Nasdaq

FDA Accepts Tasly's Device Master File, Setting First Quality Control Standard For MSCs

(RTTNews) - Tasly announced that, in a landmark move for the cell therapy industry, the U.S. Food and Drug Administration has accepted a Device Master File (DMF) describing the first dedicated quality ...
RAPS

FDA Drafts Guidance on Type V DMFs for Combination Products

The US Food and Drug Administration (FDA) on Monday issued draft guidance detailing when a Type V drug master file (DMF) can be used to provide information about Center for Drug Evaluation and ...
RAPS

FDA guidance outlines where to send “cross-center” master files

The US Food and Drug Administration (FDA) has issued a draft guidance to industry that specifies where sponsors should submit “cross-center” master files (MFs) that are referenced and intended to ...
Medical Device and Diagnostic Industry (MD+DI)

QMSR Compliance Challenges: Critical Implementation Gaps Manufacturers Must Fix

Three months in, most medical device manufacturers have completed their initial gap assessments — but the harder work is only ...
Business Wire

Andersen Sterilizers & Andersen Scientific First Awardee in FDA’s 510(k) Ethylene Oxide Sterility Change Master File Pilot Program

HAW RIVER, N.C.--(BUSINESS WIRE)--Andersen Sterilizers and its sister company, contract sterilization specialist Andersen Scientific, were awarded the very first master file in the FDA's 510(k) ...