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The FDA and the National Institutes of Health are seeking comments on a new draft clinical trial protocol template for NIH-funded investigators. Read More
Industry and the FDA appear to be far from reaching an agreement on the fourth iteration of the Medical Device User Fee Act, based on newly released meeting minutes posted last week. Read More
The FDA is aiming to clarify the types of data it would like sponsors to submit to support an IDE for clinical trials involving devices targeting neurological disease progression. Read More
The FDA wants to know more about the challenges third-party entities face in maintaining or restoring devices to their original or current specifications. Read More
Following widespread media attention over patient injuries and increased scrutiny by the FDA, manufacturers of certain types of metal-on-metal hips now will have to submit premarket approval applications to keep their devices on the market. Read More
The FDA has shed some light on what factors it wants companies to consider when developing devices to eliminate or reduce design-related problems that contribute to or cause unsafe or ineffective use. Read More
Manufacturers can get earlier access to the market under a new pilot program launched last week in South Korea that unifies the country’s medical device approval review process and the health technology assessment. Read More