Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff

Description

This guidance provides performance criteria for Orthopedic Fracture Fixation Plates in support of theSafety and Performance Based Pathway. Under this framework, submitters (you) planning to submit a 510(k) using the Safety and Performance Based Pathway for Orthopedic Fracture Fixation Plates will have the option to use the performance criteria proposed in this guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.

Scope & Applicability

Regulatory Context

• 21CFR888.3030§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

  (a) Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that arRead full regulation →

• 21CFR888.3040§ 888.3040 Smooth or threaded metallic bone fixation fastener.

  (a) Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straiRead full regulation →

• 21CFR10.115§ 10.115 Good guidance practices.

  (a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →

• Reviewers Guidance Checklist For Orthopedic External Fixation Devices Version #5 (Status: Final)
• Bone Anchors - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
• Orthopedic Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
• Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
• Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" : Guidance for Industry and Food and Drug Administration Staff (Status: Final)
• CPG Sec. 460.100 Hospital Pharmacies - Status as Drug Manufacturer (Status: Final)
• CPG Sec. 442.100 New Drugs - Export (Status: Final)
• CPG Sec. 400.325 Candy "Pills" Representation as Drug (Status: Final)