Regulations & Guidances current as of :

(GCP-2) good clinical practice

GCP in FDA-Regulated Medical Device Clinical Trials

US code of federal regulations title 21: food and drugs
  • part 11—electronic records; electronic signatures
  • part 50—protection of human subjects
  • part 54—financial disclosure by clinical investigators
  • part 56—institutional review boards
  • part 801—labeling
  • part 803—medical device reporting
  • part 806—medical devices; reports of corrections and removals
  • part 807—establishment registration and device listing for manufacturers and importers of devices
  • part 812—investigational device exemptions
  • part 814—premarket approval of medical devices
  • part 820—quality system regulation
  • part 822—postmarket surveillance
  • part 830—unique device identification
additional FDA guidance documents
  • medical device reporting for manufacturers
ICH guidelines (as included in the us code for federal regulations)
  • Integrated Addendum to Good Clinical Practice