Ahead of a 4-day public meeting blitz, the FDA released a preliminary proposal for strengthening medical device post-market surveillance.
The plan features 4 sections, including the creation of a unique device identifier system and promoting use of national registries.
"Although the United States has a robust postmarket medical device surveillance system, we believe our system can be strengthened by implementing four key changes to our existing program," according to the report. "It bears emphasizing that modernizing medical device postmarket surveillance is a long-term effort. Our proposed strategic changes are intended to complement our existing programs."
The report precedes next week’s public meetings and workshops covering ways to strengthen the FDA’s medical device surveillance systems, priorities in surveillance improvement and how to leverage registries to improve monitoring through a device’s total life-cycle.
The FDA been in the hot seat in recent months as a slew of high-profile medical device recalls, including St. Jude Medical’s (NYSE:STJ) Riata defibrillator leads and DePuy Orthopaedics’ metal-on-metal hip implants, have some doubting the agency’s ability to protect the public from medical devices once they hit the market.
The slate of high-profile recalls have also spurred rebukes from legislators and citizen advocates.
The new plan aims to tackle some of those concerns using 4 main strategies:
- Establish a unique device identification system and promote its incorporation into electronic health information.
- Promote the development of national and international device registries for selected products.
- Modernize adverse event reporting and analysis.
- Develop and use new methods for evidence generation, synthesis and appraisal.
Some of the agency’s goals, especially the UDI tracking program, have been a long time coming.
Congress initially approved the UDI program in 2006 to enable tracking of medical implants and to add medical devices to the Sentinel post-market surveillance program that currently monitors prescription drug safety.
Earlier this summer the FDA issued a proposed rule on the UDI system, which would require most medical devices to carry labels with unique codes and scannable barcodes that will allow healthcare providers, regulators and the public at large to track the devices and monitor safety.
Later this month the FDA will host a Florida gathering of medical device and healthcare industry stakeholders for a discussion of the agency’s unique device identifier program for tracking and monitoring medical technology.