Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation – Guidance for Industry and Food and Drug Administration Staff

Guidelines Tuesday, February 26th, 2013

U.S. Food and Drug Administration: February 15, 2013

Public Comment

You may submit written comments and suggestions at any time for Agency consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, (HFA-305), Rockville, MD, 20852. Submit electronic comments to http://www.regulations.gov. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register. Comments may not be acted upon by the Agency until the document is next revised or updated.

Additional Copies

Additional copies are available from the Internet. You may also send an e-mail request to dsmica@fda.hhs.govto 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 1708 to identify the guidance you are requesting. Read more

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