FDA designates resorbable implants for ACL injuries as class II
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The FDA announced it has classified resorbable implants for ACL injuries as class II, which provides a reasonable assurance of safety and effectiveness and will enhance patients’ access to beneficial innovation, the agency said.
Devices are classified into class II if general controls alone are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that provide reasonable assurance of the safety and effectiveness of the device for its intended use in combination with the general controls, according to the FDA. In addition to the general controls, the FDA determined that the establishment of special controls will provide reasonable assurance of the safety and effectiveness of resorbable implants for ACL repair.
Identified as a degradable material that allows for healing of a torn ACL that is biomechanically stabilized by traditional suturing procedures, resorbable implants for ACL repair are intended to protect the biological healing process from the surrounding intra-articular environment and are not intended to replace biomechanical fixation via suturing, according to the FDA. The FDA added this classification includes devices that bridge or surround the torn ends of a ruptured ACL.
In addition to general controls, the special controls for resorbable implants for ACL repair include the following:
- Clinical performance testing that demonstrates that the device performs as intended under anticipated conditions of use and includes postoperative evaluation of knee pain and function and durability as assessed by retear or reoperation rate.
- Animal performance testing that demonstrates that the device performs as intended under anticipated conditions of use and includes device performance characteristics, including resorption and ligament healing at repair site, and adverse effects as assessed by gross necropsy and histopathology.
- Nonclinical testing that demonstrates that the device performs as intended under anticipated conditions of use. Nonclinical testing must also include characterization of materials, including chemical composition, resorption profile and mechanical properties, and simulated use testing, including device preparation, device handling, compatibility with other ACL repair instrumentation and user interface.
- The device must be demonstrated to be biocompatible.
- Performance data must demonstrate the device to be sterile and nonpyrogenic.
- Performance data must support the shelf life of the device by demonstrating continued sterility, packing integrity and device functionality during the identified shelf life.
- Labeling must include identification of device materials and specifications; a summary of the clinical performance testing conducted with the device; instructions for use, including compatibility with other ACL repair instrumentation or devices; warnings regarding postoperative rehabilitation requirements; and a shelf life.
Resorbable implants for ACL repair are subject to premarket notification requirements under section 510(k) of the Federal Food, Drug, and Cosmetic Act.
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