Why should I choose Smith Associates for my 510(k)? There may be many factors in your selection process, but listed below are the most important. EXPERIENCE Our consultants have over 100-years of FDA regulatory and sales/marketing backgrounds and business ownership. We understand not only the regulatory side of your submission but also the marketing side. We understand the financial pressures placed on all businesses when trying to comply with FDA regulatory requirements and the costs of having to perform expensive testing in order to demonstrate the safety and effectiveness of your device to that of your predicate device. At the end of the 510k process, it is important to insure your cleared marketing claims provide your salesforce or distributors the necessary sales claims to be competitive. Smith Associates has over 280 successful 510(k) clearances across all CDRH reviewing Branches. FIXED FEE PRODUCT CLASSIFICATION LOCATION TRANSPARENCY Pre-Submission The Pre-Submission is becoming an increasingly popular means to approach the FDA for assistance with various questions which a potential 510k, IDE or PMA submitter may have. In this more informal setting, the FDA has greater flexibility in answering your questions. Most testing performed for the 510(k) submission is based on FDA recognized standards. What do you do if the protocols for your test or study is outside of FDA’s recognized standard? Smith Associates will submit a Pre-Submission to the FDA, for a modest fee, to seek FDA’s input concerning your protocol or other questions you may have concerning your upcoming 510(k)/PMA submission. 510(k) General Consulting/Strategic Planning Smith Associates can assist you in strategic planning for your 510(k) and marketing access. These services are normally based on an hourly fee. Design review training and management according CFR 820.30 Overall general contractor and liaison with testing labs Clinical review for proposed device Protocol design for human factor studies Marketing surveys for proposed product Deficiency Response assistance for submitted 510k 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