Medical devices under the umbrella of substantial equivalence don’t always need extensive clinical studies.
(You may find our post on clinical study versus IRB helpful to understand the reasons for this.)
That being said, certain aspects of a device can benefit from clinical claims that require data from in-use observations and measurements. The typical investor or leadership knee-jerk reaction is to get these studies started as soon as possible to either get an edge on the market value proposition or proof of concept for investments.
However, for the studies to be properly conducted, a set of rules are necessary on operations, acceptance criteria, on the ground instructions for conducting the study, etc. At this junction, if you are asking yourself what the acceptance criteria would be, chances are that you need an IRB study more than a clinical study to learn more about your product performance. We can draw a parallel between these and the engineering studies versus a verification study. One measures the product performance (engineering study), one judges it against the acceptable levels (verification).
If you think you have the acceptance criteria all set, then the next important step is to make sure you will get credit for the work you will do.
How will you write the protocols?
Who will review them?
Who will approve them?
How will people at clinics, hospitals, etc. execute the protocols?
Answering all these questions, and maintaining compliance with regulations as you do so requires a central system to smoothly organize things…i.e. a quality system.
For the purposes of medical device regulation, the FDA requires evidence that any data you submit as part of your premarket notification be gathered from a device that will be manufacturing equivalent to the one you sell to consumers.
In other words, you must be able to show quality records (in a quality system) for the design and manufacturing of the devices used in your clinical study.This is the only way you’ll get credit for the study data that you collected (and probably spent a ton of $$ collecting). Not doing this, means you just did a very expensive “experimental level” test that doesn't actually hold water when you go to the FDA.
For this reason, if you are not working under a Quality System, and want to do an experimental study that will impact the design of your product, but that will not end up in the final data submitted to FDA, we recommend using the IRB study as a fact finding mission.
This is because you can get an IRB study approved that utilizes devices that are at prototype level, whereas the clinical study requires finished designs with design history and traceability to execute (i.e. built under a quality system).
TL;DR: If you’re planning a clinical study, ensure that you’ll actually be able to submit the clinical data to FDA because the devices used were built under a quality system.
