FDA should establish a public database of device labels, experts say

 The US Food and Drug Administration (FDA) should establish a public database of medical device labels that is accessible to patients, healthcare providers, and consumers. This database would help physicians make informed decisions, allow researchers to study the safety of devices, and better protect manufacturers from enforcement actions, experts said in a recent viewpoint article published in JAMA.


This lack of labeling deprives the public of a valuable resource that could “improve decision-making, innovation, and public health,” wrote David Simon, a law professor at Northeastern University and co-director of the Amy J. Reed Collaborative for Medical Device Safety in Boston, and colleagues.





The authors note that centralizing the information could improve physicians’ decision-making about which device to choose for patients. According to the authors, physicians report “limited knowledge about the device review process.”


 


 
The database would also allow researchers to better recognize safety signals, evaluate the impact of existing regulations, and foster innovation. Much like drug labels, device labels can offer insights into the safety signals researchers might find in adverse event reports and insurance claims databases. Additionally, this information can be utilized to monitor firm innovations over time, assess how firms respond to regulatory changes, and uncover innovative applications using artificial intelligence and machine learning software.


Simon said he has not yet communicated this plan to current FDA employees, although former FDA employees supported the idea. “We have not talked to anyone currently at FDA about this proposal, although we would love to do so. We think it would benefit society and patients.”


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