FDA Brief: Week of Feb  8, 2016

fda guidances


 

nonallergy

 

  • Developing drug products for the treatment of nonallergic rhinitis (NAR) in children and adults
  • Definition of a clinical phenotype, trial design, efficacy, and safety
  • Development programs for the treatment of vasomotor rhinitis, a subtype of NAR

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allergy

  • Developing drug products for treatment of seasonal allergic rhinitis (SAR) in children and adult
  • Trial design, effectiveness, and safety for SAR and perennial allergic rhinitis (PAR)
  • Based on assessment of :
    • Prior allergic rhinitis clinical trials
    • Agency’s current understanding of SAR and PAR mechanisms, pathophysiology

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display devices

  • Based on current technologies – to assist premarket notification submissions for display devices intended for use in diagnostic radiology
  • Class II devices intended  for controlled viewing conditions to display and view digital images for primary image interpretation
  • Application should include:
    • Device description & Indications for Use
    • Electrical Safety
    • Firmware and Software Documentation
    • Physical Laboratory Testing
    • Labeling

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ortho

  • Orthopedic devices using ultrahigh molecular weight polyethylene (UHMWPE) – Conventional, Highly crosslinked, Vit E highly crosslinked, Non-conventional
  • Determining appropriate information and testing for 510(k), de novo requests, PMA, HDE and IDE
  • Characterization of material (e.g.material description, sterility, biocompatibility, mechanical properties, and chemical properties), Biocompatibility and Shelf life

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