The sudden firing of Food and Drug Administration employees over the weekend is already affecting medical device submissions. The cuts could delay the time it takes to bring new products to market and ...
The U.S. Food and Drug Administration’s Center for Devices and Radiological Health made the CDRH eSubmissions Pilot Program available and has expanded it to include more participants. The program is a ...
SUNNYVALE, Calif., March 17, 2026 (GLOBE NEWSWIRE)-- BioCardia ®, Inc. [NASDAQ: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, ...
New set of 73 Real World Evidence examples illustrate how RWD can support rigorous validation of novel device software ...
In 2006, FDA launched what the agency refers to as a postmarket transformation initiative. Developed through FDA's Center for Devices and Radiological Health (CDRH), the initiative is designed to ...
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