An investigational device exemption (IDE) allows the investigational device to be legally used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification (510K). Involved in this process is an approved clinical protocol, administrative monitoring plan, IRB approval, patient informed consent form, etc. in order for the manufacturer to gather the clinical information on humans to establish the safety and effectiveness data. Smith Associates has assisted manufacturers in submitting IDEs that have included 10 year saline and gel-filled breast saline implant studies, testicular implants, warming cabinets, ADHD diagnostic blood tests and HTLV diagnostic tests. Our Services Include: Clinical review for protocol bibliography Protocol development Case Report Forms Administrative Plan Study Data Management Preparation and Submission of IDE to the appropriate reviewing branch Whatever the route required for your company’s medical product, Smith Associates is experienced in every aspect of the process and will assist you in addressing the mandatory IDE requirements. ABOUT US Since 1994, under the direction of E J Smith, President, Smith Associates has specialized in regulatory services for the medical manufacturers of medical devices, in vitro diagnostics, biologics and blood. This includes the most common route to clearance in the United States, the 510(k) submission (PMN), and also Pre Submissions, Pre-IDE, PMA, and Human Factors studies required for validation of the device by the intended use for inclusion in 510(k)s. QUICK LINKS Home Regulatory Services Quality System Human Factor Studies Our Projects Our Clients Contact Us COMPANY INFO Smith Associates P.O. Box 4341 Crofton, MD 21114 United States Local: (410) 451-0639 Fax: (410) 793-0448 Toll Free: (888) 729-9674 Copyright 2021 GLOCOM | All Rights Reserved | Powered by NWOL | English