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.

Although there is a database for drug labeling information called FDALabel for drugs, there is no similar database for devices, except for high-risk devices that receive premarket approval (PMA). FDA does not publish labels for the majority of moderate to low-risk devices cleared through the 510(k) pathway.

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 noted that “despite typically being lower risk than PMA devices, 510(k) devices can still be quite risky such as a recently cleared brain implant. Serious safety concerns may also emerge over time, as with transvaginal mesh.”

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.”

It would also empower consumers to make better decisions about their healthcare. “Although patient interest in this information may be stronger when the procedure involves sedation (e.g., knee replacement) than when it involves routine care (e.g., an x-ray), patients should be able to decide for themselves what is important.”

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.

A centralized database can also provide better protection for device manufacturers against legal actions, especially when risk information is included in the labeling. “Lawsuits against manufacturers for failing to disclose or misrepresenting risk information are based on the information provided in the device label. Firms could link device label data to other adverse events databases to identify potential manufacturer misconduct, billing irregularities, and personal injury claims.”

The authors state that creating the database would require only a relatively small amount of effort. Once the device is approved, the proposed labeling could be added to the database along with instructions for use. The authors also recommend that the database should keep a record of the chronological changes to the labels.

In an interview with Focus, Simon said the proposal aligns well with HHS Secretary Robert J. Kennedy’s goal of “radical transparency” at FDA and other agencies. (RELATED: This Week at FDA: Trump fires thousands of federal workers, Kennedy sworn in as HHS secretary, and more, Regulatory Focus 14 February 2025)

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

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