Hot Topics Make CDRH Regulatory Science Priority List

Leverage “Big Data” for regulatory decision making—CDRH writes that big data brings a tremendous amount of valuable information to the issue of quality, safety, and effectiveness of medical devices and it is important to find ways to gather, store, and analyze the information for this application. One of MD+DI's finalists for 2015 Medtech Company of the Year is IBM Watson Health, the masters of big data. 

Leverage evidence from clinical experience and employ evidence synthesis across multiple domains in regulatory decision making—This is an effort to use data from additional sources besides manufacturers, such as real-world databases and publications, to inform regulatory decisions. 

Improve the quality and effectiveness of reprocessing reusable medical devices—It is important to find ways to ensure thorough, effective reprocessing measures, including device design, reprocessing instructions, validation methods, and surveillance. Learn more from MD+DI's coverage of contaminated reprocessed duodenoscopes. 

Develop computational modeling technologies to support regulatory decision making—There needs to be more significant use of computational modeling and simulations to make the regulatory process more efficient. 

Enhance performance of Digital Health and medical device cybersecurity—Improving the cybersecurity of connected medical devices is a growing concern, as evidenced by FDA communications, FBI alerts, and industry focus on the topic.

Incorporate human factors engineering principles into device design—CDRH writes that human factors engineering could have addressed the issues behind device adverse events and recalls. Here's a recent MD+DI piece on the importance of human factors studies. 

Modernize biocompatibility / biological risk evaluation of device materials—Standard biocompatibility tests could be improved by adding approaches that analyze and predict device biological risk factors, modeling, and chemical characterization. This could also reduce the need for animal testing. Read Qmed's coverage of two contrasting views on biocompatibility testing.

Advance methods to predict clinical performance of medical devices and their materials—There is a need for approaches and tools that help predict the clinical impact of new coatings, materials, and manufacturing methods to offer more insight on long-term safety and effectiveness. 

Advance the use of patient reported outcome measures (PROMs) in regulatory decision making—Regulators are emphasizing the importance of PROMs in device development and regulation, but the credibility and reliability of various PROMs is still in flux. CDRH wants to see trustworthy, relevant PROMs collected and validated. Read what one FDA official recently said on the importance of validated, clinically meaningful patient data. 

Collect and use patient experience/preference in regulatory decision making—Patient experience and preference is of growing importance, so CDRH wants to create approaches and tools to gather high quality patient experience information to impact regulatory decisions. Earlier this year, FDA released draft guidance on best practices for patient preference data.