Devices

Citizen Petition Seeks Database for Medical Device Labels

A patient safety advocacy group has filed a citizen petition urging FDA to create a comprehensive public database of medical device labels, arguing that greater transparency is needed to support informed decision-making, research, and postmarket oversight. The petition asks the agency to publicly post all labels, labeling, and instructions for use for FDA-regulated medical devices, ideally by expanding the existing Devices@FDA database. The petition was filed by Harmed Americans for Reform in Medical-Device Safety Corp. (HARMS), a nonprofit organization focused on device safety and accountability.

In the filing, petitioners argue that while FDA maintains a robust public database of drug labeling through Drugs@FDA, there is no comparable, comprehensive resource for medical devices. Although the agency publishes labels for some high-risk devices approved through the premarket approval pathway, most moderate- and low-risk devices cleared via the 510(k) pathway do not have publicly available labels or instructions for use, according to the petition.

The group contends that FDA already has both express and inherent statutory authority to regulate device labeling and to disseminate information to the public. Manufacturers are required to submit proposed labeling as part of device approval or clearance applications, and to update labeling when new information emerges, the petition notes, meaning the agency would not need to collect new data to make labels publicly available.

According to the petition, a centralized database of device labels would provide clinicians, patients, and health systems with clearer information about approved uses, contraindications, and risks, supporting more informed treatment decisions. The filing also highlights potential research benefits, including improved identification of safety signals, analysis of regulatory impacts, and tracking of device innovation over time.

The petition further argues that public access to historical and current device labeling could strengthen postmarket enforcement. Device liability cases often hinge on the contents of labels and instructions for use, and linking label information with adverse-event data could help regulators and researchers identify patterns of misconduct, safety issues, or billing irregularities more quickly.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome