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 510k 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 510ks.
Submissions To The FDA
- 510(k) Submission & Pre-Submission
- PMA/BLA Submissions
US Agent Services
Human Factors/Usability Studies
- HF & Design Control
- HF/Usability & 510k
- HF/Label Comprehension
Quality System Compliance
- Quality System SOPs Part 820
- Quality System Audit
- 483 & Warning letter Response
- Recall and Corrections
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.
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.
We understand that submitting a 510(k) can be costly and in some cases crippling due to FDA’s requirements for sterility validation, package integrity studies, shelf life studies, accelerated aging studies, biocompatibility tests, EMC and general electrical safety tests, performance tests, comparative bench tests, human factor studies, and in some cases clinical studies.
Because we are business people like you, we instituted a FIXED FEE for our consulting services that hopefully will meet your budgetary needs. Our FIXED FEE requires 50% payment to start the project and the remaining 50% is due prior to us hand-delivering your submission to the FDA Document Center in Silver Spring, Maryland. There will be NO ADDITIONAL FEES for our consulting services, as they relate to your 510(k) submission, which equals NO SURPRISES. Please contact us for a quote for your submission.
The first steps in product development (concept and feasibility) are determining if there is a market for your product, can your product achieve its’ financial objectives and what are the regulatory burdens for achieving FDA 510(k) or PMA clearance.
It is just as important for Smith Associates, as it is for you, to determine if we are the right consulting firm to assist you through the FDA clearance process. Smith Associates provides FREE product classification, product code and quality system requirements for your medical device.
Smith Associates is located 20 minutes from the FDA. All of our submissions and responses are hand delivered to and date-stamped by the Document Room. The FDA has changed their rules on review time with second responses moving to an interactive review resulting in mere days or sometimes hours to respond to FDA’s questions. We can handle your active reviews by being not only in the same time zone but in the same area.
All of Smith Associates’ review process is transparent with the client. You will be informed in real time during the review process and FDA interaction. All submissions and correspondence are your property.