CDRH Requests Labeling Changes on Certain Pen Needles

Regulatory NewsRegulatory News | 27 September 2018 |  By 

In a letter to manufacturers of pen needles designed to be used with injectors, the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) called for labeling updates to address the adverse events associated with improper patient use.
The request comes after the agency became aware of the reported incidents of hyperglycemia, diabetic ketoacidosis and at least one patient death through medical device reports and FDA’s adverse event reporting system, among other sources, according to the 26 September letter.
It seeks to specifically address user failures to remove inner needle covers before insulin injections, which can prevent the often life-saving medication from being delivered.
The letter asks that manufacturers review the most recent labeling and training materials to ensure that the instructions for use (IFU) on pen needles that are regulated under product code FMI—hypodermic single lumen needle—are adequately conveying safe use.
“While some manufacturers provide clear IFU to remove both the outer cover and the inner needle cover, the FDA found that some manufacturers do not provide this information, or the information may be confusing,” wrote CDRH Deputy Director and CMO Aron Yustein.
It also encourages manufacturers to consider adding a warning to the labeling of these pen needles similar to what is stated below.
Warning: Remove both the outer cover and the inner needle cover before an injection. If both the outer cover and the inner needle cover are not removed before use, the medication or dose may not be injected, which may result in serious injury or death.
CDRH does not anticipate that a new 510(k) would be necessary to implement the requested label changes, though the decision-making process and justification should be internally documented. Revisions to 510(k)s can be submitted for feedback prior to implementation.


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Tags: 510(k), CDRH, Labeling

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