Dive Brief:
- The Food and Drug Administration has expanded its early alert communication initiative to cover potentially high-risk removals or corrections for all medical devices, the agency said Monday.
- Officials announced a pilot of the initiative late last year. Since then, the agency has issued early alerts shortly after companies have told customers about issues with certain medical devices.
- The FDA said the pilot was successful, leading it to expand the program beyond the initial five therapeutic areas and include potentially high-risk safety events of all medical devices.
Dive Insight:
The FDA began the pilot to cut the gap between company and regulatory communications on potentially high-risk medical removals or corrections. Months can pass between a company contacting customers and the FDA publishing a recall notice. Early alerts allow the FDA to provide more timely information on a safety issue while its staff work to formally classify and communicate the recall.
Evidence of the impact of the pilot emerged shortly after the FDA began the program. In December, the FDA posted an early alert 14 days after Medline wrote to customers about an issue with its fluid delivery sets. Earlier in 2024, nearly four months passed between Medline telling customers about another issue and the FDA publishing a Class I recall notice.
The FDA’s list of recent early alerts includes 19 entries going back to March, including four notices posted in the past two weeks. Abbott, BD and Johnson & Johnson’s Abiomed are the subjects of the three most recent early alerts.
In the pilot project, the agency limited early alerts to potentially high-risk device removals or corrections related to cardiovascular, gastrorenal, general hospital, obstetrics and gynecology, and urology. The FDA has now lifted those restrictions and will issue early alerts about potentially high-risk recalls of any type of medical device.
