510(K) SUBMISSION (PREMARKET NOTIFICATION)
Why should I choose
Smith Associates for my 510(k)?
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.
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
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