PDF-Guidance Document forDura Substitute Devices; Guidancefor IndustryDocu

PrefacePublic CommentComments and suggestions may be submitted at any time for Agency consideration toDockets Management Branch Division of Management Systems and Policy Office ofHuman Resources and. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the not ice announcing the availa bility of the draft guidance Submit electronic comments to httpwwwregulationsgov S Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments to httpwwwregulationsgov Sub Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit written comments to the Di vision of Dockets Mana 5741157455574535745357445574545746057459573765744157454574445737657459574615744757447574455745957460574495745557454574595737657458574455744757441574585744457449574545744757376574605744857449574595737657444574585744157446574605737657444 Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments on the draft guidance to http The draft of this document was issued on December 13 2012 For questions about this document regarding CDRHregulated devices contact Mary Brady at 3017966089 or by email at marybradyfdahhsgov or contact the Office of the Center Director at 30179659 Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit comments to the Division of Dockets Management HF 3 1 Research ethics committee approval3 2 Grounds for objection 4 3 Labelling of medical devices This guidance document has been revised to clarify our position on the use of clove oil as an anesthetic for fish This level 2 guidance document provides info rmation regarding the use of clove oil and its components as an anesthetic for fish Commen Comments and suggestions regarding this draft docu ment should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit comments to the Division of Dockets Management H (DCR-VSWCB-025) (01/10) This guidance document specifies the procedures rginia Soil and Water Conservation Board in determining the adequacy of a dam break inundation zone analysis and map prepared in Time and effort. ED granted flexibility in time and effort reporting. The Department of Education (ED) has taken steps in an attempt to reduce the burden of time and effort reporting as required under Office of Management and Budget (OMB) Circular . Time and effort. ED granted flexibility in time and effort reporting. The Department of Education (ED) has taken steps in an attempt to reduce the burden of time and effort reporting as required under Office of Management and Budget (OMB) Circular . and FDA Staff Class II Special Controls Guidance Document Surgical Sutures Guidance for Industry and FDA Document issued on June 3 2003 This document supersedes 147Class II Special Controls Guidance