The guidance provides rules for classification of devices and decision trees to guide those choices. Structural recommendations include using a four-tier system ranging from class A (lowest-hazard devices) to class D (highest-hazard devices); basing classification determinations on a device’s potential to harm a patient, its intended use and the technology it uses; accommodating future technological developments in the classification rules and requiring manufacturers to document their justifications.
Related Articles on Medical Devices:
10 Recent FDA Drug and Medical Device Decisions
Legislators Petition FDA for Faster, Simpler Medical Device Review Process
FDA Issues Two Draft Guidances on Medical Device Development, Studies
At the Becker's 23rd Annual Spine, Orthopedic and Pain Management-Driven ASC + The Future of Spine Conference, taking place June 11-13 in Chicago, spine surgeons, orthopedic leaders and ASC executives will come together to explore minimally invasive techniques, ASC growth strategies and innovations shaping the future of outpatient spine care. Apply for complimentary registration now.
