Capture.JPGFarewell Commissioner Gottlieb

Sincere gratitude for your leadership and exemplary work during your current FDA tenure. You have been an inspiration.Capture.JPGEXIT INTERVIEW


New steps to broaden patient participation in cancer clinical trials

FDA issued new recommendations for broadening cancer trial eligibility criteria

  • More representative of patient population
  • Maximize the generalizability of the trial results
  • Maximize understanding of therapy’s benefit-risk profile across the patient population likely to receive the drug in clinical practice

Broadening eligibility criteria to include:  Pediatric patients, Patients with HIV, Hepatitis B and Hepatitis C Virus infections, Patients with brain metastases, organ dysfunction and prior or concurrent malignancies

New Guidances



Reorganization of CDRH

CDRH reorganization to implement efficiencies to integrate CDRH’s premarket and postmarket program functions

  • Reviewers, compliance officers and other experts would work in teams responsible for device oversight throughout the product’s development and commercialization
  • More integrated approach to device safety throughout the Total Product Life Cycle (TPLC) – already in pilot testing
  • Timeline: March 18, 2019 (begin) – September 30, 2019 (full implementation)

New Offices 

  • Office of Product Evaluation and Quality (OPEQ) :  Combines Office of Compliance, Office of Device Evaluation, Office of Surveillance and Biometrics, and  Office of In Vitro Diagnostics
  • Office of Policy – Two teams, the Guidance, Legislation and Special Projects Team and the Regulatory Documents and Special Projects Team
  • Office of Strategic Partnerships and Technological Innovation – Combines Science & Strategic Partnerships, Digital Health, Health Informatics and Innovation teams



“Request to Connect” – A New Way for Patients to Connect with FDA

“Request to Connect” portal is live
  • Gives patients and caregivers a single entry point to the Agency for questions and meeting requests
  • Co-developed by Patient Affairs Staff and the medical product centers
  • Will route inquiries to appropriate medical product center or office for responses in effective and efficient manner
  • Opportunity for FDA to better understand patient perspective and advance science of patient input

Implanted Brain-Computer Interface (BCI) Devices for Patients with
Paralysis or Amputation – Non-clinical Testing and Clinical

Implanted BCI devices increase ability to interact with environment and provide independence to patients with paralysis or amputation

  • Interface with nervous system to restore motor and/or sensory capabilities
  • Recommendations for non-clinical testing and study design considerations for IDE feasibility and pivotal clinical studies

Non-Clinical Bench Testing Considerations: Risk analysis, Electrodes, Leads and Connectors, Implanted casing and electronics, Output simulation measurements, Output simulation safety, Programmers/control unit, Radiofrequency transmitter and receiver, System level testing, factors for determining and design of animal studies

Clinical Study Considerations: Patient population, Home-Use, Duration and follow-up schedule, Inclusion/Exclusion criteria, Demographics, Treatment parameters, Endpoints including patient input (patient engagement. patient preference information, patient reported outcome measures)



SAFE USE ALERTS: Surgical Staplers and Staples, Contact Lenses

Surgical Staplers and Staples:

  • Increased number of adverse events reported to the FDA since 2011: 366 deaths, > 9,000 serious injuries, > 32,000 malfunctions
  • FDA Actions:
    • Letter to Healthcare Providers
    • Issue draft guidance on recommendations to manufacturers
    • Hold public meeting of  General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee  to reclassify as Class II (from Class I)
    • Require premarket notification and establish mandatory special controls to help mitigate known risks 

Contact lenses 

  • Risk of several serious conditions including eye infections and corneal ulcers
  • Can develop very quickly, be serious and can cause blindness
  • Video on safe and effective use

Image credits: FDA