The Food & Drug Administration plans to launch a public database of recall data this fall, another element in the agency’s quest to become more transparent.
The data, on recalls of medical devices, food products and drugs, will be compiled in a searchable, online database. The data will also be made available in a downloadable XML format.
The information to be posted will include brand and company names, product descriptions, the problem that prompted the recall and product photos when available, FDA transparency coordinator Afia Asamoah told theSunlight Foundation.
Most recalls are made on a voluntary basis; the FDA does not have the power to require more data from companies ’ a fact it would like to remedy, according to the foundation. The agency wants the ability to compel companies to release “the identity of the product that is being recovered or corrected, the estimated number of medical products (e.g., number of tablets or devices) or food items that are subject to recovery or correction, the reason for the action to recover or correct the product, and the geographic distribution of the product,” according toan FDA transparency report.
The watchdog agency isn’t limiting itstransparency push to data and reports. It’sannounced aslewofinitiatives since President Barack Obama cleaned house and brought in a new slate of administrators last year. They include moves to release more data on its 510(k) clearance and pre-market approval processes, a transparency website for the Center for Devices & Radiological Health and even a “Transparency Task Force.”
By MassDevice Staff
The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.Visit website | More posts by Author
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