Summary of the FDA virtual public workshop on spinal device clinical review held on September 17, 2021.

Devlin, Vincent J; Jean, Ronald; Peat, Capt Raquel; Jiang, Hongying; Anderson, Paul A; Benson, John C; Brodke, Darrel S; Golish, S Raymond; Kebaish, Khaled M; Larson, A Noelle; Serhan, Hassan

Devlin, Vincent J; Jean, Ronald; Peat, Capt Raquel; Jiang, Hongying; Anderson, Paul A; Benson, John C; Brodke, Darrel S; Golish, S Raymond; Kebaish, Khaled M; Larson, A Noelle; Serhan, Hassan.

Afiliação

Devlin VJ; Office of Health Technology-6: Office of Orthopedic Devices, Office of Product Evaluation and Quality, CDRH | Food and Drug Administration, White Oak, Bldg 66, Rm 4450, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA. Electronic address: vincent.devlin@fda.hhs.gov.
Jean R; DHT6B: Division of Spinal Devices, OHT6: Office of Orthopedic Devices, Office of Product Evaluation and Quality, CDRH | Food and Drug Administration, White Oak, Bldg. 66, 10903 New Hampshire Avenue, Silver Spring, MD, USA.
Peat CR; OHT6: Office of Orthopedic Devices, Office of Product Evaluation and Quality, CDRH | Food and Drug Administration, White Oak, Bldg 66, Rm 4444, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
Jiang H; OHT6: Office of Orthopedic Devices, Office of Product Evaluation and Quality, CDRH | Food and Drug Administration, White Oak, Bldg 66, Rm 4444, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
Anderson PA; Department of Orthopedics and Rehabilitation, University of Wisconsin Hospital and Clinics, 600 Highland Ave, Madison, WI 53792, USA.
Benson JC; Department of Radiology, Mayo Clinic, 200 First St SW, Rochester, MN 55905, USA.
Brodke DS; Department of Orthopedics, Spencer Fox Eccles School of Medicine, University of Utah, University Orthopaedic Center, 590 Wakara Way, Salt Lake City, UT 84108, USA.
Golish SR; Jupiter Medical Center, Palm Beach, Florida 33458, USA.
Kebaish KM; Department of Orthopaedic Surgery, Johns Hopkins University, 601 North Caroline St Suite 5223, Baltimore, MD 21287-0882, USA.
Larson AN; Mayo Clinic, 200 1st St SW, Rochester, MN, USA.
Serhan H; Bioengineering Department, University of Toledo, 2801 W. Bancroft St, Toledo, OH 43606, USA.

Spine J ; 22(9): 1423-1433, 2022 09.

Article em En | MEDLINE | ID: mdl-35460900

Assuntos

Aprovação de Equipamentos; Humanos; Estados Unidos; United States Food and Drug Administration

Palavras-chave

Adverse events; Clinical outcome assessments; Clinical study endpoints; De Novo Classification request; Health disparities; Humanitarian device exemption; Investigational device exemption; Orthopedic devices; Premarket approval; Premarket notification; Secondary surgical procedures; Spinal devices; Spinal fusion; Study enrollment criteria

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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Aprovação de Equipamentos Tipo de estudo: Guideline / Prognostic_studies Limite: Humans País como assunto: America do norte Idioma: En Ano de publicação: 2022 Tipo de documento: Article

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