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The COVID-19 pandemic has brought about an “explosion” of interest in consumer diagnostics, but it remains to be seen if the regulatory flexibility the FDA has shown toward those products will continue beyond the public health emergency, a leading healthcare industry attorney says. Read More
The FDA takes on average more than five months (163.4 days) to review devices for 510(k) clearance, according to a law firm’s analysis of almost 12 years’ worth data from the FDA’s Center for Devices and Radiological Health. Read More
In a move that is unlikely to resolve the matter, the company has added a disclaimer on its website stating that the Smart Sock “is an information-gathering product for use with healthy babies only. It is not a medical device.” Read More
Australia’s Therapeutic Goods Administration (TGA) describes how it classifies “active” medical device products in a newly released guidance. Read More
Devicemakers scrambling to classify or reclassify their products under the EU’s Medical Devices Regulation (MDR) now have some help in the form of a new guidance. Read More
The FDA is reclassifying some surgical staplers for internal use from lower-risk Class I devices to higher-risk Class II devices that require premarket reviews. Read More
The Centers for Medicare & Medicaid Services (CMS) proposes to withdraw the Medicare Coverage of Innovative Technology (MCIT) final rule that is scheduled to go into effect on Dec. 15 and is pondering suggestions from the public about what should go in its place. Read More
The FDA’s 9-member Patient Engagement Advisory Committee (PEAC) met yesterday in a public meeting to discuss how devicemakers and the FDA can better share information during recalls. Read More