The artificial intelligence, internally dubbed CDRH-GPT, is intended to help staffers at the agency’s Center for Devices and Radiological Health, a division responsible for ensuring the safety of devices implanted in the body, as well as essential tools like X-rays and CT scanners.
The division was among those affected by the sweeping mass layoffs at the Department for Health and Human Services earlier this year. While many of the device reviewers were spared, the agency eliminated much of the backend support that enables them to issue approval decisions on time.
The work of reviewers includes sifting through large amounts of data from animal studies and clinical trials. Depending on the applicant, it can take months or even over a year — which an AI tool could feasibly help shorten.
Experts, however, are concerned that the FDA’s push toward AI could outpace what the technology is actually ready for.
Since taking over the agency on April 1, Commissioner Dr. Marty Makary has pushed to integrate artificial intelligence across the FDA’s divisions. How this move into AI could affect the safety and effectiveness of drugs or medical devices hasn’t been determined.