As discussed in the final guidance, FDA anticipates that the agency and industry will need up to 60 days after the publication of this guidance to operationalize the recommendations discussed; however ...
Editor's Note: A previous version of this article incorrectly stated the guidance did not apply to device constituent parts of a combination product. The US Food and Drug Administration (FDA) this ...
On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance ...
PRINCETON, N.J., Sept. 19, 2023 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced it has successfully supported 300 completed submissions to ...
SANTA CLARA, Calif.--(BUSINESS WIRE)--HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful personalized insights, today announced it ...
LEHI, Utah--(BUSINESS WIRE)--Owlet, Inc. (NYSE: OWLT) (the “Company”) announces that the U.S. Food and Drug Administration (“FDA”) has accepted for substantive review the Company’s de novo ...
The US Food and Drug Administration (FDA) has released draft guidance for sponsors outlining its thinking about the documentation needed to support the agency’s evaluation of device software functions ...
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