Questions? Contact FDA/CDRH/OCE/DID at CDRH … · Records processed under FOIA # 2014-2621;...

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015 Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Transcript of Questions? Contact FDA/CDRH/OCE/DID at CDRH … · Records processed under FOIA # 2014-2621;...

Page 1: Questions? Contact FDA/CDRH/OCE/DID at CDRH … · Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015 Questions? Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@FDA.HHS.GOV

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 2: Questions? Contact FDA/CDRH/OCE/DID at CDRH … · Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015 Questions? Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@FDA.HHS.GOV

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 6: Questions? Contact FDA/CDRH/OCE/DID at CDRH … · Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015 Questions? Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@FDA.HHS.GOV

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 29: Questions? Contact FDA/CDRH/OCE/DID at CDRH … · Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015 Questions? Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@FDA.HHS.GOV

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Pages 30 through 33 redacted for the following reasons:- - - - - - - - - - - - - - - - - - - - - - - - - - - -(b) (4), (b) (4)(b) (4)-Sub-contractor material testing data

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 31: Questions? Contact FDA/CDRH/OCE/DID at CDRH … · Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015 Questions? Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@FDA.HHS.GOV

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Pages 37 through 38 redacted for the following reasons:- - - - - - - - - - - - - - - - - - - - - - - - - - - -(b) (4), (b) (4)- testing

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Pages 44 through 46 redacted for the following reasons:- - - - - - - - - - - - - - - - - - - - - - - - - - - -(b) (4), (b) (4)- material testing data

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 41: Questions? Contact FDA/CDRH/OCE/DID at CDRH … · Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015 Questions? Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@FDA.HHS.GOV

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Pages 55 through 56 redacted for the following reasons:- - - - - - - - - - - - - - - - - - - - - - - - - - - -(b) (4), (b) (4)-l testing data

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Pages 58 through 65 redacted for the following reasons:- - - - - - - - - - - - - - - - - - - - - - - - - - - -(b) (4), (b) (4)-l testing data

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Pages 97 through 114 redacted for the following reasons:- - - - - - - - - - - - - - - - - - - - - - - - - - - -(b) (4), (b) (4)-Engineering Drawings

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Welcome to today's FDA/CDRH Webinar · 1 Welcome to today’s FDA/CDRH Webinar Thank you for your patience while we register all of today’s participants. If you have not connected

Welcome to today's FDA/CDRH Webinar · 1 Welcome to today’s FDA/CDRH Webinar Thank you for your patience while we register all of today’s participants. If you have not connected

Questions?Contact Records processed FDA/CDRH/OCE/DID under ... · bath is heated with both heaters or, 1500 watts of heat. The water temperature will increase at a rate of approximately

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Welcome to the WCBP CMC Strategy Forum · 2018-04-02 · Douglass Mead, Janssen R & D, LLC Jaqueline Ryan, CDRH, FDA Lana Shiu, CDRH, FDA Nancy Waites, CBER, FDA 15:45 – 16:30 Recap

Welcome to the WCBP CMC Strategy Forum · 2018-04-02 · Douglass Mead, Janssen R & D, LLC Jaqueline Ryan, CDRH, FDA Lana Shiu, CDRH, FDA Nancy Waites, CBER, FDA 15:45 – 16:30 Recap

Records Processed under FOI request 2017-5744 & 2017-9103 ... · Records Processed under FOI request 2017-5744 & 2017-9103; Released by CDRH on 04/12/2018 Questions Contact FDA/CDRH/DID

Records Processed under FOI request 2017-5744 & 2017-9103 ... · Records Processed under FOI request 2017-5744 & 2017-9103; Released by CDRH on 04/12/2018 Questions Contact FDA/CDRH/DID

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1 Overview of Standards for External Defibrillators: Role of FDA Charles Ho, Ph.D. FDA/CDRH/ODE Charles.ho@fda.hhs.gov.

1 Overview of Standards for External Defibrillators: Role of FDA Charles Ho, Ph.D. FDA/CDRH/ODE [email protected].

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