The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has issued three new draft guidances as part of an effort to modernize its 510(k) Program for new products ...
FDA Issues Draft Guidance on Best Practices for Selecting Predicate Devices for 510(k) Notifications
The US Food and Drug Administration (FDA) has just issued a draft guidance entitled “Best Practices for Selecting a Predicate Device to Support a Premarket Notification 510(k) Notification.” This ...
There is a troubling loophole in the US Food and Drug Administration’s 510(k) pathway that allows for the approval of medical devices that are at a higher risk of recall, according to results of two ...
Looking to modernize the 510(k) process, yesterday the FDA announced its final guidance establishing the framework for the new Safety and Performance Based Pathway. The biggest change to the 510(k) ...
Five years after promising to fix a flawed regulatory pathway widely used by medical device manufacturers, the Food and Drug Administration has issued new guidelines to improve its so-called 510(k) ...
The U.S. FDA’s 510(k) program is yet again under assault, this time from the authors of a Jan. 10 article in the Journal of the American Medical Association (JAMA). The authors’ primary point seems to ...
LONG BEACH, Calif. -- Big Data may provide some answers to the many questions surrounding advanced catheter-based pulmonary embolism (PE) therapies, a buzzing field that otherwise has little evidence ...
Please provide your email address to receive an email when new articles are posted on . The FDA has granted de novo approval to Neuromod Devices’ Lenire, a noninvasive device for the treatment of ...
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