2016 CDER Guidances, CDRH Interoperable Devices, Neurological Devices Reclassification – Drug and Device Digest

FDA Brief: Week of Jan 25, 2016

fda guidances


New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2016


Advertising, Biopharmaceutics, Clinical/Antimicrobial,  Clinical/Medical, Clinical Pharmacology,  Clinical/Statistical,  Electronic Submissions,  Labeling, Pharmaceutical Quality/CMC,  Pharmaceutical Quality/Manufacturing Standards (CGMP), Pharmacology/Toxicology,  Procedural,


  • Health Care Economic Information in Promotional Labeling and Advertising
  • Treatment/Prevention of Anthrax, Attachment to HIV-1 Infection, Bacterial Vaginosis, Chronic Hepatitis C Virus Infection, Recurrent Herpes Labialis, Vulvovaginal Candidiasis, Allergic Rhinitis,  Exocrine Pancreatic Insufficiency,  Rare Diseases,  Nonallergic Rhinitis, Ulcerative Colitis
  • Patient Reported Outcomes for Varicose Vein burden, COPD
  • Adaptive Clinical Trial Design, Meta-Analysis for Safety
  • Post-marketing Safety reporting



Design Considerations and Pre-market Submission for Interoperable Medical Devices

  • Interconnectivity of  medical devices characterized as  “interoperability.”
  • Interoperability – Ability of two or more products, technologies or systems to exchange information and use of exchanged information
  • Highlights:
    •  designing systems
    •  performance testing and risk management activities
    • specifying functional, performance, and interface characteristics in labeling


Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator  (CES)

Intended To Treat Insomnia and/or Anxiety : Class III to II – 510(k)

Intended To Treat Depression : PMA

Recalssification based on deliberations of  2012 Panel meeting,  reclassification petitions  and  new information that there is sufficient information to establish special controls to mitigate risks.




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