Reprocessed SUD Recall Underlines Sec. 301 Branding Concerns – OEMs
This article was originally published in The Gray Sheet
Executive Summary
A recent recall by reprocessor MedSurg Solutions could spur FDA to change its format for recall notices
You may also be interested in...
Reprocessors Forge Ahead Despite Heavy Regulatory, Political Attention
Recent changes to federal device branding requirements do not pose a significant barrier to third-party reprocessing, according to Alliance Medical President and Chief Operating Officer Rick Ferreira
Reprocessors Forge Ahead Despite Heavy Regulatory, Political Attention
Recent changes to federal device branding requirements do not pose a significant barrier to third-party reprocessing, according to Alliance Medical President and Chief Operating Officer Rick Ferreira
MDUFMA Guidance Forecast: E-Labeling, Appeals, GMP Inspections
Legal concerns raised by FDA's Office of Chief Counsel likely will delay issuance of a planned Sec. 301 guidance, according to MDUFMA Implementation Director Joanne Less, PhD