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 ...
CollaborateMD, a cloud-based revenue cycle management solutions company, is releasing its real-time claims submission and editing software this spring. The new software will allow users to submit ...
On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance ...
EMC this week announced Document Submissions Manager for electronic common technical document (eCTD) software, designed to simplify the management, assembly, and delivery of drug applications to ...
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