Amid frustration at the slow pace and complexity of device regulation at FDA, the agency's unit focused on the device industry has made known some of the scientific work and available tools that could aid in product approvals.
The FDA's Center for Devices and Radiological Health (CDRH) calls these activities regulatory science in a report that trumpets some of the efforts to keep high standards for safety and efficacy in regulating devices. The report, called "Regulatory Science in FDA's Center for Devices and Radiological Health: A Vital Framework for Protecting and Promoting Public Health," notes that computer modeling of cardiovascular devices and standard measures of the durability and other attributes of spinal disc implants could help streamline device development and regulation.
"Investments in regulatory science help to maintain a robust medical device industry by reducing the time and resources needed to develop, assess and test new products," the agency said in a release today. "This can lead to quicker, more efficient device approvals, potentially decrease the size and duration of premarket clinical trials and speed the rate at which breakthrough technologies reach the market."
The report follows years of criticism about opaque regulatory guidelines and the agency's lack of consistency on the best pathway to approval for certain types of medical products.
- here's the release with a link to the full report