical Devices Advisory Committee
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Virility Max: Recall
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SOP: Decision Authority for Additional or Changed Data Needs for Premarket Submissions
Version #1Effective Date: November 9, 2011 1. Purpose The purpose of this document is to define the appropriate decision level for making additions or changes in data requirements from what was requested for premarket submissions in previous communications. This SOP will provide criteria under which changes to recommendations for premarket data can stay at the…
Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff
DRAFT GUIDANCEThis guidance document is being distributed for comment purposes only.Document issued on: November 10, 2011 You should submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA-305),…
Draft Guidance for Industry and Food and Drug Administration Staff
DRAFT GUIDANCEThis guidance document is being distributed for comment purposes only.Document issued on: November 10, 2011 You should submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA-305),…