title: US Food and Drug Administration medical device review and approval; myths, misconceptions, realities, and potential policy changes.
authors.affiliation: 21st Century Oncology, LLC, Fort Myers, Florida. Electronic address: paul.wallner@rtsx.com.
authors.forename: Paul E
authors.initials: PE
authors.lastname: Wallner
authors.affiliation: Department of Radiation Oncology, Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, California.
authors.forename: Howard M
authors.initials: HM
authors.lastname: Sandler
mesh_terms: D018795:Device Approval / Q000592:standards*; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration