More medical device reporting laws are coming and now is the time to prepare. Consider this, for example, from recent FDA advisories:
Section 519(a)(1) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360i(a)(1)) requires every manufacturer or importer to report ‘‘whenever the manufacturer or importer receives or otherwise becomes aware of information that reasonably suggests that one of its marketed devices: (A) May have caused or contributed to a death or serious injury, or (B) has malfunctioned and that such device or a similar device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur * * *.’’
Complete, accurate, and timely adverse event information is necessary for the identification of emerging device problems. Information from these reports will be used to evaluate risks associated with medical devices which will enable FDA to take appropriate regulatory measures in protection of the public health under section 519 of the
When these and other relevant device reporting and identification regulations are fully enacted it seems clear that manufacturers and the health facilities that use medical devices in patient care will need ways to track the devices right down to their serial and lot numbers. Clearly, the proper labeling of these devices will be critically important for manufacturer compliance under the new FDA rules being passed and written into law by Congress.
In the making of a sophisticated medical device it is understandable that little attention can be given to how, where and when it will be labeled. That, at least, has been the case for many years. But now, the FDA in my view is coupling the importance of a life-saving device with a potentially life-saving label. This makes sense.
If you’re looking ahead to medical device labeling challenges and need an expert partner with long experience in labeling as well contemporary expertise in global product marking standards in the healthcare industry, we at Loftware can help and show you how we’re meeting this opportunity for other major healthcare product providers.