FDA BRIEF: Week of August 8, 2016

fda guidances

bipolra

SCOPE:

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

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surgery.JPGSCOPE:

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

READ


 

 

2016.JPG

CATEGORIES

  • 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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