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FDA Bone Anchors - Premarket Notification (510(k)) Submissions

蒋千琴 11/12/2021 浏览 266 FDA US

标准简介

Bone Anchors - Premarket Notification (510(k)) Submissions[附网盘链接]是Food And Drug Administration发布的FDA标准，适用于US。

标准截图

Bone Anchors - Premarket Notification (510(k)) Submissions[附网盘链接]
Bone Anchors - Premarket Notification (510(k)) Submissions[附网盘链接](截图)

 

标准文档说明

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标准部分原文

Bone Anchors - Premarket Notification (510(k)) Submissions Guidance for Industry and Food and Drug Administration Staff This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff or Office responsible for this guidance as listed on the title page. I. Introduction This guidance document provides recommendations for 510(k) submissions for bone anchor (suture anchor) devices. These devices are indicated for attachment of soft tissue to bone. This final guidance clarifies and provides current thinking on the recommended content for a bone anchor 510(k) submission, including performance testing recommendations and device description. Specifically, this guidance reflects the most current thinking on relevant bench testing methods for bone anchor devices including nitinol and absorbable polymeric bone anchors. For the current edition of the FDA-recognized standard(s) referenced in this document, see the 1

FDA Recognized Consensus Standards Database. For more information regarding use of consensus standards in regulatory submissions, please refer to the FDA guidance titled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical 2

Devices.”

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. 1

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. 2

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-

consensus-standards-premarket-submissions-medical-devices.

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