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[其他] 软件验证的基本原理;企业和FDA人员的最终指导准则

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最佳新人活跃会员热心会员灌水之王

发表于 2019-7-10 00:15:40 | 显示全部楼层 |阅读模式
Public Comment 公众评论(意见/问题)3 p' M; B# |2 O6 ^# i
Comments and suggestions may be submitted at any time for Agency consideration to Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. When submitting comments, please refer to the exact title of this guidance document. Comments may not be acted upon by the Agency until the document is next revised or updated.
) O2 x0 {# G& b* v( ]For questions regarding the use or interpretation of this guidance which involve the Center for Devices and Radiological Health (CDRH), contact John F. Murray at (301) 594-4659 or email jfm@cdrh.fda.gov  h1 C6 ]$ H! Y7 U
For questions regarding the use or interpretation of this guidance which involve the Center for Biologics Evaluation and Research (CBER) contact Jerome Davis at (301) 827-6220 or email davis@cber.fda.gov. (略)
: [+ L( G' Q3 H( K, U5 bAdditional Copies 额外话题9 w- K% J* R; h9 X- X: l) a
CDRH Additional copies are available from the Internet at: www.fda.gov/MedicalDevices/Devic ... ents/UCM085281.htm. You may also send an e-mail request to dsmica@fda.hhs.gov to receive an electronic copy of the guidance or send a fax request to 301-847-8149 to receive a hard copy. Please use the document number (938) to identify the guidance you are requesting.
3 _* p" ]1 v6 LCBER Additional copies are available from the Internet at: http://www.fda.gov/cber/guidelines.htm, bywriting to CBER, Office of Communication, Training, and Manufacturers' Assistance (HFM40), 1401 Rockville Pike, Rockville, Maryland 20852-1448, or by telephone request at 1800-835-5709 or 301-827-1800. (略): o  J+ }1 q, b/ ^" B. N$ K' u9 V
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