The FDA 510(k) Guidance
Rules, Regulations, Compliance, Substantial Equivalence, or What?
G. Wayne Moore, B.Sc., MBA, FASE
As an ultrasound medical device regulatory expert, I receive a great many questions throughout the year regarding exactly what the FDA Guidance documents are. For example, are they requirements, rules, suggestions, or regulations? Below you will find the link to the FDA page that has the new Guidance for ultrasound systems and transducers that will be released this July. Now, the general answer to the question above is that the document acts as a guide for sponsors, i.e., those actually submitting a 510(k), to follow as they populate their submission with information the FDA believes will allow them to determine if the submitted device is substantially equivalent to a currently marketed device. So, the various numbered elements in the Guidance document provides a path for the sponsor to follow – however, and this is an important point, it is not prescriptive in how the sponsor must respond to each particular point. In other words, the sponsor is free to respond to an item in one or more of the sections within the Guidance in a manner that is variant from the Guidance. The FDA explicitly states this in the Guidance. However, if a sponsor follows their own path, they must show objective engineering or scientific data that demonstrates the validity of that approach. This is not a trivial exercise, nor do I generally recommend to a client that they do this in their submission. Remember, the goal of a successful 510(k) submission is to establish substantial equivalence to a product that is currently on the market so you can begin selling, not to try and impress the FDA reviewer with how novel, delightful, or innovative your device is (spoiler alert, that will never happen). So not following the Guidance is analogous to leaving the trail in a dark scary jungle and trying to hack your way through and blaze a new trail (another spoiler alert – you will be eaten by a fierce animal).
As a side note to the Guidance document you will find in the Appendix what changes to a finished ultrasound device, including the transducer, will require a new 510(k) – this is a good tool to determine if what you plan on doing to that device constitutes remanufacturing, currently an essential topic with regard to the 3rd Party repair docket.
Until Next Time,
About the Author, G. Wayne Moore:
A 30-year veteran of the diagnostic ultrasound market Wayne has held senior level positions with several major medical equipment manufacturers, including Honeywell Medical Systems and Siemens Medical Solutions. Wayne has been directly involved in the development and commercialization of more than 15 technologically intensive ultrasound systems. He is widely published in diagnostic ultrasound literature, a sought after speaker at medical imaging conferences, has served as an expert witness in multiple ultrasound litigations, and holds more than 16 United States ultrasound related patents. Wayne obtained his MBA from the University of Denver – Daniels College of Business.
He was elected as a Fellow of the American Society of Echocardiography (FASE) in 2009.