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As medical instruments have become more complex, “reprocessing has become more complicated and time consuming,” said Sharon Silas, acting director of the GAO’s health care team. Read More
Citing post-market safety concerns about the delivery accuracy of infusion pumps, Health Canada is updating the evidence requirements to demonstrate the accuracy of these devices through performance testing for new and amended license applications. Read More
The FDA extended the compliance date for Global Unique Identification Database (GUDID) submission requirements for combination products, giving devicemakers another year to comply. Read More
The FDA issued a list of medical device accessories that it believes are safe and effective enough to be categorized as Class I and requested public feedback on the proposed list. Read More
The Global Diagnostic Imaging Healthcare IT & Radiation Therapy Trade Association is calling on the FDA and the Medical Device Single Audit Program consortium to review the program’s inconsistencies and revise companion documents so devicemakers and auditing organizations are clear on expectations. Read More