FDA News and Views: Patient Engagement in Clinical Trials, PEAC Summary, Real-World Evidence, Device Manufacturing in Puerto Rico – Drug and Device Digest

FDA BRIEF: Week of October 16, 2017


Clinical Trials & Medical Devices

Safe & effective medical device use increasingly depends on effective patient engagement

  • More involved in shared decision-making and disease management
  • Increasingly use devices at home
  • Communicate and connect to share information with other “real-world patients”

2016-2017 CDRH Strategic Priority: Partner with patients

  • Promote a culture of meaningful patient engagement by facilitating CDRH interaction with patients
  • Increase use and transparency of patient input as evidence in our decision-making

Culture of Patient Engagement



Patient Engagement Advisory Committee (PEAC) Summary

The FDA Patient Engagement Advisory Committeemet on October 11-12, 2017

  • To discuss patient input into medical device clinical trials
  • Discussions included topics such as patient involvement in clinical trial design; patient recruitment, enrollment and retention; communication of study results to trial participants

The future topics

  • Postmarket processes for medical devices
  • Data privacy and cybersecurity
  • Patient Reported Outcomes
  • Digital health and mental health

meeting materials



Real-World Data (RWD) : Data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources

Real-World Evidence (RWE) : Clinical evidence regarding the usage and potential
benefits or risks of a medical product derived from analysis of RWD

FDA Final RWE Guidance describes:

  • Generation and collection of RWD
  • Analysis of RWD
  • When results might be considered valid scientific evidence
  • Data Quality – Relevance and Reliability


Hurricanes Irma and JoseStatement by FDA Commissioner Scott Gottlieb, M.D. on medical device manufacturing recovery in Puerto Rico

More than 50 medical device manufacturing plants in Puerto Rico, employing about 18,000 people.

  • Manufacture more than 1,000 different kinds of medical devices
  • Simple but essential products like surgical instruments and dental products as well as highly complex devices such as cardiac pacemakers and insulin pumps

FDA monitoring 50 types of medical devices critically important to patient care

  • Working closely with manufacturers to prevent product shortages
  • Addressing  obstacles specific to unique product production requirements
  • Addressing challenges in securing components critical to device development.
  • Focus on blood-related medical devices


Image credits: FDA


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