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The FDA has set out a framework how devicemakers will be able to demonstrate products are as safe and effective as a predicate device under an expansion of the agency’s abbreviated 510(k) pathway for certain, well understood device types. Read More
The FDA is introducing a new, voluntary program for certain medical devices and device-led combination products that are expected to significantly improve the safety of treatments for a disease or condition deemed less serious than those eligible for the breakthrough devices program. Read More
Under the FDA’s MDUFA IV commitments, the agency is developing electronic submission templates for device sponsors, but it says it’s “not feasible to describe and implement the electronic formats that would apply to all submissions in a single guidance,” in a draft guidance released last week. Read More
The FDA laid out its latest thinking on digital health tools in a package of six guidances released last week, highlighting the continued need for innovation. Read More
Medical organizations will have to provide the agency with information on their monitoring of device safety and on the availability of devices. Read More
The FDA said it “continues to receive a high volume of pre-submissions from industry requesting feedback about the necessary data to support pivotal clinical studies and marketing applications for a wide variety of device designs intended for weight loss.” Read More
The best way to improve innovation and safety in the 510(k) program “is to drive innovators toward reliance on more modern predicate devices or objective performance criteria,” said CDRH Director Jeffrey Shuren. Read More