New FDA Draft Guidance: FDA Provides 510(k) Cheat Code
The FDA recently released a DRAFT Guidance, “Evidentiary Expectations for 510(k) Implant Devices.” This is part of the FDA’s Safety Action Plan, which includes modernizing the 510(k) process, and in this case specifically giving additional clarity and transparency.
Overall, it is a very helpful and straightforward document. However, this document is most useful for smaller to medium sized firms, and not so much the large firms. For those smaller firms, they may not have the history and background to know what is expected for a 510(k), or just medical device design in general. This document acts a bit like a treasure map for the design and safety aspects that a firm needs to design into their devices.
As I am a big fan of the design control V-diagram, I used that as a framework to layout the different concepts that the draft guidance identifies:
You can see in the chart that it touches on all things across the design spectrum, and if you are somewhat new to medical devices, probably identifies some things that you may not be aware of. For instance, if a firm does not have much experience in implants, they may not account for the possibility of a patient being exposed to strong magnetic fields in an MRI machine. Also, real time and accelerated shelf-life testing for polymers, and other examples which are good for firms without much medical device experience.
I consider this a cheat code for the smaller firms, as the FDA is essentially giving out, for free, design considerations that firms need to understand when developing and verifying their device. In contrast, older and larger firms have learned these concepts already from their own blood, sweat and tears. If the FDA continues on this path, we soon won’t need medical device design consultants … uhoh.
There are some items to highlight that everyone would find useful:
Clarification on the importance of duration of use, and how that can drive the design, testing and how to leverage shorter time frame data (Line 182)
You don’t need to submit all your product and package testing data (Line 314, 347)
Functional testing should be done on aged and conditioned test samples (Line 330)
Specific design considerations for Magnetic Resonance (Line 430)
Firms can demonstrate particulates safety using similar devices (Line 499)
Examples on when animal testing may be needed (Line 583)
Human Factors/Usability Summative test should include representative user training (Line 693)
Information that should be provided to the patient (Line 756)
The draft guidance is specific to implants, so if you are creating a non-implant, not all of it will be applicable to your device. However, there is a lot of good information that is appropriate for any type of medical device, therefore you should give the draft guidance a good read for any type of device you might be designing.
One general improvement for the draft guidance is to better line up the recommendations with the different design control elements, e.g. design inputs, design verification, etc... I’ve seen many smaller firms just focus on getting a 510(k) clearance, and not really focus on creating a full DHF. Often the push is just to get the product on the market in the shortest and cheapest period of time. Because of the nature of small firms and the regulatory landscape, those smaller firms can release products with minimal oversite other than a 510(k) approval. A re-emphasis to those smaller firms that all of the QSR is required, including design controls, would improve the overall safety and efficacy of medical devices. On line 347 the draft guidance even uses the term “confirmatory testing,” when the term “verification testing” should be used to identify the importance of that testing. An integration of the concepts in the draft guidance with design control elements would truly allow firms to better integrate the guidance into their current processes. I’ve already done the work for them with the graphic I created above. I’ll even let them use it, on the house.
Overall, I like the steps that FDA is taking to make their processes more transparent and make it easier for companies to design and release more innovative, life saving devices. In summary, this new guidance give’s manufactures an way to press ↑ ↑ ↓ ↓ ← → ← → B A when it comes to the big design aspects they need to worry about.
