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The FDA has issued draft guidance standardizing the way companies report computational modeling and simulation studies, paving the way for more computer modeling in medical device trials. Read More
The FDA does not review new clinical data in considering most cardiac implantable electronic devices, according to a study in last week’s Journal of the American Medical Association — a fact the authors say may have contributed to several high-profile recalls. Read More
The FDA’s new custom device exemption, granted under FDASIA, does not apply to 510(k)-cleared devices that are modified but still retain their original intended use and could be clinically studied, the agency clarifies in a draft guidance. Read More
Ocular Therapeutix’s ReSure Sealant kit won FDA approval last week, making it the gel for sealing small incisions in the eye after cataract surgery. Read More
The Central Drugs Standard Control Organization has issued detailed guidance on the registration, reregistration and import of notified in vitro diagnostic kits and on the import of non-notified kits, with the aim of speeding submission reviews and easing the move to electronic submissions. Read More
The FDA Tuesday laid out separate requirements for 510(k)s for over-the-counter and prescription point-of-care blood glucose tests — a shift from current guidance that applies to all blood glucose monitoring systems. Read More