FDA Withdraws Proposed Rule on Electronic Labeling for Cert…


The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced Wednesday that it was withdrawing a proposed rule that would have sought to reduce an increasing number of adverse events from home-use medical devices with an online database of certain device labels.
 
The proposal would have required companies to submit labels and package inserts in electronic format so they could be more available.
 
“Home-use devices tend to become separated from this product labeling over time, and the absence of this information may lead to adverse events,” the agency said in October 2016. However, the agency also noted the  costs for industray, in addition to costs FDA would incur to establish and maintain the online labeling database.
 
Following the release of the proposal, industry pushed back, with AdvaMed saying the proposal “will do little, if anything, to enhance public health and may result in unintentional negative consequences.”
 
AdvaMed also sounded skeptical that device users would seek labeling information directly from an FDA database: “In our experience, device users—as with users of general consumer products—would first seek labeling information on the manufacturer’s website or through an internet search engine such as Google.”
 
Withdrawal
 
In deciding to withdraw the rule, FDA seemed to agree with AdvaMed, noting “several adverse comments” challenging the database as “unduly burdensome” for both the agency and industry, “without efficiently enhancing public health.”
 
“Additionally, concerns regarding the proposed format and potential costs for industry to fully implement were also raised. Based on the adverse comments, this rulemaking would benefit from being withdrawn at this time and reconsidered. The Agency plans to reconsider its approach and solicit further public input at a future date,” FDA said.
 
Meanwhile, the agency on Wednesday also pulled a separate proposed rule on laser products, saying that it referenced an international performance standard that is now being revised to reflect advancements in technology. “FDA wants to have the most current international standard as a reference before publishing a final rule on laser products,” the agency said.
 
Federal Register

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