This article discusses the most recent FDA pilot program which supports streamlined regulatory submission processes for medical device manufacturers enhancing efficiency for FDA reviews.
Learn more about the authors below.
Published Article
PUBLISHED ARTICLE
FDA Pilot Program Supports Streamlined Regulatory Submission Processes for Medical Device Manufacturers
Published In: Medical Design Briefs (MDB)
April 11, 2023
Audrey Turley
RM (NRCM), CBA (ASQ)
Director of Expert Advisory Services & Biocompatibility Expert
Audrey Turley has over 25 years of experience working in research, laboratory, and test design functions in the medical device industry. She is a biocompatibility expert, having performed all the in vitro tests offered at Nelson Labs, which include cytotoxicity (MEM and agar overlay), hemolysis (PTT, PT, complement activation, blood circulation, ASTM, and NIH methods),...
