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International device regulators laid out their agenda for the next two years, with plans to finalize a regulatory framework for software as a medical device and guidance on international sharing of adverse event data in 2015. Read More
Devicemakers will have 13 new product-specific guides by the end of the year to tell them what quality-related metrics FDA investigators will focus on during site inspections, agency officials said Tuesday. Read More
When preparing 510(k) submissions, devicemakers should never forget that the “devil is in the details,” a regulatory adviser says. Companies would do well to have a second set of eyes review the submission after any work or changes to guard against mistakes. Read More
The FDA has withdrawn a proposed rule reclassifying external pacemaker pulse generators from Class III to Class II and is now issuing a proposed order to make the reclassification. Read More