'Predicate device' presentation slideshows

FDA Regulation of In Vitro Diagnostic Tests

2.11k views • 46 slides

FDA Regulation of In Vitro Diagnostic Tests

736 views • 46 slides

FDA Regulation of In Vitro Diagnostic Tests

648 views • 46 slides

SoCal IP December 4, 2013 Michael H. Cohen, JD, MBA Michael H. Cohen Law Group 468 N. Camden Dr.

362 views • 36 slides

RHAIR Society for Academic Emergency Medicine Boston, Massachusetts May 31, 2003

Regulation of Medical Devices Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Food and Drug Administration. RHAIR Society for Academic Emergency Medicine Boston, Massachusetts May 31, 2003. Outline. Who we are

480 views • 27 slides

Mixing and Injection System for Polyurethane Foam Scaffolds

Mixing and Injection System for Polyurethane Foam Scaffolds. Michael Scherer Dustin Dowell Andrew Solomon. March 13 th , 2008. Design Objectives. Novel device which effectively mixes two-component polyurethane foam scaffolds for bone injection in situ

417 views • 18 slides

EMBOL-X Aortic Filter FDA Presenters Catherine Wentz Julie Swain, MD Gerry Gray, PhD

EMBOL-X Aortic Filter FDA Presenters Catherine Wentz Julie Swain, MD Gerry Gray, PhD. Brief Description.

249 views • 8 slides

510(K) Submission - A Comprehensive and an Updated Overview

Why should you attend: The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) prescribes the premarket notification requirements. The premarket notification [510(k)] is the most common pathway to market for medical devices including in vitro diagnostic medical devices (IVDs). For More Details: Email: david@grcts.com Tel: 1-248-233-2049 Web: www.grcts.com

119 views • 7 slides