On Thursday, Sen. Al Franken (D-Minnesota) sent a letter to Dr. Jeffrey Shuren, director at the Center for Devices and Radiological Health at the U.S. Food and Drug Administration, that urged the agency to include industry input on any recommendations the Institute of Medicine makes about changes to the 510(k) process. Franken said industry input was needed before any final changes are implemented.
Specifically, Franken wrote that “I believe that the industry contains a wealth of experience too often ignored in the device review process.”
On Friday, an FDA spokeswoman responded that the agency has taken multiple steps to ensure that industry has a voice in these discussions. Amanda Sena, who manages medical device-related issues at the agency’s Office of Public Affairs, said in an email that two public meetings have been held in addition to three town hall meetings and a number of meetings with individual stakeholders to discuss the 510(k) approvals process. There are also three public dockets on the subject.
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Sena noted that based on feedback from the medical device industry and their concerns about being able to continue innovating under new rules, the FDA will do the following:
- Publish guidance for industry to clarify when clinical data should be submitted to increase predictability and transparency.
- Develop a network of external experts who can use their knowledge and experience to help the agency address important scientific issues regarding new medical device technologies.
- Establish a new Center Science Council of senior FDA experts within the agency’s medical device center to assure more timely and consistent science-based decision making.
At the same time while encouraging innovation, FDA has to be cognizant of its other mission to ensure that the devices are safe, she said. For that the agency will:
- Establish a public database of important device information, such as medical device labeling and summaries of the basis for the FDA’s decision to clear specific devices.
- Require a brief description of scientific information regarding the safety and effectiveness known to the manufacturer for select higher-risk devices on a case-by-case basis through device-specific guidance.
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Meanwhile, the industry is waiting for the recommendations from the Institute of Medicine. Published reports from April show that the IOM has completed its internal review and is now soliciting comments from the industry. The report is expected this summer.
