title: Orthopedic implant approval: achieving the right balance.
authors: Michael G
authors: MG
authors: Zywiel
authors: Michael A
authors: MA
authors: Mont
mesh_terms: D002986:Clinical Trials as Topic; D018795:Device Approval; D006801:Humans; D009985:Orthopedics / Q000191:economics; D019736:Prostheses and Implants / Q000009:adverse effects / Q000191:economics; D014481:United States; D014486:United States Food and Drug Administration