title: Premarket assessment of devices for treatment of critical limb ischemia: the role of Objective Performance Criteria and Goals.
abstract: Medical devices are cleared for marketing approval through the Food and Drug Administration (FDA). Unique statutory requirements, such as the "least burdensome mandate," have allowed the FDA to employ non-concurrent controls in its evaluation of prospective therapies. The use of Objective Performance Criteria and Goals (OPC and OPG) for the premarket evaluation of cardiovascular devices has become established as an alternative to randomized, controlled trials (RCTs). These single-armed comparisons may facilitate rapid entry of novel devices to the market. Unlike RCTs, they do not establish superiority or non-inferiority of the examined therapy, and study populations must be carefully inspected to ensure validity of comparisons to historical controls.
authors.affiliation: Section of Vascular Surgery, Washington University School of Medicine, St Louis, Mo, USA. geraghtyp@wustl.edu
authors.forename: Patrick J
authors.initials: PJ
authors.lastname: Geraghty
authors.forename: Jon S
authors.initials: JS
authors.lastname: Matsumura
authors.forename: Michael S
authors.initials: MS
authors.lastname: Conte
mesh_terms: D026683:Advisory Committees; D002406:Catheterization, Peripheral / Q000009:adverse effects / Q000295:instrumentation*; D018849:Controlled Clinical Trials as Topic; D016638:Critical Illness; D018795:Device Approval; D004867:Equipment Design; D004869:Equipment Safety; D019317:Evidence-Based Medicine; D005121:Extremities / Q000098:blood supply*; D006801:Humans; D007511:Ischemia / Q000601:surgery / Q000628:therapy*; D017410:Practice Guidelines as Topic; D011358:Product Surveillance, Postmarketing; D012107:Research Design; D014481:United States; D014486:United States Food and Drug Administration; D014656:Vascular Surgical Procedures / Q000009:adverse effects / Q000295:instrumentation*