PDF-Guidance for Industry and Review Staff

Target Product Profile 151 A Strategic Development Process Tool DRAFT GUIDANCE This guidance document is being distributed for comment purposes only Comments and suggestions regarding this draf. 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be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments to httpwwwregulationsgov Sub Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit written comments to the Di vision of Dockets Mana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within 60 calendar days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit comments to the Division of Dockets Mana Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments on the draft guidance to http Comments and suggestions regarding this draft document should be submitted within 60 calendar days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit comments to the Division of Dockets Mana Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit comments to the Division of Dockets Management HF Com ents and suggestio ns regar ing this draft do cu ent should be sub itted wit in 9 0 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Subm it comments to the D ivision of Dockets Manage e This guidance document has been revised to clarify our position on the use of clove oil as an anesthetic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 US Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Office of In Vitro Diagnostic Device Evaluation and Safety Center for Biologic Evaluation and Research brPage 2br Contains NonBinding 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 4 9 DRAFT GUIDANCE ) or the Office of Communication, Outreach, and Development (CBER) at 8004709 or 240 27 U.S. Department of Health and Human ServicesFood and Drug Administration Center for Device Representative: First Last. Date: . February . 4. , 2015. Location: . Misc. . Conference Room. Management Review Agenda. Roll Call of Attendees (5.6.1). Suitability of Quality Policy (5.3e). Status of Quality Objectives (. 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