Background
The U.S. FDA’s Center for Devices and Radiological Health (CDRH) is responsible for protecting public health by ensuring timely access to medical device safety data. Currently, adverse event reports are published in the MAUDE database with a 1–3 week delay due to monthly batch uploads.

 

 

 

Problem
This lag creates a blackout period where the public and developers cannot access up-to-date safety data. A report submitted on 10/1/2025, for example, wouldn’t be publicly available until ~11/7/2025. Modern tools like Riskbased.ai can detect safety signals in near real-time—but only if data is updated daily or weekly. 

 

 

Opportunity
FDA CDRH staff have confirmed such updates are technically feasible, but currently lack the resources to implement this improvement:

• “We have no immediate plans to make major MAUDE changes at this time... we will add your request to the backlog.” —FDA

 

 

Petition
We urge the FDA to implement daily or weekly MAUDE updates to improve transparency, accelerate safety signal detection, and better protect public health. These changes would provide critical visibility into emerging device risks—when timing matters most.

We specifically request that:

• Bulk downloads for daily data be made available in OpenFDA format
• Search limits be removed beyond the current 500-record cap
• Real-time access be enabled for manufacturers, researchers, and public data platforms

 

Add your voice—sign the petition.