510k Submission2018-07-18T12:26:29+00:00

510(K) SUBMISSION
(PREMARKET NOTIFICATION)

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.

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

We service all sized companies and classifications within your budget.

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