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FDA Classification of Posterior Cervical Screw Systems Small Entity Compliance Guide

蒋千琴 12/4/2021 浏览 235 FDA U.S

标准简介

Classification of Posterior Cervical Screw Systems Small Entity Compliance Guide[附网盘链接]是Food&Drug Administration发布的FDA标准，适用于U.S。

标准截图

Classification of Posterior Cervical Screw Systems Small Entity Compliance Guide[附网盘链接]
Classification of Posterior Cervical Screw Systems Small Entity Compliance Guide[附网盘链接](截图)

 

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标准部分原文

Classification of Posterior Cervical Screw Systems: Small Entity Compliance Guide 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 On April 1, 2019, FDA published a final rule in the Federal Register entitled “Classification of Posterior Cervical Screw Systems” (84 FR 12088). This final rule created the classification regulation 21 CFR 888.3075 for posterior cervical screw systems and established special controls. FDA has prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121, as amended by Public Law 110-28) to assist small entities to comply with the requirements established in 21 CFR 888.3075. 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 guidance means that something is suggested or recommended, but not required. II. Background Prior to the classification, FDA regulated posterior cervical screw systems as unclassified preamendments devices requiring premarket notification (510(k)). On April 9, 2009, FDA published an order under sections 515(i) and 519 of the FD&C Act (515(i) order) for the submission of safety and effectiveness information on pedicle screw spinal systems with certain indications for use (74 FR 16214). In response to that order, FDA received a request from the Orthopedic Surgical Manufacturers Association (OSMA) to

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