The USFDA Center for Devices and Radiological Health has recently issued three key final guidance documents focusing on orthopedic devices and sterilization practices. These guidances reflect the agency’s commitment to ensuring device safety, streamlining premarket submissions, and addressing public health concerns surrounding sterilization practices. Below, we provide an overview of these guidances and their significance.
Guidance: Orthopedic Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification (510(k)) Submissions
This guidance provides a structured framework for manufacturers submitting 510(k) premarket notifications for orthopedic non-spinal bone plates, screws, and washers. These devices, widely used in bone fracture repair and stabilization, require rigorous safety and efficacy evaluations.
Device Description: Manufacturers must include detailed descriptions, including design, dimensions, and intended use.
Performance Testing: Bench tests, fatigue testing, and biocompatibility assessments are necessary to demonstrate compliance with FDA standards.
Sterilization and Packaging: Submissions should include sterilization validation data and shelf-life testing to ensure the devices remain sterile and functional during use.
This guidance aims to create a consistent pathway for device manufacturers, ensuring safe and effective products reach the market.
This guidance provides performance criteria for non-spinal metallic bone screws and their associated washers in support of the Safety and Performance-Based Pathway As part of this framework, submitters intending to submit 510(k)s for non-spinal metallic bone screws and washers under the Safety and Performance Based Pathway can use this guidance's performance criteria to support substantial equivalence, rather than a direct comparison of the subject device to the predicate device.
Performance Benchmarks: Criteria include strength, fatigue resistance, and corrosion testing.
Material Requirements: Manufacturers must provide data on the composition and biocompatibility of metallic components.
Use of Standards: Devices that meet predefined performance standards can bypass certain direct comparison requirements, expediting market approval.
This pathway fosters innovation while ensuring safety and effectiveness, particularly for devices with well-established safety profiles.
Ethylene oxide (EtO) sterilization is critical for medical devices but has raised environmental and public health concerns due to its potential carcinogenic effects. This guidance establishes a transitional enforcement policy for Class III medical devices undergoing sterilization facility changes, balancing public health needs with regulatory compliance.
FDA believes that the policy outlined in this guidance may help prevent or mitigate the potential risk of supply chain disruptions or sterile medical device shortages by clarifying the regulatory landscape for devices sterilized by EtO and helping device manufacturers to quickly and proactively secure alternative locations for the EtO sterilization of devices.
For further details, explore the complete guidances here:
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