Consultants Specializing in Regulatory Affairs for FDA Compliance

510(k) Submission (Premarket Notification)

Why should I choose Smith Associates for my 510k?

There may be many factors in your selection process but listed below the most important.

1. 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. View all 510(k) clearances.

2. FIXED FEE – Controlling your Budget

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.

3. PRODUCT CLASSIFICATION – and subsequent regulatory burden

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.

4. Location – Interactive Deficiency Response

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.

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.

510K General Consulting/Strategic Planning

Smith Associates can assist you in strategic planning for your 510k 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
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