CDRH has proposed implementation of an online repository of medical device labeling, but the idea is not faring well with device makers. Although FDA says the public database, which includes making device photographs available, would not disclose proprietary information, making medical device labeling broadly in such a repository may inadvertently lead to public confusion, says Jeff Secunda, vice president, technology and regulatory affairs, for AdvaMed.

Secunda points out that many device labels contain technical or complex information intended for hospitals or practitioners and may not be clearly understandable to the lay audience.

CDRH says the database might be similar to the labeling repository specific to drugs that is already available through DailyMed on the National Library of Medicine’s website. The repository could eventually cover all classes of devices and could facilitate patient access to information on what types of devices are available for their medical condition and how the devices could be used. The agency says such a repository could also assist healthcare professionals access labeling that may not always accompany a medical device.

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