FDA BRIEF: Week of August 8, 2016

fda guidances



Bipolar electrosurgical vessel sealers are designed to seal isolated blood and lymphatic vessels for hemostasis (as an alternative to ties) through the use of high-frequency electrical current between two electrodes in close proximity.

CONTENT: 510(k) submissions for  intended for use in general surgery.

  • Device Description: Indications for Use, Device Design
  • Substantial Equivalence Comparison:  Indications for Use, Electrosurgical Unit (ESU), Active Components/Accessories, Miscellaneous Accessories, Vessels
  • Performance Data: ESU,  Active Components/Accessories,  Miscellaneous Components/Accessories, System Testing, Chronic Animal Study
  • Clinical Testing
  • Labeling:  Instructions for Use (User Manual), Device Labels, Package, Special Components



Electrosurgical devices intended for use in general surgery are designed to cut and/or remove tissue and control bleeding through the use of highfrequency electrical current. Devices may also be called radiofrequency (RF) devices or high-frequency (HF) devices.

GUIDANCE:  510(k) submissions for  intended for use in general surgery.

  • Device Description.: Indications for Use,  Device Design
  • Substantial Equivalence Comparison
  • Software
  • Biocompatibility
  • Sterility.
  • Reprocessing.
  • Pyrogenicity
  • Shelf Life
  • Performance Data: ESU, Active Components/Accessories, Neutral Electrodes,  Miscellaneous Components/Accessories System Testing
  • Electrical Safety and Electromagnetic Compatibility
  • Clinical Testing
  • Labeling






  • Advertising: e.g. Health Care Economic Information in Labeling and Advertising,  Internet/Social Media Advertising , Presenting Risk Information in Prescription Drugs and Medical Devices Promotion; Revised Draft
  • Biopharmaceutics: e.g. Bioavailabiolity/Bioequivalence studies, food effect
  • Biosimilarity:  e.g. Interchangeability, Labeling, Statistical Approaches
  • Clinical/Antimicrobial: e.g.  Inhalation Anthrax, HIV-1 Infection, Bacterial Vaginosis, Chronic Hepatitis C,  Herpes Labialis, Vulvovaginal Candidiasis
  • Clinical/Medical: e.g. Allergic Rhinitis, Exocrine Pancreatic Insufficiency,  Natural History Studies for Rare Disease,  Nonallergic Rhinitis, Pediatric Oncology , Pregnant Women in Clinical Trials,  Varicose Vein,  Ulcerative Colitis
  • Clinical Pharmacology: e.g. Drug Interactions,Lactation Trials,  In vitro Metabolism-and-Transporter Mediated,  Impaired Renal Function, Pregnancy and the Postpartum Period,  Population Pharmacokinetics
  • Labeling : e.g. Child Resistant Closures, Gluten, Hormonal Contraceptives
  • Pharmaceutical Quality/CMC: e.g. Immunogenicity Testing,  Comparability Protocols,  Elemental Impurities, Compendial Standards,  Abuse Deterrent Properties
  • Pharmaceutical Quality/Manufacturing Standards (CGMP)
  • Pharmacology/Toxicology
  • Procedural


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