RAPS

Electronic Device Submissions: FDA Drafts Guidance

Thanks to the FDA Reauthorization Act of 2017 (FDARA), the US Food and Drug Administration (FDA) on Wednesday published a new draft guidance with “both binding and nonbinding provisions” related to ...
RAPS

FDA revamps device software premarket submissions guidance

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 ...
JD Supra

FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions

On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance ...
La Grande Observer

GeminiBio Submits Drug Master File (DMF) to FDA

WEST SACRAMENTO, Calif., March 13, 2025 /PRNewswire/ — Gemini Bioproducts, LLC (“GeminiBio”), a biopharma and advanced therapy raw materials supplier, and a portfolio company of BelHealth Investment ...
Seeking Alpha

BIO-TECHNE ANNOUNCES SUBMISSION OF FDA DRUG MASTER FILE FOR EXCELLERATE GMP IPSC EXPANSION MEDIUM SUPPORTING STEM CELL THERAPY

MINNEAPOLIS, Dec. 20, 2023 /PRNewswire/ -- Bio-Techne Corporation (TECH) today announced that it has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for its ...
ksn.com

Cellbox Solutions Submits Device Master File (DMF) to the U.S. FDA

Submission represents an important step towards establishing the Cellbox Live Shipment Technology as a new standard for warm chain logistic in the cell therapy sector Cellbox customers can now ...
MD&M East

Paris-Based Medical Device Company Emerges From Stealth for FDA Submission

Paris-based medical device startup Tulyp Medical has emerged from stealth and submitted a 510(k) application to FDA for its intelligent pressure-driven perfusion device. The company has seen positive ...