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If you’ve ever received a Form 483, you know the FDA gives you one chance to make things right: a 15-day window in which to submit to the agency a written response that addresses the observations in the 483 and outlines your plans for improvement. Can you fix your corrective and preventive action (CAPA) problems in 15 days? It’s not likely, but you can show the agency you understand the issues and are committed to resolving them. 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
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
Boston Scientific is expanding its portfolio of cardiac devices through its $1.75 billion purchase of Toronto, Canada-based Baylis Medical, which specializes in minimally invasive heart access products. Read More