title: Demystifying the U.S. Food and Drug Administration: understanding regulatory pathways.
abstract: BACKGROUND
  The field of plastic surgery has been at the forefront of ideation and innovation. Surgeon scientists today continue to develop novel products that fulfill the needs of the medical community and patients. Part of this process requires the approval from various regulatory agencies and offices, including the U.S. Food and Drug Administration. Unfortunately, medical training does not include regulatory knowledge, and many surgeon scientists find the regulatory pathway and U.S. Food and Drug Administration perplexing, overly complicated, and insurmountable. The authors aim to clearly outline the path of the regulatory process as it pertains to the U.S. Food and Drug Administration and its various jurisdictions that may relate to the plastic surgeon.
  
  
  METHODS
  The authors aim to demystify the classification system, 510(k), and Premarket Approval processes for devices; clarify the Investigational New Drug and New Drug Application requirements for drugs; and explain how human cells, tissues, and cellular or tissue-based products are classified and approvals obtained.
  
  
  RESULTS
  The structure of the U.S. Food and Drug Administration, its offices, and their roles are delineated, and the complex process of obtaining approval to market devices, drugs, biologics, and combination products is explained in a manner that is broadly useful to innovators whether new or experienced.
  
  
  CONCLUSIONS
  The authors provide information for innovators and inventors developing promising technologies to be more knowledgeable and motivated to embrace the process in a fashion that will potentially save time and errors in U.S. Food and Drug Administration submissions.
authors.forename: Nima
authors.initials: N
authors.lastname: Naghshineh
authors.forename: Spencer
authors.initials: S
authors.lastname: Brown
authors.forename: Paul S
authors.initials: PS
authors.lastname: Cederna
authors.forename: Benjamin
authors.initials: B
authors.lastname: Levi
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Lisiecki
authors.forename: Richard A
authors.initials: RA
authors.lastname: D'Amico
authors.forename: Keith M
authors.initials: KM
authors.lastname: Hume
authors.forename: William
authors.initials: W
authors.lastname: Seward
authors.forename: J Peter
authors.initials: JP
authors.lastname: Rubin
mesh_terms: D001688:Biological Products; D018795:Device Approval / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000331:legislation & jurisprudence* / Q000379:methods / Q000458:organization & administration; D006801:Humans; D013518:Surgery, Plastic; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence* / Q000458:organization & administration
chemical_list: D001688:Biological Products