PPT-Progress in Providing Guidance for the Industry - AAMI, ASTM, and Others

John A Williams Medtronic John A Williams Medtronic 2 September 17 2020 Agenda Role of Standards AAMI Overview ASTM Overview Standards Alignment Other Forums Call to Action Continuing the Conversation. 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be submitted within 60 days of publication in the Federal Register of the not ice announcing the availa bility of the draft guidance Submit electronic comments to httpwwwregulationsgov S Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit written comments to the Di vision of Dockets Mana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be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments on the draft guidance to http Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments to httpwwwregulationsgov Sub Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit comments to the Division of Dockets Management HF Com ents and suggestio ns regar ing this draft do cu ent should be sub itted wit in 9 0 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Subm it comments to the D ivision of Dockets Manage e S Department of Health and Human Services Food and Drug Administration Ce nter for Drug Evaluation and Research CDER Cente for Biologics Evaluation and Research CBER December 2014 Electronic Submissions brPage 2br Providing Regulatory Submissions in D ALL WTFT OD WALL WTFT SQUARES 26 065 384 049 467 065 605 083 753 120 1028 049 634 058 743 065 827 072 909 083 1035 095 1169 109 1320 120 1436 035 519 049 717 065 937 109 1506 120 1640 049 800 065 1047 072 1182 083 1317 109 1691 120 1844 135 1889 1 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 &#x/MCI; 0 ;&#x/MCI; 0 ;Guidance for Industry &#x/MCI; 1 ;&#x/MCI; 1 ;Providing Regulatory Submissions in Electronic Format — Conten Flyte Flyte and T4/T5 togas and hoods are components of Stryker’s personal protection system and are intended to protect the patient, healthcare personnel and operating room personnel against con 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