5 Ways to Ensure your 510k Submission Testing Goes off Without a Hitch
By Engaged Expert Maciej Jakucki
Any engineer who has ever had a hand in the design or manufacture of a medical device understands the enormous pressure that an FDA 510(k) submission brings to a company, large or small. There are countless due dates, action items, and vendors to coordinate with during this high stakes process. And typically, mechanical testing is one of the last stops before submitting to the FDA.
Not surprisingly, some companies neglect to plan their testing initiatives in advance, and consequently, encounter delays in submission, which affect time to market, profitability, and even potentially the company’s long term success.
Avoid these undesirables by following our medical device testing Engaged Expert's advice to make mechanical testing the most effortless part of your 510(k) process:
1. Hire an FDA Consultant
We are often asked questions such as, “What does the FDA look for? What’s the bare minimum I can test and still pass? What predicate should I use?”
While these questions have merit, we recommend hiring a regulatory consultant who specializes in developing worst case rationales and executing 510(k) submissions. As an independent testing laboratory, Element has no affiliation with the FDA or any government agency. Our engineers can advise clients of typical trends and techniques we see employed, however, we are experts in testing, not the 510(k) process. By hiring a reliable consultant, you will have direct access to someone with years of experience with the FDA and the submission process. This person will know what the FDA is looking for and can help you plan ahead to avoid unpleasant surprises.
2. Feasibility Testing: Early and Often
Most people wouldn’t jump into a swimming pool without sticking a toe in first to test the waters. The same should be true for devices that are being designed for FDA 510(k) submission. Before finalizing a design or concept, it is critical to undergo multiple rounds of feasibility testing to ensure that the device has sufficient strength and fatigue properties. Feasibility testing is also useful for optimizing already sufficient designs by making small changes and testing the effect of those changes.
By investing a small amount up front in feasibility testing, you are saving the potential for failing the official submission tests, which would result in a catastrophic setback.
3. Know your Predicate(s)
Predicate devices are the subject of most questions we receive from implant designers and manufacturers. “Where can I find predicate data?” “How do I obtain predicates?” “Do I really need predicates?”
The answer is, yes, the FDA always requires an implant to be compared to a predicate device or predicate data. Therefore, predicate devices are one of the most important considerations for 510(k) submission, and should not be an afterthought. Whether you locate previously published predicate data or you procure predicate devices for side-by-side testing, make certain that the data or devices are acquired well ahead of schedule for testing. The predicate devices set the acceptance criteria for your testing projects and give a benchmark to measure against. Often times, multiple predicates are used.
4. Write Protocols Early
Test protocols are critical for 510(k) submissions. Often, clients believe that since they are testing to a known ASTM standard, that a protocol isn’t necessary. In other cases, clients assume that the test lab includes test protocols that are sufficient. Neither of these cases is true.
Protocols typically include much more information than the test methodology, such as rationale and justification of the worst case sizes, as well as information regarding indications, uses, drawings, deviations, etc. Thorough protocols can be used and “dropped” into the 510(k) submissions, and give a great structure for explanation of the rationale. Due to the length of time required to draft protocols, it’s critical to begin this process early. Be sure to explain any and all deviations in your protocol, along with other required documentation that your FDA consultant can assist you with (see #1).
While test labs can assist you with developing the testing-related portions of your protocol, usually labs are not privy to all the information required to build a comprehensive protocol. In addition, protocol development is typically considered a consulting service, which is billed in addition to the actual testing costs. Element frequently assists clients with protocol creation. Even more frequently, our clients have protocols already developed. In these cases, our team will review the protocols before a project begins and often are able to provide constructive feedback that saves time and money.
5. Be Generous with your Timeline
Pressure comes from many angles during the 510(k) submission process. Owners and investors, in particular, often press for extremely tight timelines for completing a submission. While this is understandable, designers and manufacturers should be careful to ensure that their proposed timelines are realistic and achievable. Only allowing three weeks for seven weeks of testing, for instance, is a surefire way to miss your submission deadline. Check with your testing partner ahead of time to get a feel for how much time will be needed to complete testing and to ensure availability. Element enables clients to schedule test frames months in advance, which eliminates the headache caused by having to wait in a lab’s queue when samples are finally available.
In many cases, manufacturers run into delays caused by other vendors. Because of this, companies often attempt to “make up the time” at the testing stage. In these cases, expedite options are generally available throughout the industry, but be sure to weigh the additional costs vs. the quicker turnaround of results when developing your time line. And be realistic with your expectations. Mechanical testing is too important of a process to rush through haphazardly.