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
- CDRH Patient Organization Awareness Day
- Patient Engagement Advisory Committee
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
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
Statement 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