CDRH Outlines Regulatory Science Priorities for Upcoming Fiscal Year

Collecting and using patient preference data as part of the regulatory decision-making process and ensuring the proper reprocessing of reusable medical devices are two top challenges the FDA’s Center for Devices and Radiological Health hopes to tackle as part of its regulatory science priorities for fiscal year 2016.

Developed by a CDRH subcommittee, the list names regulatory science needs/gaps identified by center personnel. It includes 10 items of equal importance.

“The regulatory science priorities serve as a precept for making strategic intramural research funding decisions to ensure that CDRH research is focused on issues/gaps/needs that are relevant and critical to the regulatory science of medical devices and radiation-emitting products,” according to a report detailing the priorities.

Device reprocessing has taken center stage after complex duodenoscopes came under scrutiny in the wake of being linked to the transmission of antibiotic-resistant infections. To prevent future infections, CDRH recommends taking a comprehensive approach to addressing reprocessing techniques. Approaches should incorporate device design, human factors, validation methods and surveillance of reprocessed devices in healthcare facilities, among other considerations.

CDRH also has made it a priority to incorporate patient preferences in regulatory decision-making. The FDA issued draft guidance earlier this year that discusses the main factors sponsors and other stakeholders should consider when collecting patient preference information for use in applications (IDDM, May 15). The remaining items on the regulatory science priorities list are:

• Leveraging “Big Data” for regulatory decision-making;
• Leveraging evidence from clinical experience and employing evidence synthesis across multiple domains in regulatory decision-making;
• Developing computational modeling technologies to support regulatory decision-making;
• Enhancing performance of health information technology and medical device cybersecurity;
• Incorporating human factors engineering principles into device design;
• Modernizing biocompatibility/biological risk evaluation of device materials;
• Advancing the methods to predict clinical performance of medical devices and their materials; and
• Advancing the use of patient-reported outcome measures in regulatory decision-making.

The full report is available here: www.fdanews.com/102615-CDRH-priorities.pdf. — Elizabeth Hollis